SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

Commission File No. 000-51290

EpiCept Corporation

(Exact name of registrant as specified in its charter)

Delaware		52-1841431
(State or other jurisdiction of		(IRS Employer Identification No.)
incorporation or organization)

777 Old Saw Mill River Road
Tarrytown, NY 10591
(Address of principal executive offices) (zip code)

Registrant’s telephone number, including area code: (914) 606-3500

Securities registered pursuant to Section 12(b) of the Act:
Common Stock, par value $.0001 per share
(Title of Class)

Securities registered pursuant to Section 12(g) of the Act:
None
(Title of Class)

Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No þ.

Indicate by check mark whether the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes o No þ.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o.

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendments to this Form 10-K. o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer o		Accelerated filer o		Non-accelerated filer o		Smaller reporting company þ

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ.

As of June 30, 2010, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of shares of common stock held by non-affiliates was $43,244,458.

As of March 30, 2011, the registrant had 70,989,292 shares of its common stock, par value $.0001 per share, outstanding.

 

 

TABLE OF CONTENTS

PART I
ITEM 1. BUSINESS			4
ITEM 1A. RISK FACTORS			16
ITEM 1B. UNRESOLVED STAFF COMMENTS			32
ITEM 2. PROPERTIES			32
ITEM 3. LEGAL PROCEEDINGS			32
ITEM 4. REMOVED AND RESERVED			32
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES			33
ITEM 6. SELECTED FINANCIAL DATA			34
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			36
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK			51
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA			52
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE			52
ITEM 9A. CONTROLS AND PROCEDURES			53
ITEM 9B. OTHER INFORMATION			53
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE			54
ITEM 11. EXECUTIVE COMPENSATION			54
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS			54
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE			54
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES			54
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES			55
SIGNATURES			56
Exhibit 21.1
Exhibit 23.1
Exhibit 31.1
Exhibit 31.2
Exhibit 32.1
Exhibit 32.2

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact included in this Form 10-K are forward-looking statements. Forward-looking statements give our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “should,” “can have,” “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events.

These forward-looking statements are based on assumptions that we have made in light of our industry experience and on our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances. As you read and consider this Form 10-K, you should understand that these statements are not guarantees of performance or results. They involve risks, uncertainties (some of which are beyond our control) and assumptions. Although we believe that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect our actual financial results and cause them to differ materially from those anticipated in the forward-looking statements. These factors include, among others:

	•		the risk that our securities may be delisted from Nasdaq;
	•		the risk that Ceplene® will not receive regulatory approval or marketing authorization in the United States or Canada;
	•		the risk that Ceplene® will not achieve significant commercial success;
	•		the risk that Ceplene® will not be reimbursed or receive an acceptable price for reimbursement in certain countries;
	•		the risk that any required post-approval clinical studies for Ceplene® will not be successful;
	•		the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene®;
	•		the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern;
	•		the risks associated with our ability to continue to meet our obligations under our existing debt agreements;
	•		the risk that Myrexis’s development of Azixa™ will not be successful;
	•		the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success;
	•		the risk that we will not receive any significant payments under our agreement with Myrexis;
	•		the risk that the development of our other apoptosis product candidates will not be successful;
	•		the risk that clinical trials for EpiCeptTM NP-1 or crolibulinTM will not be successful;
	•		the risk that EpiCeptTM NP-1 or crolibulinTM will not receive regulatory approval or achieve significant commercial success;
	•		the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCeptTM NP-1 on attractive terms, a timely basis or at all;
	•		the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials;
	•		the risk that we will not obtain approval to market any of our product candidates;
	•		the risks associated with dependence upon key personnel;
	•		the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates;
	•		the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process;
	•		our history of operating losses since our inception;
	•		the highly competitive nature of our business;
	•		risks associated with litigation;
	•		risks associated with our ability to protect our intellectual property; and
	•		the other factors described under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

There may be other factors that may cause our actual results to differ materially from the forward-looking statements. Because of these factors, we caution that you should not place undue reliance on any of our forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New risks and uncertainties arise from time to time, and it is impossible for us to predict those events or how they may affect us. Except as required by law, we have no duty to, and do not intend to, update or revise the forward-looking statements in this Form 10-K after the date of this Form 10-K. This Form 10-K also contains market data related to our business and industry. This market data includes projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by these data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, financial condition, results of operations and the market price of our common stock. We do not undertake to discuss matters relating to our ongoing clinical trials or our regulatory strategies beyond those which have already been made public or discussed herein. As used herein, references to “we,” “us,” “our,” “EpiCept” or the “Company” refer to EpiCept Corporation and its subsidiaries. References in this Form 10-K to the “FDA” means the U.S. Food and Drug Administration.

ITEM 1.		BUSINESS

We are a specialty pharmaceutical company focused on the clinical development and commercialization of pharmaceutical products for the treatment of cancer and pain. We focus our clinical development efforts on innovative cancer therapies and topically delivered analgesics targeting peripheral nerve receptors. Our lead product is Ceplene^®, which when used concomitantly with low-dose interleukin-2, or IL-2, is intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete remission. Ceplene^® is approved in the Europe Union, or EU, and Israel.

In addition to Ceplene^®, we have two other oncology compounds including crolibulin^TM, a novel small molecule vascular disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid tumors and Azixa^TM, an apoptosis inducer with VDA activity that is currently in Phase II clinical trials in patients with primary glioblastoma and cancer that has metastasized to the brain. We also have a late-stage pain product candidate, EpiCept^TM NP-1 cream, which we refer to as NP-1, for the treatment of peripheral neuropathies. We recently concluded a Phase IIb clinical trial of NP-1 in which we studied its safety and efficacy in patients suffering from chemotherapy-induced neuropathy, or CPN, compared with placebo. We believe this portfolio of oncology and pain management product candidates lessens our reliance on the success of any single product or product candidate.

Product Portfolio

The following chart illustrates the depth of our product pipeline at December 31, 2010:

Cancer

Cancer is the second leading cause of death in the United States. Half of all men and one third of all women in the United States will develop cancer during their lifetimes. Today, millions of people are living with cancer or have had cancer. Although there are many kinds of cancer, they are all caused by the out-of-control growth of abnormal cells. Normal body cells grow, divide, and die in an orderly fashion. During the early years of a person’s life, normal cells divide more rapidly until the person becomes an adult. After that, cells in most parts of the body divide only to replace worn-out or dying cells and to repair injuries. Because cancer cells continue to grow and divide, they are different from normal cells. Instead of dying, they outlive normal cells and continue to form new abnormal cells.

Cancer usually forms as a tumor. However, some cancers, like leukemia, do not form tumors. Instead, these cancer cells involve the blood and blood-forming organs and circulate through other tissues where they grow. Often, cancer cells travel to other parts of the body where they begin to grow and replace normal tissue. Different types of cancer can behave very differently. For example, lung cancer and breast cancer are very different diseases. They grow at different rates and respond to different treatments. That is why people with cancer need treatment that is aimed at their particular kind of cancer. The risk of developing most types of cancer can be reduced by changes in a person’s lifestyle, for example, by quitting smoking and following a better diet. The sooner a cancer is found and treatment begins, the better are the chances for long term survival.

Ceplene^®

AML is the most deadly and most common type of acute leukemia in adults. There are approximately 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Additionally, there are approximately 13,000 new cases of AML and 9,000 deaths caused by this cancer each year in the United States. Once diagnosed with AML, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70-80% of patients who achieve first complete remission will relapse, with the median time in remission before relapse with current treatments being only 12 months. Less than 15% of relapsed patients survive long-term.

Ceplene^® (histamine dihydrochloride) is our proprietary product for the remission maintenance and prevention of relapse in adult patients with AML in first remission. Ceplene^® is to be administered in conjunction with low-dose IL-2 and is designed to protect lymphocytes responsible for immune-mediated destruction of residual leukemic cells. Ceplene^®reduces the formation of oxygen radicals from phagocytes, inhibiting nicotinamide adenine dinucleotide phosphate-oxidase, or NADPH oxidase, and protecting IL-2-activated Natural Killer cells, or NK-cells, and Thymus cells, or T-cells. These two kinds of cells, NK-cells and T-cells, possess an ability to kill and support the killing of cancer cells and virally infected cells.

In October 2008, we received a full marketing authorization from the European Commission, or EU, for Ceplene^®. The approval allows Ceplene^® to be marketed in the 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway. The approval by the European Commission is based, in part, on the results of the single pivotal 320-patient Phase III trial for Ceplene^® in conjunction with low dose IL-2. The primary result of this trial was that treatment with Ceplene/IL-2 significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukemia-free survival in patients receiving Ceplene/IL-2 exceeded 50%. Moreover, Ceplene^® was well tolerated in this patient population and conferred an acceptable risk benefit profile for AML patients.

Ceplene is an Orphan Medicinal Product in the EU for the treatment of AML. As a result of its designation, we have been granted market exclusivity in the EU until October 2018. As part of receiving marketing authorization under Exceptional Circumstances for Ceplene^®, we are required to perform two post-approval clinical studies that have now been combined into a single clinical study. The first part of the study will seek to further elucidate the clinical pharmacology of Ceplene^® by assessing certain immune biomarkers in AML patients in first remission. The second part of the study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population.

In January 2010, we entered into an exclusive commercialization agreement for Ceplene^® with Meda AB, a leading international specialty pharmaceutical company based in Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market Ceplene^® in Europe and several other countries including Japan, China, and Australia. We received a $3 million fee on signing and received an additional $2 million upon the first commercial launch of Ceplene in a major European market. The commercial launch of Ceplene^® commenced in the United Kingdom in April 2010 and launches continue to be initiated in other European countries. We will also receive other milestone payments and an escalating percentage royalty on net sales in the covered territories. We are responsible for Ceplene’s commercial supply.

In November 2009, Health Canada screened and accepted for review a New Drug Submission (“NDS”) for Ceplene^® for remission maintenance treatment of AML in Canada. During the third quarter of 2010, our appeal of a decision by Health Canada not to provide data protection for Ceplene^® was denied by a federal court in Canada. Lack of data protection in Canada for an innovative drug such as Ceplene^® eliminates any right to sales exclusivity and enables competition to seek approval to sell generic equivalents immediately. In November 2010, we appealed the court’s decision and withdrew our New Drug Submission until the appeals process is completed. We retain the right to re-file the application at any time over the next five years without prejudice.

In June 2010, we filed a New Drug Application, or NDA, with the United States Food and Drug Administration, or FDA for Ceplene^® in the same indication. In August 2010, we received a refusal to file letter from the FDA on the NDA. In the FDA’s preliminary review of the NDA, the FDA concluded that the application did not establish Ceplene^®’s therapeutic contribution in its combination with IL-2, and recommended that an additional pivotal trial assessing Ceplene^®’s contribution and using overall survival as a primary endpoint be conducted. In October 2010, we reached an agreement with the FDA on a two-arm, randomized, open-label trial that will compare the efficacy of Ceplene^® plus low-dose IL-2 to standard of care in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. Our previous Phase III trial demonstrated a statistically significant prolongation of the primary endpoint of leukemia-free survival and extended overall survival by more than one year in patients in their first complete remission. As a next step, we will submit to the FDA a detailed Phase III protocol. The FDA, via the Special Protocol Assessment (SPA) procedure, will provide guidance on specific sections of the protocol including the adaptive design with prospectively defined rules for sample size selection for both futility and expected success. We also recently filed an application with the FDA to grant Ceplene^® fast track status. In addition to other benefits, if granted, this should permit an expedited review of the Ceplene^® NDA once it is filed.

In December 2010, Ceplene^® was approved for marketing in Israel. Megapharm Ltd. is EpiCept’s partner in Israel and upon Ministry of Health approval of labeling and other technical matters the company is expected to launch Ceplene^® in the first half of 2011.

Crolibulin^TM

Crolibulin^TM is a novel small molecule vascular disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid tumors. Crolibulin^TM has shown promising vascular targeting activity with potent anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated crolibulin^TM inhibits growth of established tumors of a number of different cancer types. In preclinical tumored animal models, combination therapy has demonstrated synergistic activity.

In November 2004, two publications appeared in Molecular Cancer Therapeutics discussing crolibulin^TM, a journal of the American Association of Cancer Research ( “Discovery and mechanism of action of a novel series of apoptosis inducers with potential vascular targeting activity”, Kasibhatla, S., Gourdeau, H., Meerovitch, K., Drewe, J., Reddy, S., Qiu, L., Zhang, H., Bergeron, F., Bouffard, D., Yang, Q., Herich, J., Lamothe, S., Cai, S. X., Tseng, B., Mol. Cancer Ther. 2004 vol. 3 pp. 1365-1374; and “Antivascular and antitumor evaluation of 2-amino-4-(3-bromo-4,5-dimethoxy-phenyl)-3-cyano-4H-chromenes, a novel series of anticancer agents”, Henriette Gourdeau, Lorraine Leblond, Bettina Hamelin, Clemence Desputeau, Kelly Dong, Irenej Kianicka, Dominique Custeau, Chantal Boudreau, Lilianne Geerts, Sui-Xiong Cai, John Drewe, Denis Labrecque, Shailaja Kasibhatla, and Ben Tseng, Mol. Cancer Ther. 2004 vol. 3 pp.1375-1384). The manuscripts characterize crolibulin^TM as a potent caspase activator demonstrating vascular targeting activity and potent antitumor activity in pre-clinical in vitro and in vivo studies. Crolibulin^TM appeared highly effective in mouse tumor models, producing tumor necrosis at doses that correspond to only 25% of the maximum tolerated dose, or MTD. Moreover, in combination treatment, crolibulin^TM significantly enhanced the antitumor activity of cisplatin/taxane, resulting in tumor-free animals.

In October 2007, we completed a Phase I clinical trial for crolibulin^TM. We successfully identified the maximum tolerated dose, or MTD, of crolibulin^TM in the Phase I study. The MTD was below the dose which produced the expected toxicity based on preclinical studies at higher doses. Crolibulin^TM was administered as a single agent in increasing doses to small cohorts of patients with advanced solid tumors. A total of seventeen patients were enrolled in the study. The drug was tested in a variety of cancer types including melanoma, prostate, lung, breast, colon, and pancreatic cancers. The study, which was initiated in December 2006, was conducted at three cancer centers in the United States. In addition to determining crolibulin’s MTD, the primary objective of the study was to determine the pharmacokinetic profile of the drug. In 2008, we enrolled an additional sixteen patients into the study, lengthening the infusion period of the drug in order to increase the MTD. The studies helped characterize the pharmacodynamic effects on tumor blood flow and identified early signs of objective anti-tumor response as measured by computed axial tomography, or CT scans, magnetic resonance imaging, or MRI, or positron emission tomography, or PET scan, in advanced cancer patients with well vascularized solid tumors.

In December 2010, the National Cancer Institute, or NCI, initiated a Phase II trial with crolibulin^TM. The trial will assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer, or ATC. The Phase II trial consists of two stages. The primary objective of the first stage is to assess the safety and tolerability of cisplatin and crolibulin^TM given in 21-day treatment cycles. The study will assess the toxicities of crolibulin^TM co-administered with cisplatin, evaluate dose-limiting toxicities, or DLTs, and determine the MTD for the combination. The primary objective in the second stage of the trial will be to compare the combination of crolibulin^TM and cisplatin against cisplatin alone in adult ATC patients by assessing the duration of progression-free survival, or PFS. An important secondary objective is the comparison of the response rates evaluated by Response Evaluation Criteria in Solid Tumors, or RECIST. Up to 70 patients are planned to be enrolled in the trial.

Azixaä

Azixa^TM is a compound discovered internally and licensed to Myrexis Inc. for clinical development. Azixa^TM demonstrated a broad range of anti-tumor activities against many tumor types in various animal models as well as activity against different types of multi-drug resistant cell lines. The Phase I clinical testing was conducted by Myrexis on patients with solid tumors with a particular focus on brain cancers or brain metastases due to the pharmacologic properties of Azixa^TM in pre-clinical animal studies that indicated higher drug levels in the brain than in the blood. In March 2007, Myrexis initiated two Phase II clinical trials for Azixa^TM in patients with primary brain cancer and in patients with melanoma that has spread to the brain. The trials are designed to assess the safety profile of Azixa^TM and the extent to which it can improve the overall survival of these patients. In June 2010, Myrexis reported results from two of the Phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO) that resulted in durable responses with no additive toxicity in patients. Updated results from an ongoing, open-label Phase 2a monotherapy study of Azixa™ in treatment-experienced patients with glioblastoma multiforme (GBM), an aggressive brain tumor, were presented in November 2010 demonstrating durable responses in patients who had failed both first and second line therapy. Data from a sub-group of patients with recurrent GBM who are naïve to Avastin is expected to be reported in the first half of 2011.

In December 2010, Myrexis began a Phase IIb clinical study of Azixa^TM to treat GBM. The study will enroll as many as 120 patients in the U.S. and India in order to evaluate Azixa^TM combination therapy as a first-line GBM treatment. Azixa^TM has received orphan drug status in the United States for the treatment of glioblastoma.

Peripheral Neuropathy

Peripheral neuropathy is a medical condition caused by damage to the nerves in the peripheral nervous system. The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. A 2006 study conducted by Business Insight stated that peripheral neuropathy affects over 15 million people in the United States and is associated with conditions that injure peripheral nerves, including herpes zoster, or shingles, diabetes, HIV/AIDS and other diseases. It can also be caused by trauma or may result from surgical procedures. Peripheral neuropathy is usually first felt as tingling and numbness in the hands and feet. Symptoms can be experienced in many ways, including burning, shooting pain, throbbing or aching. Peripheral neuropathy can cause intense chronic pain that, in many instances, is debilitating.

Post-herpetic neuralgia, or PHN, is one type of peripheral neuropathic pain associated with herpes zoster, or shingles, which exists after the rash has healed. According to Datamonitor, PHN affects over 100,000 people in the United States each year. PHN causes pain on and around the area of skin that was affected by the shingles rash. Most people with PHN describe their pain as “mild” or “moderate.” However, the pain can be severe in some cases. PHN pain is usually a constant, burning or gnawing pain but can be an intermittent sharp or stabbing pain. Current treatments for PHN have limited effectiveness, particularly in severe cases and can cause significant adverse side effects. One of the initial indications for our NP-1 product candidate is for the treatment of peripheral neuropathy in PHN patients.

Painful diabetic peripheral neuropathy, or DPN, is common in patients with long-standing Type 1(juvenile) and Type 2 (adult onset) diabetes mellitus. An estimated 18.2 million people have diabetes mellitus in the United States. The prevalence of neuropathy approaches 50% in those with diabetes mellitus for greater than 25 years. Specifically, the lifetime incidence of DPN is 11.6% and 32.1% for Type 1 and Type 2 diabetes, respectively. Common symptoms of DPN are sharp, stabbing, burning pain, or allodynia, which is pain to light touch, with numbness and tingling of the feet and sometimes the hands.

Various drugs are currently used in the treatment of DPN. These include tricyclic antidepressants, or TCA’s, such as amitriptyline, anticonvulsants such as gabapentin, serotonin and norepinephrine re-uptake inhibitors (e.g., duloxetine), and opioids (e.g., oxycodone). Unfortunately, the use of these drugs is often limited by the extent of the pain relief provided and the occurrence of significant central nervous system, or CNS, side effects such as dizziness, somnolence, and confusion. Because of its limited systemic absorption into the blood, NP-1 topical cream potentially fulfills the unmet need for a safe, better tolerated, and effective agent for painful DPN.

Cancer neuropathies represent a large unmet market. Neuropathic pain is caused by injury to, or compression of, the structures of the peripheral and central nervous system. Chemotherapy or radiotherapy treatments that patients receive for their cancer often results in neuropathic pain and is considered a side effect of the cancer treatment. Chemotherapeutic agents, including vinca alkaloids, cisplatin and paclitaxel, are associated with peripheral neuropathies. Neuropathic pain is often described as sharp, tingling, burning or shooting. The National Cancer Institute estimates that 30-40% of cancer patients treated with chemotherapy experience symptoms of CPN, which impairs their quality of life and ability to function. The debilitating, chronic pain of CPN is one of the most common reasons why cancer patients stop their treatment early. More than one million breast cancer survivors in the United States alone suffer from this disease, for which there is no effective therapy.

EpiCept^TM NP-1

EpiCept^TM NP-1, or NP-1, is a prescription topical analgesic cream containing a patented formulation of two FDA-approved drugs; amitriptyline, which is a widely-used antidepressant, and ketamine, an NMDA antagonist that is used as an intravenous anesthetic. NP-1 is designed to provide effective, long-term relief from the pain caused by peripheral neuropathies. Since each of these ingredients has been shown to have significant analgesic effects and because NMDA (N-methyl-D-aspartic acid) antagonists, such as ketamine, have demonstrated the ability to enhance the analgesic effects of amitriptyline, we believe the combination is a good candidate for the development of a new class of analgesics. We believe that NP-1 can be used in conjunction with orally delivered analgesics, such as gabapentin.

NP-1 is an odorless, white vanishing cream that is applied twice daily and is quickly absorbed into the applied area. We believe the topical delivery of its patented combination represents a fundamentally new approach for the treatment of pain associated with peripheral neuropathy. In addition, we believe that the topical delivery of our product candidate will significantly reduce the risk of adverse side effects and drug to drug interactions associated with the systemic delivery of the active ingredients. The results of our clinical trials to date have demonstrated the safety of the cream for use for up to one year and a potent analgesic effect in subjects with both post-herpetic neuralgia and other types of peripheral neuropathy, such as those with diabetic, traumatic and surgical causes.

In February 2011, we presented data from our Phase IIb trial for EpiCept™ NP-1 in chemotherapy-induced peripheral neuropathy, or CPN, which is being conducted by National Cancer Institute, or NCI. CPN may affect 50% of women undergoing treatment for breast cancer. A common therapeutic agent for the treatment of advanced breast cancer is paclitaxel, and as many as 80% of the patients with advanced breast cancer experience some signs and symptoms of CPN, such as burning, tingling pain associated sometimes with mild muscular weakness, after high dose paclitaxel administration. The multi-center, double-blind, randomized, placebo-controlled study was conducted within a network of approximately 25 sites under the direction of the NCI funded Community Clinical Oncology Program, or CCOP. More than 460 cancer survivors suffering from painful CPN were enrolled in the six-week study. The results of the trial in the intent to treat, or ITT, population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p<0.001), which was the trial’s primary endpoint. Additionally, a pre-specified subgroup of the ITT population, those patients who previously received taxane chemotherapy, also showed a statistically significant reduction in average daily neuropathy intensity scores (p=0.034). This subgroup constituted more than 50% of the ITT population. Secondary efficacy endpoints confirmed the superiority of NP-1 vs. placebo. Furthermore, the safety profile of NP-1 was comparable to placebo.

In January 2009, we completed a Phase IIb, multi-center, randomized, placebo controlled trial in approximately 360 patients evaluating the analgesic properties and safety of NP-1 cream in patients with PHN. This trial compared the efficacy and safety of NP-1 against both gabapentin, the leading drug prescribed for this indication, and placebo. The first primary endpoint was the change in pain intensity over the four week duration of the trial. The data demonstrated that NP-1 achieved statistically significant superior efficacy compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that NP-1 was not inferior to gabapentin in reducing pain, was also met. A key secondary endpoint measured in the trial from a responder analysis indicated that 63% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo arm (p=0.033). Top-line results further indicate that NP-1 achieved a superior safety profile when compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the reporting of adverse events. NP-1 has received orphan drug protection for the treatment of PHN.

In February 2008, we completed a Phase II clinical trial in 215 patients suffering from DPN. The results of this double-blind, placebo-controlled study demonstrated that the primary endpoint, the difference in changes in pain intensity between NP-1 and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715). The analgesic benefits of NP-1 continued to build over time during the course of the study. Key secondary endpoints measured in the trial from a responder analysis indicate that 60% of patients in the NP-1 treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the NP-1 treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain scores measured trended in favor of the NP-1 treated patients over the placebo group, indicative of an analgesic effect in this type of peripheral neuropathic pain. We concluded that data derived from the trial support the continued study of NP-1 in late-stage pivotal clinical trials.

Our Strategic Alliances

Meda AB

In January 2010, we entered into an exclusive commercialization agreement for Ceplene^® with Meda AB, a leading international specialty pharmaceutical company based in Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market Ceplene in Europe and several other countries including Japan, China, and Australia. Pursuant to the terms of the agreement, we received a $3 million fee on signing and an additional $2 million milestone payment in May 2010 upon the first commercial sale of Ceplene^® in a major European market. Additional potential payments include a $5 million payment upon achievement of a regulatory milestone and up to $30 million in sales-based milestones that commence upon attainment of at least $50 million in annual sales. We will receive an escalating percentage royalty on net sales in the covered territories ranging from the low teens to the low twenties and will be responsible for Ceplene’s commercial supply. The initial term of this agreement is ten years and is subject to automatic two year extensions at Meda’s option. The agreement can be terminated at any time by Meda upon six months’ prior written notice. The agreement can also be terminated by mutual agreement or for cause.

Myrexis, Inc.

We licensed the MX90745 series of caspase-inducer anti-cancer compounds to Myrexis in 2003. Under the terms of the agreement, we granted to Myrexis a research license to develop and commercialize any drug candidates from the series of compounds with a non-exclusive, worldwide, royalty-free license, without the right to sublicense the technology. Myrexis is responsible for the worldwide development and commercialization of any drug candidates from the series of compounds. We also granted to Myrexis a worldwide royalty bearing development and commercialization license with the right to sublicense the technology. The agreement requires that Myrexis make licensing, research and milestone payments to the Company totaling up to $27 million, of which $3.0 million was paid and recognized as revenue, assuming the successful commercialization of the compound for the treatment of cancer, as well as pay an escalating mid to high single digit percentage royalty on product sales. In March 2007, Myrexis initiated Phase II clinical trials for Azixa^TM, a MX90745 series compound. In March 2008, we received a milestone payment of $1.0 million following dosing of the first patient in these trials. In December 2010, Myrexis began a Phase IIb clinical study of Azixa^TM to treat glioblastoma multiforme, an aggressive brain tumor in order to evaluate Azixa^TM combination therapy as a first-line GBM treatment.

DURECT Corporation

In December 2006, we entered into a license agreement with DURECT Corporation, pursuant to which we granted DURECT the exclusive worldwide rights to certain of our intellectual property for a transdermal patch containing bupivacaine for the treatment of back pain. Under the terms of the agreement, we received a $1.0 million upfront payment. In September 2008, we amended our license agreement with DURECT. Under the terms of the amended agreement, we granted DURECT royalty-free, fully paid up, perpetual and irrevocable rights to the intellectual property licensed as part of the original agreement in exchange for a cash payment of $2.25 million from DURECT.

Endo Pharmaceuticals, Inc.

In December 2003, we entered into a license agreement with Endo under which we granted Endo (and its affiliates) the exclusive (including as to us and our affiliates) worldwide right to commercialize LidoPAIN BP, a lidocaine patch developed by EpiCept for the treatment of acute back pain. We also granted Endo worldwide rights to use certain of our patents for the development of certain other non-sterile, topical lidocaine patches, including Lidoderm^®, Endo’s non-sterile topical lidocaine-containing patch for the treatment of chronic lower back pain. Upon the execution of the Endo agreement, we received a non-refundable payment of $7.5 million. Other potential compensation under this agreement includes additional milestone payments of up to $82.5 million related to both our LidoPAIN BP product and Lidoderm^® and a royalty on net sales of LidoPAIN BP. We do not expect to receive further compensation under this agreement.

The last published clinical study of Lidoderm^® in back pain occurred in 2005. We believe that no measurable progress has occurred with Lidoderm^® for back pain and do not expect further revenue from this license at this time.

Manufacturing

We currently intend to outsource all of our manufacturing activities. We believe that this strategy will enable us to direct operational and financial resources to the development of our product candidates rather than diverting resources to establishing a manufacturing infrastructure. Under the terms of a supply agreement with Meda, we are responsible for supplying commercial quantities of Ceplene^® based on Meda’s estimate of sales in the licensed territories.

We have entered into arrangements with qualified third parties for the manufacture of Ceplene^® and for the formulation and manufacture of our clinical supplies. We may enter into additional written supply agreements in the future. We generally purchase our supplies from current suppliers pursuant to purchase orders. We plan to use a single, separate third party manufacturer for Ceplene^® and each of our product candidates for which we are responsible for manufacturing. In some cases, the responsibility to manufacture product, or to identify suitable third party manufacturers, may be assumed by our licensees. We cannot assure you that our current manufacturers can successfully increase their production to meet full commercial demand. We believe that in most cases there are several manufacturing sources available to us, including our current manufacturers, which can meet our commercial supply requirements on commercially reasonable terms. We will continue to look for and secure the appropriate manufacturing capabilities and capacity to ensure commercial supply at the appropriate time.

Sales and Marketing

We hired a small marketing staff in 2009 and 2010 in anticipation of the start of commercial activities for Ceplene^® in the United States. After receiving a refusal to file letter from the FDA on the NDA for Ceplene^®, we eliminated our marketing staff and scaled back our commercial activities in the United States. In order to commercially market Ceplene^® or any of our product candidates in the United States upon receipt of marketing approval, we must either develop an internal sales and marketing infrastructure or collaborate with third parties with sales and marketing expertise. We have retained the rights to commercialize NP-1 and crolibulin^TM worldwide and to market Ceplene globally except for Europe and certain Pacific rim countries. In addition, we have granted Myrexis exclusive worldwide commercialization rights, with rights to sublicense, for Azixa^TM. We will likely market our products in international markets outside of North America through collaborations with third parties. We intend to make decisions regarding internal sales and marketing of our product candidates on a product-by-product and country-by-country basis.

Intellectual Property

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our technologies and drug candidates as well as successfully defending these patents against third-party challenges. We have various compositions of matter and use patents, which have claims directed to our product candidates or their methods of use. Our patent policy is to retain and secure patents for the technology, inventions and improvements related to our core portfolio of product candidates. We also rely on trade secrets, technical know-how and continuing innovation to develop and maintain our competitive position.

The following is a summary of the patent position relating to our three in-house product candidates:

Ceplene^® — The intellectual property protection surrounding our histamine technology includes 24 U.S. patents issued or allowed, with the term for the latest one expiring in February 2023. Patents issued or pending in the international markets concern specific therapeutic areas or manufacturing. Claims include the therapeutic administration of histamine or any H2 receptor agonist in the treatment of cancer, infectious diseases and other diseases, either alone or in combination therapies, the novel synthetic method for the production of pharmaceutical-grade histamine dihydrochloride, the mechanism of action including the binding receptor and pathway, and the rate and route of administration.

Crolibulin^TM — The intellectual property protection regarding this compound is covered by two issued U.S. patents, with the latest one expiring in May 2022 and one application pending covering the composition and uses of this compound and structurally related analogs. Additional foreign patent applications are pending in major pharmaceutical markets outside the United States.

EpiCept^TM NP-1 — We own a U.S. patent with claims directed to a formulation containing a combination of amitriptyline and ketamine, which can be used as a treatment for the topical relief of pain, including neuropathic pain, that expires in August 2021. We also have a license to additional patents, which expire in September 2015 and May 2018, and which have claims directed to topical uses of tricyclic antidepressants, such as amitriptyline, and NMDA antagonists, such as ketamine, as treatments for relieving pain, including neuropathic pain.

We may seek to protect our proprietary information by requiring our employees, consultants, contractors, outside partners and other advisers to execute, as appropriate, nondisclosure and assignment of invention agreements upon commencement of their employment or engagement. We also require confidentiality or material transfer agreements from third parties that receive our confidential data or materials.

We also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, partners and other advisors may unintentionally or willfully disclose information to competitors. Enforcing a claim that a third party illegally obtained and is using trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

The pharmaceutical, biotechnology and other life sciences industries are characterized by the existence of a large number of patents and frequent litigation based upon allegations of patent infringement. While our drug candidates are in clinical trials, and prior to commercialization, we believe our current activities fall within the scope of the exemptions provided by 35 U.S.C. Section 271(e) in the United States and Section 55.2(1) of the Canadian Patent Act, each of which covers activities related to developing information for submission to the FDA and its counterpart agency in Canada. As our drug candidates progress toward commercialization, the possibility of an infringement claim against us increases. While we attempt to ensure that our drug candidates and the methods we employ to manufacture them do not infringe other parties’ patents and other proprietary rights, competitors or other parties may assert that we infringe on their proprietary rights.

For a discussion of the risks associated with our intellectual property, see Item 1A. “Risk Factors — Risks Relating to Intellectual Property.”

License Agreements

We have in the past licensed and will continue to license patents from collaborating research groups and individual inventors.

Epitome/Dalhousie

In August 1999, we entered into a sublicense agreement with Epitome Pharmaceuticals Limited under which we were granted an exclusive license to certain patents for the topical use of tricyclic anti-depressants and NMDA antagonists as topical analgesics for neuralgia that were licensed to Epitome by Dalhousie University. These and other patents cover the combination treatment consisting of amitriptyline and ketamine in NP-1. This technology has been incorporated into NP-1. In July 2007, we converted the sublicense agreement previously established with Epitome Pharmaceuticals Limited, related to NP-1, into a direct license with Dalhousie University. Under this new arrangement, we gained more favorable terms, including a lower maintenance fee obligation and reduced royalty rate on future product sales.

We have been granted worldwide rights to make, use, develop, sell and market products utilizing the licensed technology in connection with passive dermal applications. We are obligated to make payments to Dalhousie totaling $0.9 million, of which $0.2 million has been paid, upon achievement of specified milestones and to pay single-digit royalties based on annual net sales derived from the products incorporating the licensed technology. We are obligated to pay Dalhousie an annual maintenance fee of $0.5 million until the license agreement expires or is terminated, or an NDA for NP-1 is filed with the FDA, otherwise Dalhousie will have the option to terminate the contract. The license agreement with Dalhousie terminates upon the expiration of the last to expire licensed patent. The sublicense agreement with Epitome terminated in July 2007. During 2010, 2009 and 2008, we paid Epitome a fee of $0.0, $0.3 million and $0.3 million, respectively. During 2010, 2009 and 2008, we paid Dalhousie a maintenance fee of $0.5 million, $0.5 million and $0.4 million, respectively. These payments were expensed to research and development.

Hellstrand

In October 1999, we entered into a royalty agreement with Dr. Kristoffer Hellstrand under which we have an exclusive license to certain patents for Ceplene^® configured for the systemic treatment of cancer, infectious diseases, autoimmune diseases and other medical conditions. Under this agreement, we paid Dr. Hellstrand $1 million in 1999 and will owe a royalty of 1% of net sales. In November 2009 we expanded our collaboration with Dr. Hellstrand by concluding a new agreement in which we acquired rights to develop certain new compounds. As compensation for this agreement and for providing certain ongoing consulting services, we awarded Dr. Hellstrand options to purchase 50,000 shares of our common stock and agreed to pay a monthly consulting fee. During 2010 and 2009, Dr. Hellstrand earned $0.1 and $0 million in royalties based on net sales of Ceplene^®.

Shire Biochem

In March 2004 and as amended in January 2005, we entered into a license agreement reacquiring the rights to the MX2105 series of apoptosis inducer anti-cancer compounds from Shire BioChem, Inc., formerly known as BioChem Pharma, Inc., which had previously announced that oncology would no longer be a therapeutic focus of the company’s research and development efforts. Under the agreements, Shire BioChem agreed to assign and/or license to us rights it owned under or shared under its oncology research program. The agreement requires that we provide Shire BioChem a portion of any sublicensing payments we receive if we relicense the series of compounds, and make milestone payments to Shire BioChem totaling up to $26 million, assuming the successful commercialization of a compound for the treatment of a cancer indication, as well as pay a royalty on product sales. At December 31, 2010, we accrued a license fee of $0.6 million payable as a result of the commencement of a Phase I clinical trial for crolibulin^TM in 2006.

Government Regulation

United States

The FDA and comparable state and local regulatory agencies impose substantial requirements upon the clinical development, manufacture, marketing and distribution of drugs. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our product candidates. In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, and implementing regulations. The process required by the FDA before our product candidates may be marketed in the United States generally involves the following:

	•		completion of extensive pre-clinical laboratory tests, pre-clinical animal studies and formulation studies all performed in accordance with the FDA’s good laboratory practice, or GLP, regulations;
	•		submission to the FDA of an Investigational New Drug, or IND, application that must become effective before clinical trials may begin;
	•		performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;
	•		submission of an NDA to the FDA;
	•		satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product is produced to assess compliance with current GMP, or cGMP, regulations; and
	•		FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidates will be granted on a timely basis, if at all.

Pre-clinical Activities. Pre-clinical activities include laboratory evaluation of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals. The results of pre-clinical tests, together with manufacturing information and analytical data, are submitted as part of an IND application to the FDA. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Our submission of an IND, or those of our collaborators, may not result in FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development, and the FDA must grant permission before each clinical trial can begin. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center, and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations and regulations for informed consent of subjects.

Clinical Trials. For purposes of NDA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap:

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Phase I: Studies are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in subjects. In some cases, a sponsor may decide to run what is referred to as a “Phase Ib” evaluation, which is a second safety-focused Phase I clinical trial typically designed to evaluate the impact of the drug candidate in combination with currently approved drugs.

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Phase II: Studies are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the drug candidate for specific targeted indications and to determine dose tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials. In some instances, a sponsor may decide to run what is referred to as a “Phase IIa” clinical trial, which is designed to provide dose-ranging and additional safety and pharmaceutical data. In other cases, a sponsor may decide to run what is referred to as a “Phase IIb” evaluation, which is a second, confirmatory Phase II clinical trial that could, if positive and accepted by the FDA, serve as a pivotal clinical trial in the approval of a drug candidate.

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Phase III: These are commonly referred to as pivotal studies. When Phase II clinical trials demonstrate that a dose range of the drug candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

In some cases, the FDA may give conditional approval of an NDA for a drug candidate on the sponsor’s agreement to conduct additional clinical trials to further assess the drug’s safety and effectiveness after NDA approval. Such post-approval trials are typically referred to as Phase IV clinical trials.

New Drug Application. The results of drug candidate development, pre-clinical testing, chemistry and manufacturing controls and clinical trials are submitted to the FDA as part of an NDA. The NDA also must contain extensive manufacturing information. The FDA has 60 days to decide whether to file the NDA so that it can be reviewed. The FDA can refuse to file an application that is incomplete. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA’s Center for Drug Evaluation and Research (CDER) expects to review and act on at least 90 percent of NDAs for standard drugs no later than 10 months after the applications are received. The review goal is six months for priority drugs. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or an additional pivotal Phase III clinical trial. Even if such data is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. Once issued, the FDA may withdraw drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require us to develop additional data or conduct additional pre-clinical studies and clinical trials.

Satisfaction of FDA regulations and requirements or similar requirements of state, local and foreign regulatory agencies typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Government regulation may delay or prevent marketing of drug candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for new indications for our drug candidates on a timely basis, if at all. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific usages, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a drug may result in restrictions on the drug or even complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain, regulatory approvals for any of our drug candidates would harm its business. In addition, we cannot predict what additional governmental regulations may arise from future U.S. governmental action.

Any drugs manufactured or distributed by us or our collaborators pursuant to FDA approvals are subject to continuing regulation by the FDA, including record keeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to potential legal or regulatory action, such as warning letters, suspension of manufacturing, seizure of product, injunctive action or civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the NDA for that drug.

The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available drugs for uses that are not described in the drug’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, impose stringent restrictions on manufacturers’ communications regarding off-label use.

Section 505(b)(2) Drug Applications. Once an FDA-approved new drug is no longer patent-protected, another company may sponsor a new indication, a new use or put the drug in a new dosage form. Each new indication from a different company requires an NDA filing. As an alternate path to FDA approval for new or improved formulations of previously approved products, a company may file a Section 505(b)(2) NDA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. However, this NDA does not have to contain all of the information or data that was submitted with the original NDA because of the FDA’s prior experience with the drug product. An original NDA for an FDA-approved new drug would have required numerous animal toxicology studies that have been reviewed by the FDA. These can be referenced in the 505(b)(2) NDA submitted by the new applicant. Many studies in humans that support the safety of the drug product may be in the published literature. The FDA allows the new sponsor company to submit these publications to support its 505(b)(2) NDA. By allowing the new sponsor company to use this information, the time and cost required to obtain approval for a drug product for the new indication can be greatly reduced. The FDA may also require companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product candidate for all or some of the label indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.

To the extent that the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book publication. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. If the applicant does not challenge the listed patents, the Section 505(b)(2) application will not be approved until all the listed patents claiming the referenced product have expired. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired.

Foreign Regulation

Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement also vary greatly from country to country. Although governed by the applicable country, clinical trials conducted outside of the United States typically are administered with the three-phase sequential process that is discussed above under “Government Regulation — United States.” However, the foreign equivalent of an IND is not a prerequisite to performing pilot studies or Phase I clinical trials.

Under European Union regulatory systems, we may submit marketing authorization applications either under a centralized or decentralized procedure. The centralized procedure, which is required for oncology products and is available for medicines produced by biotechnology or which are highly innovative, provides for the grant of a single marketing authorization that is valid for all member states. This authorization is a marketing authorization application, or MAA. The decentralized procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval. This procedure is referred to as the mutual recognition procedure.

In addition, regulatory approval of prices is required in most countries other than the United States. We face the risk that the resulting prices would be insufficient to generate an acceptable return to us or our collaborators.

Corporate Information

We were incorporated in Delaware in March 1993. We have two wholly-owned subsidiaries, EpiCept GmbH, based in Munich, Germany, which is engaged in commercial activities on our behalf, and Maxim Pharmaceuticals, Inc., which is currently inactive. Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, NY, and our telephone number is (914) 606-3500. Our website address is www.epicept.com. Our website, and the information contained in our website, is not a part of this annual report.

Employees

As of March 30, 2011, our workforce consists of 14 full-time employees, three of whom hold a Ph.D. or M.D., and one of whom holds another advanced degree. We have no collective bargaining agreements with our employees and have not experienced any work stoppages. We believe that our relations with our employees are good.

Research and Development

Since our inception, we have made substantial investments in research and development. In the years ended December 31, 2010, 2009 and 2008, we incurred research and development expenses of $8.1 million, $11.6 million and $12.6 million, respectively.

Availability of SEC Filings

We have filed reports, proxy statements and other information with the SEC. Copies of our reports, proxy statements and other information may be inspected and copied at the public reference facilities maintained by the SEC at SEC Headquarters, Public Reference Section, 100 F Street, N.E., Washington D.C. 20549. The public may obtain information on the operation of the SEC’s public reference facilities by calling the SEC at 1-800-SEC-0330. The SEC maintains a website that contains reports, proxy statements and other information regarding us. The address of the SEC website is http://www.sec.gov. We will also provide copies of our Forms 8-K, 10-K, 10-Q, Proxy and Annual Report at no charge available through our website at www.epicept.com as soon as reasonably practicable after filing electronically such material with the SEC. Copies are also available, without charge, from EpiCept Corporation, 777 Old Saw Mill River Road, Tarrytown, NY, 10591.

ITEM 1A.		RISK FACTORS

An investment in our common stock involves a high degree of risk. You should carefully consider the risk factors described below as well as the other information contained in this Annual Report before buying shares of our common stock. If any of the following risks or uncertainties occurs, our business, financial conditions and operating results could be materially and adversely affected. As a result, the trading price of our common stock could decline and you may lose all or a part of your investment in our common stock.

Risks Relating to our Financial Condition

We have limited liquidity and, as a result, may not be able to meet our obligations.

As of December 31, 2010 we had approximately $2.4 million in cash and cash equivalents. In March 2011, we received $4.3 million cash, net of $0.3 million in transaction costs, from the issuance of approximately 7.1 million shares of our common stock and warrants to purchase 5.3 million shares of our common stock. In February 2011, we received $6.6 million cash, net of $0.5 million in transaction costs, from the issuance of approximately 8.9 million shares of our common stock and warrants to purchase 3.6 million shares of our common stock. Our anticipated average monthly cash operating expenses in 2011 is approximately $1.1 million per month. In addition, we are required to make an interest and principal payment to our lender tbg on June 30, 2011 in the amount of approximately $0.5 million. We believe that our cash is sufficient to fund operations into 2012. We may receive cash from certain of our licensing partners during 2011 for achievement of clinical milestones, and we may raise additional funds through the issuance of debt and/or equity to meet our cash needs. To conserve cash, we may delay or cancel some of our planned development activities that are not related to Ceplene^® during 2011.

In November 2010 we provided an update with respect to our financing plans. The key element of the plan is a non-equity financing transaction that, if fully completed, will support our operations for an additional year. We anticipate that the transaction, which is subject to completion of due diligence and execution of mutually-satisfactory documentation, will close in 2011, but should the transaction not close or the proceeds be less than anticipated we may determine to seek additional or alternative sources or types of financing, including equity financing.

We plan to out license our NP-1 compound to a third party who will agree to complete clinical development and commercialize the product upon receipt of necessary regulatory approvals. Discussions with prospective partners are continuing, however at this time we are unable to determine whether or when such an agreement might be concluded or the amount of any fees that may be paid to us in 2011 in connection with the agreement.

If additional funds are raised by issuing equity, substantial dilution to existing shareholders may result. If we fail to obtain capital when required, we may be forced to delay, scale back, or eliminate some or all of our commercialization and clinical efforts for Ceplene^® and our research and development programs or to cease operations entirely.

We have a history of losses and have never generated significant revenue from product sales and we expect to incur substantial losses in the future.

We have incurred significant losses since our inception, and we expect that we will experience net losses and negative cash flow for the foreseeable future. Since our inception in 1993, we have incurred significant net losses in each year. Our losses have resulted principally from expenses incurred in connection with our development activities and from general and administrative expenses associated with our operations. Our net loss for the years ended December 31, 2010, 2009 and 2008 was $15.5 million, $38.8 million and $25.4 million, respectively. As of December 31, 2010 and 2009, our accumulated deficit was $250.6 million and $235.0 million, respectively. We may never generate sufficient net revenue to achieve or sustain profitability.

We expect to continue to incur significant expenses over the next several years as we:

	•		apply for marketing approval of Ceplene® in the U.S., Canada, and other countries
	•		continue to conduct clinical trials for Ceplene® and our product candidates;
	•		seek regulatory approvals for Ceplene® and our product candidates;
	•		develop, formulate and commercialize our product candidates;
	•		implement additional internal controls and reporting systems and further develop our corporate infrastructure;

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acquire or in-license additional products or technologies or expand the use of our technologies; and

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maintain, defend and expand the scope of our intellectual property.

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hire additional personnel.

We expect that we will have large fixed expenses in the future, including significant expenses for research and development and selling, general and administrative expenses. We will need to generate significant revenues to achieve and maintain profitability. If we cannot successfully develop, obtain regulatory approvals for and commercialize our product candidates, we will not be able to generate significant revenue from product sales or achieve profitability in the future. As a result, our ability to achieve and sustain profitability will depend on our ability to generate and sustain substantially higher revenue while maintaining reasonable cost and expense levels.

We may not be able to continue as a going concern.

Our recurring losses from operations and our stockholders’ deficit raise substantial doubt about our ability to continue as a going concern and as a result our independent registered public accounting firm included an explanatory paragraph in its report on our consolidated financial statements for the year ended December 31, 2010, which is included herein, with respect to this uncertainty. We will need to generate significant revenue from the sale of Ceplene^® or raise additional capital to continue to operate as a going concern. In addition, the perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations and may adversely affect our ability to raise additional capital.

Our quarterly financial results are likely to fluctuate significantly, which could have an adverse effect on our stock price.

Our quarterly operating results will be difficult to predict and may fluctuate significantly from period to period, particularly because we are a relatively small company and we have not generated any meaningful revenue to date. The level of our revenues and expenses and our results of operations at any given time could fluctuate as a result of any of the following factors:

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research and development expenses incurred and other operating expenses;

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results of our clinical trials;

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our ability to obtain regulatory approval for our product candidates;

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our ability to achieve milestones under our strategic relationships on a timely basis or at all;

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timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;

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regulatory approvals and legislative changes affecting the products we may offer or those of our competitors;

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our ability to establish and maintain a productive sales force;

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demand and pricing of any of our products;

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physician and patient acceptance of our products;

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levels of third-party reimbursement for our products;

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interruption in the manufacturing or distribution of our products;

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the effect of competing technological and market developments;

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litigation involving patents, licenses or other intellectual property rights; and

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product failures or product liability lawsuits.

With the exception of Ceplene^®, we have not yet obtained regulatory approval for any of our product candidates. In addition, we do not manufacture products ourselves or conduct significant sales and marketing activities. Consequently, it is difficult to make any predictions about our future success, viability or profitability based on our historical operations. It is also difficult to predict the timing of the achievement of various milestones under our strategic relationships. In addition, our operating expenses may continue to increase as we develop product candidates and build commercial capabilities. Accordingly, we may experience significant quarterly losses.

Because of these factors, our operating results in one or more future quarters may fail to meet the expectations of securities analysts or investors, which could cause our stock price to decline significantly.

We have had limited operating activities, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Our activities to date have been limited to organizing and staffing our operations, acquiring, developing and securing our technology, licensing product candidates, and undertaking preclinical and clinical studies and clinical trials. With the exception of Ceplene^®, we have not yet demonstrated an ability to obtain regulatory approval, manufacture products or conduct sales and marketing activities. Consequently, it is difficult to make any predictions about our future success, viability or profitability based on our historical operations.

Clinical and Regulatory Risks

Other than the marketing authorization for Ceplene^® in the European Union and Israel, we currently have no products approved for sale and we cannot guarantee you that we will ever obtain regulatory approval for such other product candidates, which could delay or prevent us from being able to generate revenue from product sales.

All of our product candidates are subject to extensive government regulations related to development, clinical trials, manufacturing and commercialization. The process of obtaining approvals from the FDA, European Medicines Agency for the Evaluation of Medicinal Products, or EMA, and other governmental and similar international regulatory agencies is costly, time consuming, uncertain and subject to unanticipated delays. The FDA, EMA and similar international regulatory authorities may not ultimately approve the candidate for commercial sale in any jurisdiction. Despite the fact we received the marketing authorization for Ceplene^® in the European Union and Israel, we may not receive regulatory approval outside of the European Union and Israel, including in the United States or Canada. The FDA, EMA and similar international regulators may refuse to approve an application for approval of a drug candidate if they believe that applicable regulatory criteria are not satisfied. The FDA, EMA or similar international regulators may also require additional testing for safety and efficacy. Any failure or delay in obtaining these approvals could prohibit or delay us from marketing product candidates. If our other product candidates do not meet applicable regulatory requirements for approval, we may not have the financial resources to continue research and development of these product candidates and we may not generate significant revenues from the commercial sale of any of our products.

To obtain regulatory approval for our other product candidates, we or our partners must conduct extensive human tests, which are referred to as clinical trials, as well as meet other rigorous regulatory requirements. Satisfaction of all regulatory requirements typically takes many years and requires the expenditure of substantial resources.

We currently have several product candidates in various stages of clinical testing. All of our product candidates are prone to the risks of failure inherent in drug development and testing. Product candidates in later-stage clinical trials may fail to show desired safety and efficacy traits despite having progressed through initial clinical testing. In addition, the data collected from clinical trials of our product candidates may not be sufficient to support regulatory approval, or regulators could interpret the data differently than we do. The regulators may require us or our partners to conduct additional clinical testing, in which case we would have to expend additional time and resources. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in regulatory policy that occur prior to or during regulatory review.

We and other drug development companies have suffered set backs in late-stage clinical trials even after achieving promising results in early stage development. Accordingly, the results from completed preclinical studies and early stage clinical trials may not be predictive of results in later stage trials and may not be predictive of the likelihood of regulatory approval. Any failure or significant delay in completing clinical trials for our product candidates, or in receiving regulatory approval for the sale of our product candidates, may severely harm our business and delay or prevent us from being able to generate revenue from product sales, and our stock price will likely decline.

We may not be able to obtain regulatory approval in the United States for Ceplene^®, our lead product candidate, which could delay or prevent us from being able to generate revenue from sales of Ceplene^®, and require additional expenditures.

None of our products has received regulatory approval in the United States. In August 2010, we received a refusal to file letter from the U.S. Food and Drug Administration (FDA) on our New Drug Application (NDA) for Ceplene^®.

In October 2010, we reached an agreement on all outstanding issues with the FDA on a regulatory path forward for Ceplene^®. The FDA indicated that a new trial should be conducted. As a next step, we will submit a detailed Phase III protocol. The FDA, via the Special Protocol Assessment (SPA) procedure, will provide guidance on specific sections of the protocol. However, it will take a considerable amount of time and money to conduct a new trial, and we may not be able to obtain the necessary financing to see a new trial through to completion. Even if we are able to complete a new trial, the trial may not be successful, and even if the new trial is successful and we submit a new NDA for Ceplene^®, the FDA may nevertheless again issue a refusal to file, which means the FDA will not review our NDA, or even if it files our NDA it may recommend that our NDA not be approved.

If the FDA accepts our submission, we may be unsuccessful in our efforts to obtain a marketing approval from the FDA. In the event we do not obtain marketing approval, we may appeal, but such an appeal may not be successful. A negative decision would delay or prevent us from generating revenue from product sales of Ceplene^® in the United States for the foreseeable future and may require us to conduct additional costly and time-consuming clinical trials.

The FDA may also require additional testing for safety and efficacy. Any failure or delay in obtaining a filing decision or an approval could prohibit or delay us from marketing product candidates. If our product candidates do not meet applicable regulatory requirements for approval, we may not have the financial resources to continue research and development of these product candidates, and we may not generate significant revenues from the commercial sale of any of our products in the U.S.

We may not be able to maintain data protection in Canada for Ceplene^®, which could limit our ability to generate revenue from sales of Ceplene^® in Canada.

In November 2009, Health Canada accepted for review a New Drug Submission, or NDS, for Ceplene^® for the treatment of AML in Canada. We received a denial for data protection for Ceplene^® in Canada in the fourth quarter of 2009. We are currently appealing this denial for data protection. In November 2010, we withdrew our application for approval of Ceplene^® in Canada. We retain the right to re-file the application at any time over the next five years without prejudice. If we are unable to maintain data protection in Canada for Ceplene^®, we may never generate revenue from sales of Ceplene^® in Canada.

Clinical trial designs that were discussed with regulatory authorities prior to their commencement may subsequently be considered insufficient for approval at the time of application for regulatory approval.

We or our partners discuss with and obtain guidance from regulatory authorities on clinical trial protocols. Over the course of conducting clinical trials, circumstances may change, such as standards of safety, efficacy or medical practice, which could affect regulatory authorities’ perception of the adequacy of any of our clinical trial designs or the data we develop from our studies. Changes in circumstances could affect our ability to conduct clinical trials as planned. Even with successful clinical safety and efficacy data, we may be required to conduct additional, expensive trials to obtain regulatory approval.

We may not be able to maintain European Union regulatory approval for Ceplene^®, our lead product candidate, which could delay or prevent us from being able to generate revenue from sales of Ceplene^® and require additional expenditures.

Ceplene^® is our lead product candidate and our only product candidate currently under regulatory consideration. In October 2008, Ceplene^® was granted full marketing authorization by the European Commission, which allows Ceplene^® to be marketed in the 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Ceplene^® is to be administered in conjunction with low-dose interleukin-2 (IL-2). As part of granting the marketing authorization under Exceptional Circumstances, we have agreed to perform two post-approval clinical studies, that have now been combined into a single clinical study. The first part of the study will seek to further elucidate the clinical pharmacology of Ceplene^® by assessing certain biomarkers in AML patients in first remission. The second part of the study will assess the effect of Ceplene^®/IL-2 on the development of minimal residual disease in the same patient population. We may not receive a positive outcome in this study, and our marketing authorization in the European Union may be terminated. A negative outcome or terminated marketing authorization would delay or prevent us from generating revenue from product sales of Ceplene^® and may require us to conduct additional costly and time-consuming clinical trials. There is no assurance that we will be able to maintain governmental regulatory approvals to market Ceplene^® in Europe. If we are unable to maintain regulatory approval to market Ceplene^® in Europe, our business, financial condition and results of operations would be materially and adversely affected.

If we receive regulatory approval, our marketed products will also be subject to ongoing FDA and/or foreign regulatory agency obligations and continued regulatory review, and if we fail to comply with these regulations, we could lose approvals to market any products, and our business would be seriously harmed.

Following initial regulatory approval of any of our product candidates, we will be subject to continuing regulatory review, including review of adverse experiences and clinical results that are reported after our products become commercially available. This would include results from any post-marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we use to make any of our product candidates will also be subject to periodic review and inspection by the FDA or foreign regulatory agencies. If a previously unknown problem or problems with a product, manufacturing or laboratory facility used by us is discovered, the FDA or foreign regulatory agency may impose restrictions on that product or on the manufacturing facility, including requiring us to withdraw the product from the market. Any changes to an approved product, including the way it is manufactured or promoted, often require FDA approval before the product, as modified, can be marketed. We and our manufacturers will be subject to ongoing FDA requirements for submission of safety and other post-market information. If we or our manufacturers fail to comply with applicable regulatory requirements, a regulatory agency may:

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issue warning letters;

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impose civil or criminal penalties;

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suspend or withdraw regulatory approval;

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suspend any ongoing clinical trials;

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refuse to approve pending applications or supplements to approved applications;

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impose restrictions on operations;

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close the facilities of manufacturers; or

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seize or detain products or require a product recall.

In addition, the policies of the FDA or other applicable regulatory agencies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature, or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad.

Any regulatory approval we receive for our product candidates will be limited to those indications and conditions for which we are able to show clinical safety and efficacy.

Any regulatory approval that we may receive for our current or future product candidates will be limited to those diseases and indications for which such product candidates are clinically demonstrated to be safe and effective. For example, in addition to the FDA approval required for new formulations, any new indication to an approved product also requires FDA approval. If we are not able to obtain regulatory approval for a broad range of indications for our product candidates, our ability to effectively market and sell our product candidates may be greatly reduced and may harm our ability to generate revenue.

Our lead product candidate, Ceplene^®, which when used concomitantly with low-dose interleukin-2, is intended only for remission maintenance therapy in the treatment of AML for adult patients in their first complete remission. Any other indications or uses of Ceplene^® would require additional regulatory approval for us to market Ceplene^® for these indications.

While physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical studies and approved by regulatory authorities, our regulatory approvals will be limited to those indications that are specifically submitted to the regulatory agency for review. These “off-label” uses are common across medical specialties and may constitute the best treatment for many patients in varied circumstances. Regulatory authorities in the United States generally do not regulate the behavior of physicians in their choice of treatments. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the subject of off-label use. If our promotional activities fail to comply with these regulations or guidelines, we may be subject to warnings from, or enforcement action by, these authorities. In addition, our failure to follow regulatory rules and guidelines relating to promotion and advertising may cause the regulatory agency to delay its approval or refuse to approve a product, the suspension or withdrawal of an approved product from the market, recalls, fines, disgorgement of money, operating restrictions, injunctions or criminal prosecutions, any of which could harm our business.

The results of our clinical trials are uncertain, which could substantially delay or prevent us from bringing our product candidates to market.

Before we can obtain regulatory approval for a product candidate, we must undertake extensive clinical testing in humans to demonstrate safety and efficacy to the satisfaction of the FDA or other regulatory agencies. Clinical trials are very expensive and difficult to design and implement. The clinical trial process is also time consuming. The commencement and completion of our clinical trials could be delayed or prevented by several factors, including:

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delays in obtaining regulatory approvals to commence or continue a study;

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delays in reaching agreement on acceptable clinical trial parameters;

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slower than expected rates of patient recruitment and enrollment;

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inability to demonstrate effectiveness or statistically significant results in our clinical trials;

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unforeseen safety issues;

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uncertain dosing issues;

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inability to monitor patients adequately during or after treatment; and

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inability or unwillingness of medical investigators to follow our clinical protocols.

We cannot assure you that our planned clinical trials will begin or be completed on time or at all, or that they will not need to be restructured prior to completion. Significant delays in clinical testing will impede our ability to commercialize our product candidates and generate revenue from product sales and could materially increase our development costs. Completion of clinical trials may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a drug candidate. The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including:

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the number of sites included in the trials;

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the length of time required to enroll suitable patient subjects;

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the number of patients that participate in the trials;

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the number of doses that patients receive;

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the duration of follow-up with the patient;

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the product candidate’s phase of development; and

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the efficacy and safety profile of the product.

The use of FDA-approved therapeutics in certain of our pain product candidates could require us to conduct additional preclinical studies and clinical trials, which could increase development costs and lengthen the regulatory approval process.

Certain of our pain product candidates utilize proprietary formulations and topical delivery technologies to administer FDA-approved pain management therapeutics. We may still be required to conduct preclinical studies and clinical trials to determine if our product candidates are safe and effective. In addition, we may also be required to conduct additional preclinical studies and Phase I clinical trials to establish the safety of the topical delivery of these therapeutics and the level of absorption of the therapeutics into the bloodstream. The FDA may also require us to conduct clinical studies to establish that our delivery mechanisms are safer or more effective than the existing methods for delivering these therapeutics. As a result, we may be required to conduct complex clinical trials, which could be expensive and time-consuming and lengthen the anticipated regulatory approval process.

In some instances, we rely on third parties, over which we have little or no control, to conduct clinical trials for our products and their failure to perform their obligations in a timely or competent manner may delay development and commercialization of our product candidates.

The nature of clinical trials and our business strategy requires us to rely on clinical research centers and other third parties to assist us with clinical testing and certain research and development activities, such as our agreement with Myrexis, Inc. related to the MX90745 series of apoptosis-inducer anti-cancer compounds. As a result, our success is dependent upon the success of these third parties in performing their responsibilities. We cannot directly control the adequacy and timeliness of the resources and expertise applied to these activities by such third parties. If such contractors do not perform their activities in an adequate or timely manner, the development and commercialization of our product candidates could be delayed. In addition, we rely on Myrexis for research and development related to the MX90745 series of apoptosis-inducer anti-cancer compounds. We may enter into similar agreements from time to time with additional third parties for our other product candidates whereby these third parties undertake significant responsibility for research, clinical trials or other aspects of obtaining FDA approval. As a result, we may face delays if Myrexis or these additional third parties do not conduct clinical studies and trials, or prepare or file regulatory related documents, in a timely or competent fashion. The conduct of the clinical studies by, and the regulatory strategies of, Myrexis or these additional third parties, over which we have limited or no control, may delay or prevent regulatory approval of our product candidates, which would delay or limit our ability to generate revenue from product sales.

Risks Relating to Commercialization

We and our partner may not be able to successfully market and sell Ceplene^®.

Even though Ceplene^® was granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission, our partner, Meda AB, may not be able to effectively market and sell Ceplene^®. We are reliant on Meda AB to generate revenue from sales of Ceplene^® in Europe and certain other countries on our behalf.

We expect to incur substantial net losses, in the aggregate and on a per share basis, for the foreseeable future as Meda AB launches and commercializes Ceplene^® and we seek FDA approval to market Ceplene^® in the United States. We are unable to predict the extent of these future net losses, or when we may attain profitability, if at all. These net losses, among other things, have had and will continue to have an adverse effect on our stockholders’ deficit. We anticipate that for the foreseeable future our ability to generate revenues and achieve profitability will be dependent on the successful commercialization of Ceplene^®. If we are unable to generate significant revenue from Ceplene^®, or attain profitability, we may not be able to sustain our operations.

Ceplene^® may fail to achieve market acceptance, which could harm our business.

Even though Ceplene^® was granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission, physicians may choose not to prescribe this product, and third-party payers may choose not to pay for it. Accordingly, we may be unable to generate significant revenue or become profitable.

Acceptance of Ceplene^® will depend on a number of factors including:

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acceptance of Ceplene® by physicians and patients as a safe and effective treatment;

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availability of reimbursement for our product from government or healthcare payors;

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cost effectiveness of Ceplene®;

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the effectiveness of our and Meda’s or collaboration partners’ sales and marketing efforts;

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relative convenience and ease of administration;

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safety and efficacy;

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prevalence and severity of side effects; and

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availability of competitive products.

If Ceplene^® fails to achieve market acceptance, our business, financial condition and results of operations would be materially and adversely affected.

We are dependent upon collaborative arrangements for the further development and commercialization of Ceplene^®. These collaborative arrangements may place the development and commercialization of Ceplene^® outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us.

We have entered into a collaborative arrangement with Meda to market and sell Ceplene^® in Europe and certain other countries and we may enter into other collaborations with third parties to further develop and commercialize Ceplene^®. We may not be able to enter into collaborative arrangements on attractive terms, on a timely basis or at all. Dependence on collaborators for the development and commercialization of Ceplene^® subjects us to a number of risks, including:

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we may not be able to control the amount and timing of resources that our collaborators devote to the development or commercialization of Ceplene® or to their marketing and distribution, which could adversely affect our ability to obtain milestone and royalty payments;

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disputes may arise between us and our collaborators that result in the delay or termination of the commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;

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our collaborators may experience financial difficulties;

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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to expose us to potential litigation, jeopardize or lessen the value of our proprietary information, or weaken or invalidate our intellectual property rights;

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business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;

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a collaborator could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and

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the collaborations may be terminated or allowed to expire, which would delay product development and commercialization efforts.

If our arrangement with Meda is not successful or we are not able to enter into other collaborative arrangements on commercially attractive terms, on a timely basis or at all, or if any of the risks occur and we are unable to successfully manage such risks, our business, financial condition and results of operations would be materially and adversely affected.

If we fail to enter into and maintain successful strategic alliances for our product candidates, we may have to reduce or delay our product commercialization or increase our expenditures.

Our strategy for developing, manufacturing and commercializing potential product candidates in multiple therapeutic areas currently requires us to enter into and successfully maintain strategic alliances with pharmaceutical companies that have product development resources and expertise, established distribution systems and direct sales forces to advance our development programs and reduce our expenditures on each development program and market any products that we may develop. We have formed a strategic alliance with Myrexis with respect to the MX90745 series of apoptosis-inducer anti-cancer compounds and with DURECT for our intellectual property for a transdermal patch containing bupivacaine for the treatment of back pain. We may not be able to negotiate additional strategic alliances on acceptable terms, or at all.

We have entered into collaborative arrangements with respect to marketing or selling Ceplene^® in Europe, certain Pacific rim countries and Israel. We may rely on collaborative partners to market and sell Ceplene^® in other international markets. We cannot assure you that we will be able to enter into any more such arrangements on terms favorable to us, or at all.

If we are unable to maintain our existing strategic alliances or establish and maintain additional strategic alliances, we may have to limit the size or scope of, or delay, one or more of our product development or commercialization programs, or undertake the various activities at our own expense. In addition, our dependence on strategic alliances is subject to a number of risks, including:

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the inability to control the amount or timing of resources that our collaborators may devote to developing the product candidates;

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the possibility that we may be required to relinquish important rights, including intellectual property, marketing and distribution rights;

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the receipt of lower revenues than if we were to commercialize such products ourselves;

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our failure to receive future milestone payments or royalties should a collaborator fail to commercialize one of our product candidates successfully;

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the possibility that a collaborator could separately move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors;

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the possibility that our collaborators may experience financial difficulties;

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business combinations or significant changes in a collaborator’s business strategy that may adversely affect that collaborator’s willingness or ability to complete its obligations under any arrangement; and

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the chance that our collaborators may operate in countries where their operations could be negatively impacted by changes in the local regulatory environment or by political unrest.

If the market does not accept and use our product candidates, we will not achieve sufficient product revenues and our business will suffer.

If we receive regulatory approval to market our product candidates, physicians, patients, healthcare payors and the medical community may not accept and use them. The degree of market acceptance and use of any approved products will depend on a number of factors, including:

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perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;

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cost effectiveness of our products relative to competing products;

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relative convenience and ease of administration;

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availability of reimbursement for our products from government or healthcare payors; and

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effectiveness of marketing and distribution efforts by us and our licensees and distributors.

Because we expect to rely on sales and royalties generated by our current lead product, Ceplene^®, for a substantial portion of our product revenues for the foreseeable future, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional funding to continue our other development programs.

Our product candidates could be rendered obsolete by technological change and medical advances, which would adversely affect the performance of our business.

Our product candidates may be rendered obsolete or uneconomical by the development of medical advances to treat the conditions that our product candidates are designed to address. Pain management therapeutics are the subject of active research and development by many potential competitors, including major pharmaceutical companies, specialized biotechnology firms, universities and other research institutions. Research and development by others may render our technology or product candidates obsolete or noncompetitive or result in treatments or cures superior to any therapy we developed. Technological advances affecting costs of production could also harm our ability to cost-effectively produce and sell products.

We have no manufacturing capacity and anticipate continued reliance on third parties for the manufacture of our product candidates.

We do not currently operate manufacturing facilities for Ceplene^® or any of our product candidates. We lack the resources and the capabilities to manufacture Ceplene^® or any of our product candidates. We currently rely on one or more contract manufacturers for Ceplene^® and each product candidate to supply, store and distribute drug supplies for commercial use and for our clinical trials. Any performance failure or delay on the part of our existing manufacturers could result in lost sales or delay clinical development or regulatory approval of our product candidates and their commercialization, producing additional losses and depriving us of potential product revenues.

If the FDA or other regulatory agencies approve any of our product candidates for commercial sale, the product will need to be manufactured in larger quantities. Some of our product candidates have been manufactured in only small quantities for preclinical and clinical trials. In those cases, our third party manufacturers may not be able to successfully increase their manufacturing capacity in a timely or economical manner, or at all. We may be forced to identify alternative or additional third party manufacturers, which may prove difficult because the number of potential manufacturers is limited and the FDA must approve any replacement contractor prior to manufacturing our products. Such approval would require new testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our product candidates. It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all. If we are unable to successfully increase the manufacturing capacity for a drug candidate in a timely and economical manner, the regulatory approval or commercial launch of any related products may be delayed or there may be a shortage in supply, both of which may have an adverse effect on our business.

Our product candidates require precise, high quality manufacturing. A failure to achieve and maintain high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business. Manufacturers often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages of qualified personnel. These manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the U.S. Drug Enforcement Agency and corresponding state and foreign agencies to ensure strict compliance with current Good Manufacturing Practice and other applicable government regulations and corresponding foreign standards; however, we do not have control over third party manufacturers’ compliance with these regulations and standards. If one of our manufacturers fails to maintain compliance, the production of our product candidates could be interrupted, resulting in delays, additional costs and potentially lost revenues. Additionally, third-party manufacturers must pass a pre-approval inspection before we can obtain marketing approval for any of our products in development.

Furthermore, our existing and future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store and distribute our product candidates. We may not own, or may have to share, the intellectual property rights to such innovation. In the event of a natural disaster, equipment failure, power failure, strike or other difficulty, we may be unable to replace our third party manufacturers in a timely manner.

We may be the subject of costly product liability claims or product recalls, and we may be unable to obtain or maintain insurance adequate to cover potential liabilities.

The risk of product liability is inherent in the development, manufacturing and marketing of human therapeutic products. Regardless of merit or eventual outcome, product liability claims may result in:

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reduced revenues or a total withdrawal of a product from one or more markets;

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delays in, or failure to complete, our clinical trials;

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withdrawal of clinical trial participants;

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decreased demand for our product candidates;

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injury to our reputation;

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litigation costs;

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substantial monetary awards against us; and

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diversion of management or other resources from key aspects of our operations.

Product liability claims could result in an FDA investigation of the safety or efficacy of our products or our marketing programs. An FDA investigation could also potentially lead to a recall of our products or more serious enforcement actions, or limitations on the indications for which our products may be used, or suspension or withdrawal of approval.

We cannot be certain that the coverage limits of the insurance policies or those of our strategic partners will be adequate. We further intend to expand our insurance coverage to include the sale of commercial products if marketing approval is obtained for our product candidates. We may not be able to obtain additional insurance or maintain our existing insurance coverage at a reasonable cost or at all. If we are unable to obtain sufficient insurance at an acceptable cost or if a claim is brought against us, whether fully covered by insurance or not, our business, results of operations and financial condition could be materially adversely affected.

The coverage and reimbursement status of newly approved healthcare drugs is uncertain and failure to obtain adequate coverage and reimbursement could limit our ability to market our products.

Our ability to commercialize any products successfully will depend in part on the extent to which reimbursement will be available from governmental and other third-party payors, both in the United States and in foreign markets. The amount reimbursed for our products may be insufficient to allow them to compete effectively with products that are reimbursed at a higher level. If the price we are able to charge for any product we develop is inadequate in light of our development costs, our profitability would be reduced.

Reimbursement by a governmental and other third-party payor may depend upon a number of factors, including the governmental and other third-party payor’s determination that the use of a product is:

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a covered benefit under its health plan;

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safe, effective and medically necessary;

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appropriate for the specific patient;

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cost-effective; and

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neither experimental nor investigational.

Obtaining reimbursement approval for a product from each third-party and governmental payor is a time consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to obtain reimbursement.

Eligibility for coverage does not imply that any drug product will be reimbursed in all cases or at a rate that allows us to make a profit. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not become permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on payments allowed for lower-cost drugs that are already reimbursed, may be incorporated into existing payments for other products or services and may reflect budgetary constraints and/or Medicare or Medicaid data used to calculate these rates. Net prices for products also may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.

The health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products. There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect reimbursement levels for our future products. In addition, the Centers for Medicare and Medicaid Services frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow Medicare coverage policies and payment limitations in setting their own reimbursement rates and may have sufficient market power to demand significant price reductions.

Foreign governments tend to impose strict price controls, which may adversely affect our future profitability.

In some foreign countries, particularly in the European Union, prescription drug pricing is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidates to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our profitability would be reduced.

Risks Relating to Our Business and Industry

Our failure to attract and retain skilled personnel could impair our product development and commercialization efforts.

Our success is substantially dependent on our continued ability to attract, retain and motivate highly qualified management, scientific and technical personnel and our ability to develop and maintain important relationships with leading institutions, clinicians and scientists. We are highly dependent upon our key management personnel, particularly John V. Talley, our President and Chief Executive Officer, Robert W. Cook, our Senior Vice President and Chief Financial Officer, Dr. Stephane Allard, our Chief Medical Officer and Dr. Dileep Bhagwat, our Senior Vice President, Pharmaceutical Development. We are also dependent on certain scientific and technical personnel. The loss of the services of any member of senior management, or scientific or technical staff may significantly delay or prevent the achievement of product development, commercialization and other business objectives. Messrs. Talley and Cook have entered into employment agreements with us. However, either of them may decide to voluntarily terminate his employment with us. We do not maintain key-man life insurance on any of our employees.

We believe that we will need to recruit additional management and technical personnel. There is currently a shortage of, and intense competition for, skilled executives and employees with relevant scientific and technical expertise, and this shortage may continue. The inability to attract and retain sufficient scientific, technical and managerial personnel could limit or delay our product development efforts, which would reduce our ability to successfully commercialize product candidates and our business.

Our competitors may develop and market drugs that are less expensive, safer, or more effective, which may diminish or eliminate the commercial success of any of our product candidates.

The biotechnology and pharmaceutical industries are highly competitive and characterized by rapid technological change. Because we anticipate that our research approach will integrate many technologies, it may be difficult for us to stay abreast of the rapid changes in technology. If we fail to stay at the forefront of technological change, we will be unable to compete effectively. Our competitors may render our technologies obsolete by advances in existing technological approaches or the development of different approaches by one or more of our current or future competitors.

We will compete with Pfizer and Endo in the treatment of neuropathic pain. There are also many companies, both publicly and privately held, including well-known pharmaceutical companies and academic and other research institutions, engaged in developing pharmaceutical products for the treatment of life-threatening cancers and diseases.

Our competitors may:

•

develop and market product candidates that are less expensive and more effective than our future product candidates;

•

adapt more quickly to new technologies and scientific advances;

•

commercialize competing product candidates before we or our partners can launch any product candidates developed from our product candidates;

•

initiate or withstand substantial price competition more successfully than we can;

•

have greater success in recruiting skilled scientific workers from the limited pool of available talent;

•

more effectively negotiate third-party licenses and strategic alliances; and

•

take advantage of acquisition or other opportunities more readily than we can.

We will compete for market share against fully-integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors, either alone or together with their partners, may develop new product candidates that will compete with our product candidates, as these competitors may operate larger research and development programs or have substantially greater financial resources than us. Our competitors may also have significantly greater experience in:

•

developing drugs;

•

undertaking preclinical testing and human clinical trials;

•

building relationships with key customers and opinion-leading physicians;

•

obtaining and maintaining FDA and other regulatory approvals of drugs;

•

formulating and manufacturing drugs; and

•

launching, marketing and selling drugs.

These and other competitive factors may negatively impact our financial performance.

EpiCept GmbH, our German subsidiary, is subject to various risks associated with its international operations.

Our subsidiary, EpiCept GmbH, operates in Germany, and we face a number of risks associated with its operations, including:

•

difficulties and costs associated in complying with German laws and regulations;

•

changes in the German regulatory environment;

•

increased costs associated with operating in Germany;

•

increased costs and complexities associated with financial reporting; and

•

difficulties in maintaining international operations.

Expenses incurred by our German operations are typically denominated in euros. In addition, EpiCept GmbH has incurred indebtedness that is denominated in euros and requires that interest be paid in euros. As a result, our costs of maintaining and operating our German subsidiary, and the interest payments and costs of repaying its indebtedness, increase if the value of the U.S. dollar relative to the euro declines.

Risks Relating to Intellectual Property

If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products and demand for our products may decline.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our technologies and product candidates as well as successfully defending these patents and trade secrets against third party challenges. We will only be able to protect our intellectual property from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them.

The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. In addition, changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third party patents.

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

•

we might not have been the first to make the inventions covered by each of its pending patent applications and issued patents, and we could lose our patent rights as a result;

•

we might not have been the first to file patent applications for these inventions or our patent applications may not have been timely filed, and we could lose our patent rights as a result;

•

others may independently develop similar or alternative technologies or duplicate any of our technologies;

•

it is possible that none of our pending patent applications will result in issued patents;

•

our issued patents may not provide a basis for commercially viable drugs or therapies, may not provide us with any protection from unauthorized use of our intellectual property by third parties, and may not provide us with any competitive advantages;

•

our patent applications or patents may be subject to interference, opposition or similar administrative proceedings;

•

we may not develop additional proprietary technologies that are patentable; or

•

the patents of others may have an adverse effect on our business.

Moreover, the issuance of a patent is not conclusive as to its validity or enforceability and it is uncertain how much protection, if any, will be afforded by our patents if we attempt to enforce them and they are challenged in court or in other proceedings, such as oppositions, which may be brought in U.S. or foreign jurisdictions to challenge the validity of a patent. A third party may challenge the validity or enforceability of a patent after its issuance by the U.S. Patent and Trademark Office, or USPTO.

The defense and prosecution of intellectual property suits, interferences, oppositions and related legal and administrative proceedings in the United States are costly, time consuming to pursue and result in diversion of resources. The outcome of these proceedings is uncertain and could significantly harm our business.

We will also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We will use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific partners and other advisors may unintentionally or willfully disclose its confidential information to competitors. Enforcing a claim that a third party improperly obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

If we are not able to defend the patent protection position of our technologies and product candidates, then we will not be able to exclude competitors from marketing product candidates that directly compete with our product candidates, and we may not generate enough revenue from our product candidates to justify the cost of their development and to achieve or maintain profitability.

If we are sued for infringing intellectual property rights of third parties, such litigation will be costly and time consuming, and an unfavorable outcome could increase our costs or have a negative impact on our business.

Our ability to commercialize our products depends on our ability to sell our products without infringing the proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending applications, which are owned by third parties, exist with respect to the therapeutics utilized in our product candidates and topical delivery mechanisms. Because we are utilizing existing therapeutics, we will continue to need to ensure that we can utilize these therapeutics without infringing existing patent rights. Accordingly, we have reviewed related patents known to us and, in some instances, licensed related patented technologies. In addition, because patent applications can take several years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that the combined organization’s product candidates may infringe. There could also be existing patents of which we are not aware that our product candidates may inadvertently infringe.

We cannot assure you that any of our product candidates does not infringe the intellectual property of others. There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a third party claims that we infringe on their technology, we could face a number of issues that could increase its costs or have a negative impact on its business, including:

•

infringement and other intellectual property claims which, with or without merit, can be costly and time consuming to litigate and can delay the regulatory approval process and divert management’s attention from our core business strategy;

•

substantial damages for past infringement, which we may have to pay if a court determines that our products infringes a competitor’s patent;

•

an injunction prohibiting us from selling or licensing our product unless the patent holder licenses the patent to us, which the holder is not required to do; and

•

if a license is available from a patent holder, we may have to pay substantial royalties or grant cross licenses to our patents.

We may be subject to damages resulting from claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

Many of our employees were previously employed at other biotechnology or pharmaceutical companies, including competitors or potential competitors. We may be subject to claims that we or these employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary claims, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain product candidates, which could severely harm our business. Litigation could result in substantial costs and be a distraction to management.

Risks Relating to our Common Stock

Our common stock may be delisted from The Nasdaq Capital Market or the Nasdaq OMX Stockholm Exchange, which may make it more difficult for you to sell your shares.

In October 2010, we received a letter from the Nasdaq Listing Qualifications Department stating that we are not in compliance with the continued listing requirements of The Nasdaq Capital Market because the bid price of our common stock had closed below the minimum $1.00 per share requirement for 30 consecutive business days. We have been provided a period of 180 calendar days, or until April 4, 2011, to regain compliance with the minimum bid price rule. If at any time before April 4, 2011, the bid price of our common stock closes at $1.00 per share or higher for a period determined by Nasdaq (which shall be a minimum of 10 consecutive business days), Nasdaq will provide us with written notification that we are in compliance with the rule.

In the event that we do not regain compliance with the minimum bid price rule by April 4, 2011, Nasdaq will determine whether we meet the initial listing criteria, with the exception of bid price, for The Nasdaq Capital Market and, if we do, we will be granted an additional compliance period of 180 calendar days.

In the event that we are not eligible for the minimum bid price additional compliance period, we will have the right to appeal a determination to delist our common stock. Our common stock would remain listed on The Nasdaq Capital Market until the completion of the appeal process.

Delisting of our common stock by The Nasdaq Capital Market may result in the delisting of our common stock on the Nasdaq OMX Stockholm Exchange in Sweden and the delisting of our common stock on The Nasdaq Capital Market or the Nasdaq OMX Stockholm Exchange would adversely affect the market price and liquidity of our common stock and warrants, your ability to sell your shares of our common stock and our ability to raise capital.

We expect that our stock price will fluctuate significantly due to external factors, which could cause the value of your investment to decline.

Securities markets worldwide have experienced, and are likely to continue to experience, significant price and volume fluctuations. This market volatility, as well as general economic, market or political conditions, could reduce the market price of our common stock regardless of our operating performance.

Since January 30, 2007, our common stock trades on The Nasdaq Capital Market and on the Nasdaq OMX Stockholm Exchange. From January 5, 2006 through January 29, 2007, our common stock traded on The Nasdaq National Market. Prior to January 4, 2006, our common stock did not trade on an exchange. Sales of substantial amounts of our common stock in the public market through equity financing or otherwise could adversely affect the prevailing market prices of the common stock and our ability to raise equity capital in the future. In particular, as of March 30, 2011 we have outstanding warrants to purchase approximately 33.4 million shares of our common stock, and the market price of our common stock could decline as a result of exercises or sales by our existing warrant holders in the market or the perception that these exercises or sales could occur. These exercises or sales might also make it more difficult for us to sell equity securities at a time and price that we deem appropriate.

If securities or industry analysts do not publish research or reports about us, if they change their recommendations regarding our stock adversely or if our operating results do not meet their expectations, our stock price and trading volume could decline.

The trading market for our common stock is influenced by the research and reports that industry or securities analysts publish about us. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. Moreover, if one or more of the analysts who covers us downgrades our stock or if our operating results do not meet their expectations, our stock price could decline.

Future sales of common stock may cause our stock price to fall.

As of March 30, 2011, we have outstanding and exercisable warrants to purchase approximately 17.0 million shares of our common stock with exercise prices ranging from $0.75 — $2.08. We also have a significant number of warrants outstanding with exercise prices ranging from $2.58 — $5.64 that are currently exercisable. The market price of our common stock could decline as a result of exercises or sales by our existing warrant holders and stockholders in the market or the perception that these exercises or sales could occur. These sales might also make it more difficult for us to sell equity securities or convertible debt securities at a time and price that we deem appropriate.

Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for you to change management.

Provisions of our certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. This is because these provisions may prevent or frustrate attempts by stockholders to replace or remove our management. These provisions include:

•

a classified board of directors;

•

a prohibition on stockholder action through written consent;

•

a requirement that special meetings of stockholders be called only by the board of directors or a committee duly designated by the board of directors whose powers and authorities include the power to call such special meetings;

•

advance notice requirements for stockholder proposals and nominations; and

•

the authority of the board of directors to issue preferred stock with such terms as the board of directors may determine.

In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person that together with its affiliates owns or within the last three years has owned 15% of voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of us.

As a result of these provisions in our charter documents and Delaware law, the price investors may be willing to pay in the future for shares of our common stock may be limited.

We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.

We have never paid cash dividends on any of our classes of capital stock to date, and we intend to retain our future earnings, if any, to fund the development and growth of our business. In addition, the terms of existing or any future debt may preclude us from paying these dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

The requirements of being a public company may strain our resources and distract management.

As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the listing requirements of The Nasdaq Capital Market and the Nasdaq OMX Stockholm Exchange. The obligations of being a public company require significant additional expenditures and place additional demands on our management as we comply with the reporting requirements of a public company. We may need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge.

ITEM 1B.		UNRESOLVED STAFF COMMENTS

We have no written comments regarding our periodic or current reports from the staff of the Securities and Exchange Commission that were issued 180 days or more preceding the end of our 2010 fiscal year that remain unresolved.

ITEM 2.		PROPERTIES

We lease approximately 10,000 square feet located at 777 Old Saw Mill River Road, Tarrytown, NY; the lease expires in February 2012. We also lease approximately 3,000 square feet in Munich, Germany; the lease expires in July 2014. We currently lease approximately 23,500 rentable square feet of laboratory and office space in San Diego, California that we are attempting to sublease. We believe that our existing facilities will be adequate to accommodate our business needs for the foreseeable future.

ITEM 3.		LEGAL PROCEEDINGS

None.

ITEM 4.		REMOVED AND RESERVED

PART II

ITEM 5.		MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Price Range of Common Stock

Our common stock is traded on both The Nasdaq Capital Market and the Nasdaq OMX Stockholm Exchange under the symbol “EPCT.” The following table sets forth the range of high and low sales prices per share for the common stock as reported on The Nasdaq Capital Market during the periods indicated. For ease of comparison, all of the prices in the following table have been adjusted to reflect the 1:3 reverse split of our common stock, which was effective for the start of trading on January 15, 2010, as if such reverse split had been in effect during the periods indicated. Prior to January 4, 2006, all of our common stock, par value $.0001 per share, was privately held. We have never declared or paid dividends on our common stock and we do not anticipate paying any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business.

		Price Range
		High				Low
For Year Ended December 31, 2010
First Quarter		$	2.73			$	1.74
Second Quarter			2.12				0.95
Third Quarter			1.15				0.52
Fourth Quarter			1.09				0.33

		Price Range
		High				Low
For Year Ended December 31, 2009
First Quarter		$	2.82			$	1.26
Second Quarter			3.75				1.29
Third Quarter			3.06				1.68
Fourth Quarter			2.73				1.68

The high and low sales prices for the Common Stock during the first quarter of 2011 (through March 28, 2011) were $0.93 and $0.57 respectively. The closing price on March 28, 2011 was $0.69.

Performance Graph

The following graph and table compare the cumulative total return of our common stock, the Nasdaq Composite Index and the Nasdaq Biotechnology Index, as described below, for the period beginning January 4, 2006 (the date we became a public company) and ending December 31, 2010, assuming an initial investment of $100 and the reinvestment of any dividends. We obtained the information reflected in the graph and table from independent sources we believe to be reliable, but we have not independently verified the information.

ASSUMES $100 INVESTED ON JAN. 06, 2006
ASSUMES DIVIDEND REINVESTED
FISCAL YEAR ENDING DEC. 31, 2010

		Period Ending
Company/Market/Peer Group		1/5/2006				12/31/2006				12/31/2007				12/31/2008				12/31/2009				12/31/2010
EpiCept Corporation		$	100.00			$	16.82			$	14.94			$	7.53			$	6.82			$	3.41
NASDAQ Composite		$	100.00			$	109.92			$	121.51			$	72.88			$	105.90			$	124.98
NASDAQ Biotechnology		$	100.00			$	98.48			$	103.05			$	90.37			$	104.80			$	120.78

Performance Graph and related information shall not be deemed “soliciting material” or to be “filed” with the Securities and Exchange Commission, nor shall such information be incorporated by reference into any future filing under the Securities Act or Exchange Act, each as amended, except to the extent that we specifically incorporate it by reference into such filing.

ITEM 6.		SELECTED FINANCIAL DATA

		Years Ended December 31,
		2010				2009				2008				2007				2006(1)
		(Dollars in thousands, except share and per share data)
Consolidated Statements of Operations Data:
Revenue		$	994			$	414			$	265			$	327			$	2,095
Costs and expenses:
Costs of goods sold			997				—				—				—				—
General and administrative			7,244				7,548				9,599				11,759				14,242
Research and development			8,127				11,603				12,623				15,312				15,675
Acquired in-process research and development			—				—				—				—				33,362
Total costs and expenses			16,368				19,151				22,222				27,071				63,279
Loss from operations			(15,374	)			(18,737	)			(21,957	)			(26,744	)			(61,184	)
Other expense, net			(159	)			(20,073	)(5)			(3,422	)			(1,945	)			(4,269	)
Loss before (expense)/benefit for income taxes			(15,533	)			(38,810	)			(25,379	)			(28,689	)			(65,453	)
Income tax (expense)/benefit			(4	)			(4	)			(3	)			(4	)			—
Net loss			(15,537	)			(38,814	)			(25,382	)			(28,693	)			(65,453	)
Deemed dividend and redeemable convertible preferred stock dividends			—				—				—				—				(8,963	)
Loss attributable to common stockholders		$	(15,537	)		$	(38,814	)		$	(25,382	)		$	(28,693	)		$	(74,416	)
Basic and diluted loss per common share(2)		$	(0.32	)		$	(0.97	)		$	(1.23	)		$	(2.37	)		$	(9.21	)
Weighted average shares outstanding(2)			47,853,560				40,139,299				20,685,710				12,129,258				8,077,625

		As of December 31,
		2010				2009				2008				2007				2006(1)
		(Dollars in thousands)
Consolidated Balance Sheet Data:
Cash and cash equivalents		$	2,435			$	5,142			$	790			$	4,943			$	14,097
Working capital (deficit)			(1,887	)			1,407				(8,535	)			(8,208	)(3)			(4,481	)(3)
Total assets			4,689				7,514				2,271				7,398				18,426
Long-term debt			448				967				277				375				447
Accumulated deficit			(250,582	)			(235,045	)			(196,231	)			(170,849	)			(142,156	)(4)
Total stockholders’ deficit			(14,135	)			(9,079	)			(17,730	)			(14,177	)			(9,373	)

ITEM 7.		MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this report. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, including those set forth under the section entitled “Risk Factors” and elsewhere in this report, our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

We are a specialty pharmaceutical company focused on the clinical development and commercialization of pharmaceutical products for the treatment of cancer and pain. We focus our clinical development efforts on innovative cancer therapies and topically delivered analgesics targeting peripheral nerve receptors. Our lead product is Ceplene^®, which when used concomitantly with low-dose interleukin-2, or IL-2, is intended as remission maintenance therapy in the treatment of acute myeloid leukemia, or AML, for adult patients who are in their first complete remission. In addition to Ceplene^®, we have two other oncology compounds and a late-stage pain product candidate for the treatment of peripheral neuropathies in clinical development. We believe this portfolio of oncology and pain management product candidates lessens our reliance on the success of any single product or product candidate.

In October 2008, the European Commission issued a formal marketing authorization for Ceplene^® in the European Union, or EU. In January 2010 we completed an agreement with Meda AB of Sweden to market and sell Ceplene^® in Europe and certain Pacific Rim countries. The commercial launch of Ceplene^® commenced in the United Kingdom in April 2010 and launches continue in other European countries. In December 2010, Ceplene^® was approved for marketing in Israel. Megapharm Ltd. is our partner in Israel and upon Ministry of Health approval of labeling and other technical matters we expect to launch Ceplene^® in the first half of 2011.

In November 2009, Health Canada screened and accepted for review a New Drug Submission (“NDS”) for Ceplene^® for remission maintenance treatment of AML in Canada. During the third quarter of 2010, our appeal of a decision by Health Canada not to provide data protection for Ceplene^® was denied by a federal court in Canada. Lack of data protection in Canada for an innovative drug such as Ceplene^® eliminates any right to sales exclusivity by us and enables competition to seek approval to sell generic equivalents immediately. In November 2010, we appealed the court’s decision and withdrew our New Drug Submission until the appeals process is completed. We retain the right to re-file the application at any time over the next five years without prejudice.

In June 2010, we filed a New Drug Application, or NDA, with the United States Food and Drug Administration, or FDA for Ceplene^® in the same indication. In August 2010, we received a refusal to file letter from the FDA. In the FDA’s preliminary review of the Ceplene^® NDA, the FDA concluded that the application did not establish Ceplene’s therapeutic contribution in its combination with IL-2, and recommended that an additional pivotal trial assessing Ceplene’s contribution and using overall survival as a primary endpoint be conducted. In October 2010, we reached an agreement with the FDA for a two-arm, randomized, open-label trial that will compare the efficacy of Ceplene^® plus low-dose IL-2 to standard of care in this indication. Based on FDA guidance, the primary endpoint of the trial will be overall patient survival. Our previous Phase III trial demonstrated a statistically significant prolongation of the primary endpoint of leukemia-free survival and extended overall survival by more than one year in patients in their first complete remission. As a next step, we will submit a detailed Phase III protocol. The FDA, via the Special Protocol Assessment (SPA) procedure, will provide guidance on specific sections of the protocol including the adaptive design with prospectively defined rules for sample size selection for both futility and expected success. We also recently filed an application with the FDA to grant Ceplene^® fast track status. In addition to other benefits, if granted, this should permit an expedited review of the Ceplene^® New Drug Application (NDA) once it is filed.

Our other oncology compounds include crolibulin^TM, a novel small molecule vascular disruption agent, or VDA, and apoptosis inducer for the treatment of patients with solid tumors. In December 2010, the National Cancer Institute (NCI) initiated a Phase II trial with crolibulin^TM. The trial will assess the drug’s efficacy and safety in combination with cisplatin in patients with anaplastic thyroid cancer (ATC). Azixa^TM, an apoptosis inducer with VDA activity licensed by us to Myrexis, Inc., or Myrexis, as part of an exclusive, worldwide development and commercialization agreement, is currently in Phase II clinical trials in patients with primary glioblastoma, and cancer that has metastasized to the brain. In December 2010, Myrexis began a Phase IIb clinical study of Azixa^TM to treat glioblastoma multiforme, an aggressive brain tumor, in order to evaluate Azixa^TM combination therapy as a first-line GBM treatment. The study will enroll as many as 120 patients in the U.S. and India. Azixa^TM has received orphan drug status in the United States for the treatment of glioblastoma.

Our late-stage pain product candidate, EpiCept^TM NP-1 cream, which we refer to as NP-1, is a prescription topical analgesic cream designed to provide effective long-term relief of pain associated with peripheral neuropathies. In February 2011, we presented data from our Phase IIb trial for EpiCept™ NP-1 in chemotherapy-induced peripheral neuropathy (CPN) which is being conducted by National Cancer Institute (NCI). CPN may affect 50% of women undergoing treatment for breast cancer. A common therapeutic agent for the treatment of advanced breast cancer is paclitaxel, and as many as 80% of the patients with advanced breast cancer experience some signs and symptoms of CPN, such as burning, tingling pain associated sometimes with mild muscular weakness, after high dose paclitaxel administration. The multi-center, double-blind, randomized, placebo-controlled study was conducted within a network of approximately 25 sites under the direction of the NCI funded Community Clinical Oncology Program (CCOP). More than 460 cancer survivors suffering from painful CPN were enrolled in the six-week study. The results of the trial in the intent to treat (ITT) population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p<0.001), which was the trial’s primary endpoint. Additionally, a pre-specified subgroup of the ITT population, those patients who previously received taxane chemotherapy, also showed a statistically significant reduction in average daily neuropathy intensity scores (p=0.034). This subgroup constituted more than 50% of the ITT population. Secondary efficacy endpoints confirmed the superiority of NP-1 vs. placebo. Furthermore, the safety profile of NP-1 was comparable to placebo.

Ceplene^® has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission. None of our other drug candidates has received FDA or foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory agencies must conclude that our clinical data and that of our collaborators establish the safety and efficacy of our drug candidates. Furthermore, our strategy includes entering into collaborative arrangements with third parties to participate in the clinical development and commercialization of our products. In the event that third parties have control over the preclinical development or clinical trial process for a product candidate, the estimated completion date would largely be under control of that third party rather than under our control. We cannot forecast with any degree of certainty which of our drug candidates will be subject to future collaborations or how such arrangements would affect our development plan or capital requirements.

We are subject to a number of risks associated with companies in the specialty pharmaceutical industry. Principal among these are risks associated with our ability to obtain regulatory approval for our product candidates, our ability to adequately fund our operations, dependence on collaborative arrangements, the development by us or our competitors of new technological innovations, dependence on key personnel, protection of proprietary technology and compliance with the FDA and other governmental regulations. We have yet to generate significant product revenues from any of our product candidates. We have financed our operations primarily through the proceeds from the sale of common stock, warrants, debt instruments, cash proceeds from collaborative relationships and investment income earned on cash balances and short-term investments.

We have prepared our consolidated financial statements under the assumption that we are a going concern. We have devoted substantially all of our cash resources to research and development programs and selling, general and administrative expenses, and to date we have not generated any significant revenues from the sale of products. Since inception, we have incurred significant net losses each year. As a result, we have an accumulated deficit of $250.6 million as of December 31, 2010. Our recurring losses from operations and the accumulated deficit raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Our losses have resulted principally from costs incurred in connection with our development activities and from selling, general and administrative expenses. Even if we succeed in developing and commercializing one or more of our product candidates, we may never become profitable. We expect to continue to incur significant expenses over the next several years as we:

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apply for marketing approval of Ceplene® in the U.S., Canada, and other countries;

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continue to conduct clinical trials for our product candidates;

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seek regulatory approvals for our product candidates;

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develop, formulate, and commercialize our product candidates;

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implement additional internal systems and develop new infrastructure;

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acquire or in-licenses additional products or technologies or expand the use of our technologies;

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maintain, defend and expand the scope of our intellectual property; and

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hire additional personnel.

Cash at December 31, 2010, plus $4.6 million of cash received in March 2011 from the issuance of approximately 7.1 million shares of our common stock and warrants to purchase 5.3 million shares of our common stock and $7.1 million of cash received in February 2011 from the issuance of approximately 8.9 million shares of our common stock and warrants to purchase 3.6 million shares of our common stock will be sufficient to fund our operations and meet our debt service requirements into 2012. To conserve cash, we may delay or cancel some of our planned development activities that are not related to Ceplene^® during 2011.

We have two wholly-owned subsidiaries, Maxim Pharmaceuticals, Inc., which is currently inactive, and EpiCept GmbH, based in Munich, Germany, which is engaged in commercial activities on our behalf.

Reverse Split of Common Stock

On January 14, 2010, we effected a previously authorized 1-for-3 reverse stock split of our common stock. The reverse stock split took effect at the start of trading on January 15, 2010 on a 1-for-3 split-adjusted basis. All prior periods have been retroactively adjusted to reflect the reverse stock split.

The Nasdaq Capital Market Listing

On February 2, 2010, Nasdaq Listing Qualifications Department notified us that we have regained compliance with the minimum bid price requirement in Listing Rule 5550(a)(2) and met the requirements of the Nasdaq Listing Qualification Panel (the “Panel”) decision dated November 2, 2009. Accordingly, the Panel has determined to continue the listing of our common stock on The Nasdaq Stock Market. The Panel had previously determined to continue our listing subject to the condition that, on or before February 1, 2010, we evidence a closing bid price of $1.00 per share or more for at least the ten prior consecutive trading days. On January 29, 2010, our closing bid price was $2.37 per share, the tenth consecutive day it had exceeded the $1.00 per share threshold. Accordingly, we satisfied the Panel’s condition and the delisting proceeding was closed.

On October 6, 2010, we received two letters from the Nasdaq Listing Qualifications Department. One letter states that we are not in compliance with the continued listing requirements of The Nasdaq Capital Market because the bid price of our common stock closed below the minimum $1.00 per share requirement for 30 consecutive business days (pursuant to Listing Rule 5550(a)(2)). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have been provided a period of 180 calendar days, or until April 4, 2011, to regain compliance with the minimum bid price rule. If at any time before April 4, 2011, the bid price of our common stock closes at $1.00 per share or higher for a period determined by Nasdaq (which shall be a minimum of 10 consecutive business days), Nasdaq will provide written notification to us that we comply with the Rule.

The second letter from Nasdaq stated that we were not in compliance with the continued listing requirements of The Nasdaq Capital Market because the market value of our listed securities fell below $35 million for 30 consecutive business days (pursuant to Listing Rule 5550(b)(2)). Pursuant to Nasdaq Listing Rule 5810(c)(3)(C), we were provided a period of 180 calendar days, or until April 4, 2011, to regain compliance with the market value standard. If at any time before April 4, 2011, the market value of our listed securities closed at $35 million or more for a period determined by Nasdaq (which shall be a minimum of 10 consecutive business days), Nasdaq was to provide written notification to us that we comply with the Rule. On December 29, 2010, the Company received notification from the Nasdaq Listing Qualifications Department that it had regained compliance with the market value standard pursuant to Listing Rule 5550(b)(2) and this matter is now closed.

We remain out of compliance with the continued listing requirements of The Nasdaq Capital Market because the bid price of our common stock remains below the minimum $1.00 per share requirement (pursuant to Listing Rule 5550(a)(2)). In the event that we do not regain compliance with the minimum bid price rule by April 4, 2011, Nasdaq will determine whether we meet the initial listing criteria, with the exception of bid price, for The Nasdaq Capital Market and, if we do, we will be granted an additional compliance period of 180 calendar days. In the event that the Company is not eligible for the minimum bid price additional compliance period the Company will have the right to appeal a determination to delist the Company’s securities. The Company’s securities would remain listed on The Nasdaq Capital Market until the completion of the appeal process.

Recent Events

In March 2011, we sold approximately 7.1 million shares of our common stock and warrants to purchase 5.3 million shares of our common stock for gross proceeds of $4.6 million, $4.3 million net of $0.3 million in transaction costs.

In February 2011, we sold approximately 8.9 million shares of our common stock and warrants to purchase 3.6 million shares of our common stock for gross proceeds of $7.1 million, $6.6 million net of $0.5 million in transaction costs.

In February 2011, we presented data from our Phase IIb trial for EpiCept™ NP-1 in chemotherapy-induced peripheral neuropathy, or CPN, which is being conducted by National Cancer Institute, or NCI. CPN may affect 50% of women undergoing treatment for breast cancer. A common therapeutic agent for the treatment of advanced breast cancer is paclitaxel, and as many as 80% of the patients with advanced breast cancer experience some signs and symptoms of CPN, such as burning, tingling pain associated sometimes with mild muscular weakness, after high dose paclitaxel administration. The multi-center, double-blind, randomized, placebo-controlled study was conducted within a network of approximately 25 sites under the direction of the NCI funded Community Clinical Oncology Program, or CCOP. More than 460 cancer survivors suffering from painful CPN were enrolled in the six-week study. The results of the trial in the intent to treat, or ITT, population demonstrated that the change in average daily neuropathy intensity scores in the NP-1 group achieved a statistically significant reduction in CPN intensity versus placebo (p<0.001), which was the trial’s primary endpoint. Additionally, a pre-specified subgroup of the ITT population, those patients who previously received taxane chemotherapy, also showed a statistically significant reduction in average daily neuropathy intensity scores (p=0.034). This subgroup constituted more than 50% of the ITT population. Secondary efficacy endpoints confirmed the superiority of NP-1 vs. placebo. Furthermore, the safety profile of NP-1 was comparable to placebo.

License Agreements

In January 2010, we entered into an exclusive commercialization agreement for Ceplene^® with Meda AB, a leading international specialty pharmaceutical company based in Stockholm, Sweden. Under the terms of the agreement, we granted Meda the right to market Ceplene^® in Europe and several other countries including Japan, China, and Australia. We received a $3 million fee on signing and received an additional $2 million upon the first commercial launch of Ceplene in a major European market, which have been deferred and are being recognized as revenue ratably over the life of the commercialization agreement with Meda. Additional potential payments include a $5 million payment upon achievement of a regulatory milestone and up to $30 million in sales-based milestones that commence upon attainment of at least $50 million in annual sales. We will also receive an escalating percentage royalty on net sales in the covered territories ranging from the low teens to the low twenties and we will be responsible for Ceplene’s commercial supply. The initial term of this agreement is ten years and is subject to automatic two year extensions at Meda’s option. The agreement can be terminated at any time by Meda upon six months prior written notice. The agreement can also be terminated by mutual agreement or for cause.

In connection with our merger with Maxim Pharmaceuticals on January 4, 2006, we acquired a license agreement with Myrexis under which we licensed the MX90745 series of caspase-inducer anti-cancer compounds to Myrexis. Myrexis has initiated clinical trials for Azixa^TM, a MX90745 series compound, for the treatment of brain cancer. Under the terms of the agreement, Maxim granted to Myrexis a research license to develop and commercialize any drug candidates from the series of compounds during the Research Term (as defined in the agreement) with a non-exclusive, worldwide, royalty-free license, without the right to sublicense the technology. Myrexis is responsible for the worldwide development and commercialization of any drug candidates from the series of compounds. Maxim also granted to Myrexis a worldwide royalty bearing development and commercialization license with the right to sublicense the technology. The agreement requires that Myrexis make licensing, research and milestone payments to us totaling up to $27 million, of which $3.0 million was paid and recognized as revenue by Maxim prior to the merger on January 4, 2006, assuming the successful commercialization of the compound for the treatment of cancer, as well as pay an escalating mid to high single digit percentage royalty on product sales. In March 2008, we received a milestone payment of $1.0 million following dosing of the first patient in a Phase II registration sized clinical trial, which has been deferred and is being recognized as revenue ratably over the life of the last to expire patent that expires in July 2024. As of December 31, 2010, we recorded inception to date revenue of $0.2 million related to this license agreement.

In December 2006, we entered into a license agreement with DURECT, pursuant to which we granted DURECT the exclusive worldwide rights to certain of our intellectual property for a transdermal patch containing bupivacaine for the treatment of back pain. Under the terms of the agreement, we received a $1.0 million payment. In September 2008, we amended our license agreement with DURECT. Under the terms of the amended agreement, we granted DURECT royalty-free, fully paid up, perpetual and irrevocable rights to the intellectual property licensed as part of the original agreement in exchange for a cash payment of $2.25 million from DURECT. As of December 31, 2010, we recorded inception to date revenue of $0.8 million related to this license agreement.

In December 2003, we entered into a license agreement with Endo under which we granted Endo (and its affiliates) the exclusive (including as to us and our affiliates) worldwide right to commercialize LidoPAIN BP. We also granted Endo worldwide rights to certain of our other patents used by Endo in the development of certain Endo products, including Lidoderm^®, Endo’s topical lidocaine-containing patch, for the treatment of chronic lower back pain. Upon the execution of the Endo agreement, we received a non-refundable payment of $7.5 million, which has been deferred and is being recognized as revenue on the proportional performance method. We may receive payments of up to $52.5 million upon the achievement of various milestones relating to product development and regulatory approval for both our LidoPAIN BP product candidate and licensed Endo product candidates, including Lidoderm^®, so long as, in the case of Endo’s product candidate, our patents provide protection thereof. We are also entitled to receive royalties from Endo based on the net sales of LidoPAIN BP. These royalties are payable until generic equivalents to the LidoPAIN BP product are available or until expiration of the patents covering LidoPAIN BP, whichever is sooner. We are also eligible to receive milestone payments from Endo of up to approximately $30.0 million upon the achievement of specified net sales milestones for licensed Endo products, including Lidoderm^®, so long as our patents provide protection thereof. The future amount of milestone payments we are eligible to receive under the Endo agreement is $82.5 million. As of December 31, 2010 we recorded inception to date revenue related to this license agreement in the amount of $1.7 million of which $14,000 was recorded as revenue during 2010.

Under the terms of the license agreement, we are responsible for continuing and completing the development of LidoPAIN BP, including the conduct of all clinical trials and the supply of the clinical products necessary for those trials and the preparation and submission of the NDA in order to obtain regulatory approval for LidoPAIN BP. Endo remains responsible for continuing and completing the development of Lidoderm^® for the treatment of chronic lower back pain, including the conduct of all clinical trials and the supply of the clinical products necessary for those trials. No progress in the development of LidoPAIN BP or Lidoderm with respect to back pain has been reported. Accordingly, we do not expect to receive any further cash compensation pursuant to this license agreement.

Off Balance Sheet Arrangements

We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. Therefore, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships. We do not have relationships or transactions with persons or entities that derive benefits from their non-independent relationship with us or our related parties.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires that we make estimates and judgments affecting the reported amounts of assets, liabilities and expenses and related disclosure of contingent assets and liabilities. We review our estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our consolidated financial statements included in this annual report, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period and stock-based compensation. Actual results could differ from those estimates.

Revenue Recognition

We recognize revenue relating to our collaboration agreements in accordance with the SEC Staff Accounting Bulletin (“SAB”) 104, Revenue Recognition, and FASB Accounting Standards Codification (“ASC”) 605-25, “Revenue Recognition — Multiple Element Arrangements” (“ASC 605-25”). Revenue under collaborative arrangements may result from license fees, milestone payments, research and development payments and royalties.

Our application of these standards involves subjective determinations and requires management to make judgments about value of the individual elements and whether they are separable from the other aspects of the contractual relationship. We evaluate our collaboration agreements to determine units of accounting for revenue recognition purposes. For collaborations containing a single unit of accounting, we recognize revenue when the fee is fixed or determinable, collectibility is assured and the contractual obligations have occurred or been rendered. For collaborations involving multiple elements, our application requires management to make judgments about value of the individual elements and whether they are separable from the other aspects of the contractual relationship. To date, we have determined that our upfront non-refundable license fees cannot be separated from our ongoing collaborative research and development activities to the extent such activities are required under the agreement and, accordingly, do not treat them as a separate element. We recognize revenue from non-refundable, up-front licenses and related payments, not specifically tied to a separate earnings process, either on the proportional performance method with respect to our license with Endo, or ratably over either the development period or the later of (1) the conclusion of the royalty term on a jurisdiction by jurisdiction basis; and (2) the expiration of the last EpiCept licensed patent as we do with respect to our license with DURECT, Myrexis and GNI, Ltd., or GNI.

Proportional performance is measured based on costs incurred compared to total estimated costs over the development period which approximates the proportion of the value of the services provided compared to the total estimated value over the development period. The proportional performance method currently results in revenue recognition at a slower pace than the ratable method as many of our costs are incurred in the latter stages of the development period. We periodically review our estimates of cost and the length of the development period and, to the extent such estimates change, the impact of the change is recorded at that time. During each of the years 2010, 2009 and 2008 we increased the estimated development period by an additional twelve months to reflect additional time required to obtain clinical data from our partner.

We will recognize milestone payments as revenue upon achievement of the milestone only if (1) it represents a separate unit of accounting as defined in ASC 605-25; (2) the milestone payments are nonrefundable; (3) substantive effort is involved in achieving the milestone; and (4) the amount of the milestone is reasonable in relation to the effort expended or the risk associated with the achievement of the milestone. If any of these conditions are not met, we will recognize milestones as revenue in accordance with our accounting policy in effect for the respective contract. At the time of a milestone payment receipt, we will recognize revenue based upon the portion of the development services that are completed to date and defer the remaining portion and recognize it over the remainder of the development services on the proportional or ratable method, whichever is applicable. When payments are specifically tied to a separate earnings process, revenue will be recognized when the specific performance obligation associated with the payment has been satisfied. Deferred revenue represents the excess of cash received compared to revenue recognized to date under licensing agreements.

We have chosen early adoption of the milestone method of revenue recognition as defined in ASC 605-28, “Revenue Recognition — Milestone Method” on a prospective basis as of January 1, 2010. Under this method of revenue recognition, we will recognize into revenue research-related milestone payments for which there is substantial uncertainty at the date the arrangement is entered into that the event will be achieved, when that event can only be achieved based in whole or in part on our performance or a specific outcome resulting from our performance and, if achieved, would result in additional payments being due to us. This accounting will be applicable to research milestones under the license agreement entered into with Meda AB in 2010.

The Meda AB agreement entitles us to a $3.0 million upfront payment, a $2.0 million payment upon launch of Ceplene^® in a major country in the European Union, and milestone payments and royalties on sales of Ceplene^®. The $3.0 million upfront payment received in the first quarter of 2010 and the $2.0 million payment upon launch of Ceplene^® in a major country in the European Union received in the second quarter of 2010 have been deferred and are being recognized as revenue ratably over the life of the commercialization agreement with Meda AB.

Royalty revenue is recognized in the period the sales occur, provided that the royalty amounts are fixed or determinable, collection of the related receivable is reasonably assured and we have no remaining performance obligations under the arrangement providing for the royalty. If royalties are received when we have remaining performance obligations, they would be attributed to the services being provided under the arrangement and, therefore, recognized as such obligations are performed under either the proportionate performance or straight-line methods, as applicable.

Royalty Expense

Upon receipt of marketing approval and commencement of commercial sales, some of which may not occur for several years, we will owe royalties to licensors of certain patents generally based upon net sales of the respective products. Under a license agreement with respect to NP-1, we are obligated to pay royalties based on annual net sales derived from the products incorporating the licensed technology. Under a license agreement with respect to crolibulin^TM, we are required to provide a portion of any sublicensing payments we receive if we relicense the series of compounds or make milestone payments, assuming the successful commercialization of the compound by us for the treatment of a cancer indication, as well as pay a royalty on product sales. Under a royalty agreement with respect to Ceplene^®, we are obligated to pay royalties based on annual net sales derived from the products incorporating the licensed technology. In each case, our royalty obligation ends the later of (1) the conclusion of the royalty term on a jurisdiction by jurisdiction basis; and (2) the expiration of the last EpiCept licensed patent.

Stock-Based Compensation

We record stock-based compensation expense at fair value in accordance with the Financial Accounting Standards Board, or FASB, issued ASC 718-10, “Compensation — Stock Compensation” (“ASC 718-10”). We utilize the Black-Scholes valuation method to recognize compensation expense over the vesting period. Certain assumptions need to be made with respect to utilizing the Black-Scholes valuation model, including the expected life, volatility, risk-free interest rate and anticipated forfeiture of the stock options. The expected life of the stock options was calculated using the method allowed by the provisions of ASC 718-10. In accordance with ASC 718-10, the simplified method for “plain vanilla” options may be used where the expected term is equal to the vesting term plus the original contract term divided by two. The risk-free interest rate is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the expected life of the options. Estimates of pre-vesting option forfeitures are based on our experience. We will adjust our estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods.

We account for stock-based transactions with non-employees in which services are received in exchange for the equity instruments based upon the fair value of the equity instruments issued, in accordance with ASC 718-10 and ASC 505-50, “Equity-Based Payments to Non-Employees.” The two factors that most affect charges or credits to operations related to stock-based compensation are the estimated fair market value of the common stock underlying stock options for which stock-based compensation is recorded and the estimated volatility of such fair market value. The value of such options is periodically remeasured and income or expense is recognized during the vesting terms.

Accounting for stock-based compensation granted by us requires fair value estimates of the equity instrument granted or sold. If our estimate of the fair value of stock-based compensation is too high or too low, it will have the effect of overstating or understating expenses. When stock-based grants are granted in exchange for the receipt of goods or services, we estimate the value of the stock-based compensation based upon the value of our common stock.

During the years 2010 and 2009, we issued approximately 0.8 million and 0.7 million stock options, respectively, with varying vesting provisions to certain of our employees and directors. Based on the Black-Scholes valuation method (volatility — 108.0% -109.0%, risk free rate — 2.17% - 2.39%, dividends — zero, weighted average life — 5 years; forfeiture — 10%), for the grants issued in 2010, we estimated $1.3 million of share-based compensation will be recognized as compensation expense over the vesting period, which will be amortized over the weighted average remaining requisite service period of 3.25 years. During years 2010 and 2009, we recognized total share-based compensation of approximately $0.9 million and $1.4 million, related to the options granted during 2010, 2009, 2008, 2007, 2006 and the unvested outstanding Maxim options as of January 4, 2006 that were converted into EpiCept options based on the vesting of those options during 2006. Future grants of options will result in additional charges for stock-based compensation that will be recognized over the vesting periods of the respective options.

Derivatives

As a result of certain financings, derivative instruments were created that we have measured at fair value and mark to market at each reporting period. Fair value of the derivative instruments will be affected by estimates of various factors that may affect the respective instrument, including our cost of capital, the risk free rate of return, volatility in the fair value of our stock price, future foreign exchange rates of the U.S. dollar to the euro and future profitability of our German subsidiary. At each reporting date, we review applicable assumptions and estimates relating to fair value and record any changes in the statement of operations.

Foreign Exchange Gains and Losses

We have a 100%-owned subsidiary in Germany, EpiCept GmbH, that performs certain commercialization activities on our behalf. EpiCept GmbH has generally been unprofitable since its inception. Its functional currency is the euro. The process by which EpiCept GmbH’s financial results are translated into U.S. dollars is as follows: income statement accounts are translated at average exchange rates for the period and balance sheet asset and liability accounts are translated at end of period exchange rates. Translation of the balance sheet in this manner affects the stockholders’ deficit account, referred to as the cumulative translation adjustment account. This account exists only in EpiCept GmbH’s U.S. dollar balance sheet and is necessary to keep the foreign balance sheet stated in U.S. dollars in balance.

Certain of our debt instruments, originally expressed in German deutsche marks, are now denominated in euros. Changes in the value of the euro relative to the value of the U.S. dollar will affect the U.S. dollar value of our indebtedness at each reporting date as substantially all of our assets are held in U.S. dollars. These changes are recognized by us as a foreign currency transaction gain or loss, as applicable, and are reported in other expense or income in our consolidated statements of operations.

Research and Development Expenses

We expect that a large percentage of our future research and development expenses will be incurred in support of current and future preclinical and clinical development programs. These expenditures are subject to numerous uncertainties in timing and cost to completion. We test our product candidates in numerous preclinical studies for toxicology, safety and efficacy. We then conduct early stage clinical trials for each drug candidate. As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain product candidates or programs in order to focus resources on more promising product candidates or programs. Completion of clinical trials may take several years but the length of time generally varies according to the type, complexity, novelty and intended use of a drug candidate. The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including:

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the number of sites included in the trials;

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the length of time required to enroll suitable patients;

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the number of patients that participate in the trials;

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the number of doses that patients receive;

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the duration of follow-up with the patient;

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the product candidate’s phase of development; and

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the efficacy and safety profile of the product.

Expenses related to clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and clinical research organizations that conduct clinical trials on the our behalf. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, estimates of expenses are modified accordingly on a prospective basis.

Ceplene^® has been granted full marketing authorization by the European Commission for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia in first remission. None of our other drug candidates has received FDA or foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign regulatory agencies must conclude that our clinical data and that of our collaborators establish the safety and efficacy of our drug candidates. Furthermore, our strategy includes entering into collaborations with third parties to participate in the development and commercialization of our products. In the event that third parties have control over the preclinical development or clinical trial process for a product candidate, the estimated completion date would largely be under control of that third party rather than under our control. We cannot forecast with any degree of certainty which of our drug candidates will be subject to future collaborations or how such arrangements would affect our development plan or capital requirements.

Recent Accounting Pronouncements

In March 2010, the FASB issued ASU 2010-17 “Revenue Recognition — Milestone Method” (ASC Topic 605). The guidance in this consensus allows the use of the milestone method as an acceptable revenue recognition methodology when an arrangement includes substantive milestones. The guidance provides a definition of substantive milestone and should be applied regardless of whether the arrangement includes single or multiple deliverables or units of accounting. The scope of this consensus is limited to the transactions involving milestones relating to research and development deliverables. The guidance includes enhanced disclosure requirements about each arrangement, individual milestones and related contingent consideration, information about substantive milestones and factors considered in the determination. The consensus is effective prospectively to milestones achieved in fiscal years, and interim periods within those years, after June 15, 2010. Early application and retrospective application are permitted. We have chosen early adoption of this pronouncement effective January 1, 2010 on a prospective basis. The early adoption did not have a material effect on our financial statements.

On October 7, 2009, the FASB issued ASU 2009-13, “Multiple Revenue Arrangements — a Consensus of the FASB Emerging Issues Task Force” which supersedes certain guidance in ASC 605-25, “Revenue Recognition-Multiple Element Arrangements,” and requires an entity to allocate arrangement consideration to all of its deliverables at the inception of an arrangement based on their relative selling prices (i.e., the relative-selling-price method). The use of the residual method of allocation will no longer be permitted in circumstances in which an entity recognized revenue for an arrangement with multiple deliverables subject to ASC 605-25. ASU 2009-13 also requires additional disclosures. We adopted the provisions of ASU 2009-13 beginning on January 1, 2011. Based on our current revenue arrangements, the adoption of ASU 2009-13 is not expected to have a material impact on our financial statements.

Results of Operations

Years Ended December 31, 2010 and 2009

Revenues. During the years 2010 and 2009, we recognized revenue of approximately $0.8 million and $0.4 million, respectively, from prior upfront licensing fees and milestone payments received from our strategic alliances and royalties with respect to certain technology; and $0.2 million and $0, respectively, in product revenues from the sales of Ceplene^® to Meda. We recognized revenue from our agreement with Endo using the proportional performance method with respect to LidoPAIN BP, from our agreement with Meda using the milestone method and on a straight line method over the life of the last to expire patent with Myrexis, DURECT and GNI. During the years 2010 and 2009, we recognized revenue of $33,000 and $40,000 from royalties with respect to acquired Maxim technology.

The current portion of deferred revenue as of December 31, 2010 of $0.9 million represents our estimate of revenue to be recognized over the next twelve months primarily related to the upfront payments from Meda, Myrexis, Endo, DURECT and GNI, Ltd.

Cost of goods sold. Cost of goods sold was $1.0 million and $0 for the years 2010 and 2009, respectively. Cost of goods sold related solely to the costs of sales of Ceplene^®, including manufacturing costs and royalty expense related to sales of Ceplene^®. During 2010, we expensed $0.9 million of Ceplene^® inventory as we believe such inventory will not be sold prior to reaching its product expiration date.

Selling, general and administrative expense. General and administrative expense decreased by 4%, or $0.3 million, to $7.2 million for 2010 from $7.5 million in 2009. The overall decrease in administrative expense can be attributed to continued cost reduction efforts in 2010. For 2010, stock-based compensation charges amounted to $0.7 million, or a decrease of $0.2 million from 2009. In addition, our accounting, investor relations and public reporting expense decreased $0.3 million for 2010 as compared to the same period in 2009, partially offset by higher legal and other administrative expenses of $0.3 million related to exploring alternative financing opportunities. Selling expenses have been significantly reduced, and we expect general and administrative expenses to remain at approximately current levels over the next few quarters.

Research and development expense. Research and development expense decreased by 30%, or $3.5 million, to $8.1 million for 2010 from $11.6 million for 2009. The decrease was primarily attributable to $2.0 million in lower salary and salary related expenses and facility costs related to closing our research facility in San Diego in 2009, lower clinical trial expenses for Ceplene^® of $0.9 million, lower license fees of $0.5 million and lower stock-based compensation charges of $0.2 million, partially offset by higher regulatory fees of $0.3 million. During 2010, our research and development efforts were focused on our open label trial of Ceplene^® that will meet our post-approval requirements with the EMA and on preparation of the NDA for Ceplene^® that was submitted in June 2010. During 2009, our clinical efforts were focused on the completion of our clinical trials of NP-1 and our Phase I clinical trial of crolibulin^TM and the commencement of our open label trial of Ceplene^® that will meet our post-approval requirements with the EMA.

For the years ended December 31, 2010 and 2009, we incurred the following research and development expense:

		2010				2009
		(in thousands)
Direct Expenses:
Ceplene®		$	4,081			$	3,896
NP-1			523				971
CrolibulinTM			131				705
Other projects			16				46
			4,751				5,618
Indirect Expenses:
Staffing			1,492				2,591
Other indirect			1,884				3,394
			3,376				5,985
Total Research & Development		$	8,127			$	11,603

Direct expenses consist primarily of fees paid to vendors and consultants for services related to preclinical product development, clinical trials, and manufacturing of the respective products. Generally, we have flexibility with respect to the timing and magnitude of a significant portion of our direct expenses. Indirect expenses are those expenses we incur that are not allocated by project, which consist primarily of the salaries and benefits of our research and development staff and related premises.

Other income (expense), net. Our other income (expense), net consisted of the following for the years ended December 31, 2010 and 2009:

		2010				2009
		(in thousands)
Other income (expense), net consist of:
Interest expense		$	(361	)		$	(20,021	)
Change in value of warrants and derivatives			—				(305	)
Interest income			7				32
Other Income			733				—
Foreign exchange gain (loss)			(538	)			221
Other expense, net		$	(159	)		$	(20,073	)

During 2010, we recorded other expense, net of $0.2 million as compared to other expense, net of $20.1 million during 2009. The $19.9 million decrease in other expense, net was primarily related to $10.5 million in amortization of debt issuance costs and discount and $9.3 million in interest expense, which was paid from restricted cash, as a result of the conversion of $24.5 million of our 7.5556% convertible subordinated notes due 2014 into approximately 9.1 million shares of our common stock in 2009. Amortization of debt issuance costs was accelerated in December 2010 as a result of the termination of the Equity Distribution Agreement with Maxim Group LLC, which established an at-the-market program through which we had the right to sell, from time to time and at our sole discretion, shares of our common stock having an aggregate offering price of up to $15 million. Other income (expense) was negatively impacted by a $0.8 million change in foreign exchange gains though it was substantially offset by $0.7 million of other income from the Qualifying Therapeutic Discovery Project Program, or QTDP.

In October 2010, we were notified by the Internal Revenue Service that our application for the QTDP was certified and a grant in the amount of $0.7 million was approved. This grant was provided under a new section of the Internal Revenue Code that was enacted as part of the Patient Protection and Affordable Care Act of 2010. The program, which provides for grants and tax credits, is intended to benefit discovery projects that show a reasonable potential to result in new therapies to treat areas of unmet medical need, or detect or treat chronic or acute diseases and conditions; reduce long-term growth of health care costs in the United States; or significantly advance the goal of curing cancer within 30 years. We received the grant in November 2010.

Income Taxes. Income tax expense for each of the years ended December 31, 2010 and 2009 was $4,000. As of December 31, 2010 and 2009, we had federal net operating loss carryforwards, or NOLs, of $120.9 and $90.8 million, state NOLs of $115.6 and $95.5 million, and foreign NOLs of $15.6 and $15.0 million respectively, available to reduce future taxable income. Our federal and state NOLs will begin to expire after 2012 through 2030. In accordance with ASC 740, “Income Taxes,” we have provided a valuation allowance for the full amount of our net deferred tax assets because it is not more likely than not that we will realize future benefits associated with these deferred tax assets at December 31, 2010 and 2009.

Years Ended December 31, 2009 and 2008

Revenues. During the years 2009 and 2008, we recognized revenue of approximately $0.4 million and $0.3 million, respectively, from prior upfront licensing fees and milestone payments received from Myrexis, Endo, DURECT and GNI, Ltd. and royalties with respect to certain technology; and sales of Ceplene^® via the named-patient program. We recognized revenue from our agreement with Endo using the proportional performance method with respect to LidoPAIN BP and on a straight line method over the life of the last to expire patent with Myrexis and DURECT. During the years 2009 and 2008, we recognized revenue of $40,000 and $43,000 from royalties with respect to acquired Maxim technology.

The current portion of deferred revenue as of December 31, 2009 of $0.4 million represents our estimate of revenue to be recognized over the next twelve months primarily related to the upfront payments from Myrexis, Endo, DURECT and GNI, Ltd.

Selling, general and administrative expense. Selling, general and administrative expense decreased by 21%, or $2.1 million, to $7.5 million for 2009 from $9.6 million in 2008. The overall decrease in administrative expense can be attributed to a cost reduction effort implemented in 2008 and continued into 2009. For 2009, stock-based compensation charges amounted to $0.9 million, or a decrease of $0.9 million from 2008. In addition, our legal, accounting and public reporting expense decreased $0.5 million and our facility, insurance and other administrative expenses decreased $0.7 million for 2009 as compared to the same period in 2008.

Research and development expense. Research and development expense decreased by 8%, or $1.0 million, to $11.6 million for 2009 from $12.6 million for 2008. The decrease was primarily attributable to lower clinical trial and consulting expenses of $0.4 million, lower salary and salary related expenses of $1.1 million and lower patent expenses of $0.2 million in 2009 as compared to the same period in 2008, partially offset by a $0.8 million facility expense and $0.2 million in severance expense related to closing our research facility in San Diego.

During 2009, our clinical efforts were focused on the completion of our clinical trials of NP-1 and our Phase I clinical trial of crinobulin and the commencement of our open label trial of Ceplene^® that will meet our post-approval requirements with the EMA. During 2008, our clinical efforts were focused on the clinical trials of NP-1 and the ongoing Phase I clinical trial of crinobulin, preparation for the Oral Explanation meeting with the CHMP, the scientific committee of the EMA, regarding the remaining outstanding issues on the MAA for Ceplene^® and preparation for the reexamination of the negative determination issued by the CHMP regarding our marketing application for Ceplene^®.

For the years ended December 31, 2009 and 2008, we incurred the following research and development expense:

		2009				2008
		(in thousands)
Direct Expenses:
Ceplene®		$	3,896			$	2,004
NP-1			971				2,584
Crinobulin			705				908
Other projects			46				357
			5,618				5,853
Indirect Expenses:
Staffing			2,591				3,855
Other indirect			3,394				2,915
			5,985				6,770
Total Research & Development		$	11,603			$	12,623

Direct expenses consist primarily of fees paid to vendors and consultants for services related to preclinical product development, clinical trials, and manufacturing of the respective products. Generally, we have flexibility with respect to the timing and magnitude of a significant portion of our direct expenses. Indirect expenses are those expenses we incur that are not allocated by project, which consist primarily of the salaries and benefits of our research and development staff and related premises.

Other income (expense), net. Our other income (expense), net consisted of the following for the years ended December 31, 2009 and 2008:

		2009				2008
		(in thousands)
Other income (expense), net consist of:
Interest expense		$	(20,021	)		$	(1,266	)
Change in value of warrants and derivatives			(305	)			113
Interest income			32				33
Loss on extinguishment of debt			—				(1,975	)
Foreign exchange gain (loss)			221				(327	)
Other expense, net		$	(20,073	)		$	(3,422	)

During 2009, we recorded other expense, net of $20.1 million as compared to other expense, net of $3.4 million during 2008. The $16.7 million increase in other expense, net was primarily related to $10.5 million in amortization of debt issuance costs and discount and $9.3 million in interest expense, which was paid from restricted cash, as a result of the conversion of $24.5 million of our 7.5556% convertible subordinated notes due 2014 into approximately 9.1 million shares of our common stock in 2009. Other income (expense) was positively impacted by a $0.5 million change in foreign exchange gains though it was substantially offset by a $0.4 million decrease in the fair value of certain warrants and derivatives. The Company experienced a loss on extinguishment of debt of $2.0 million in 2008.

Income Taxes. Income tax expense for the years ended December 31, 2009 and 2008 was $4,000 and $3,000, respectively. As of December 31, 2009 and 2008, we had federal net operating loss carryforwards, or NOLs, of $90.8 and $87.4 million, state NOLs of $95.5 and $95.6 million, and foreign NOLs of $15.0 and $14.7 million respectively, available to reduce future taxable income. Our federal and state NOLs will begin to expire after 2012 through 2029. In accordance with ASC 740, “Income Taxes,” we have provided a valuation allowance for the full amount of our net deferred tax assets because it is not more likely than not that we will realize future benefits associated with these deferred tax assets at December 31, 2009 and 2008.

Liquidity and Capital Resources

We have devoted substantially all of our cash resources to research and development programs and general and administrative expenses. To date, we have not generated any significant revenues from the sale of products and may not generate any such revenues for a number of years, if at all. As a result, we have incurred an accumulated deficit of $250.6 million as of December 31, 2010, and we anticipate that we will continue to incur operating losses in the future. Our recurring losses from operations and our stockholders’ deficit raise substantial doubt about our ability to continue as a going concern. Should we be unable to generate sufficient revenue from the sale of Ceplene^® or raise adequate financing in the future, operations will need to be scaled back or discontinued. Since our inception, we have financed our operations primarily through the proceeds from the sales of common and preferred securities, debt, revenue from collaborative relationships, investment income earned on cash balances and short-term investments and the sales of a portion of our New Jersey net operating loss carryforwards.

The following table describes our liquidity and financial position on December 31, 2010 and 2009.

		December 31,				December 31,
		2010				2009
		(in thousands)
Working capital (deficit)		$	(1,887	)		$	1,407
Cash and cash equivalents			2,435				5,142
Notes and loans payable, current portion			524				985
Notes and loans payable, long term portion			448				967

Working Capital (Deficit)

As of December 31, 2010, we had a working capital deficit of $1.9 million, consisting of current assets of $2.9 million and current liabilities of $4.8 million. This represents an unfavorable change in working capital of approximately $3.3 million from our working capital of $1.4 million consisting of current assets of $6.9 million and current liabilities of $5.5 million as of December 31, 2009. We funded our working capital deficit and the cash portion of our 2009 operating loss with $18.3 million in gross proceeds from our November 2010, June 2010 and June 2009 financings, $0.1 million in proceeds from the sale of our stock utilizing our at-the-market program and the receipt of $5.0 million from Meda in connection with the Ceplene^® European marketing and distribution agreement.

Cash and Cash Equivalents

At December 31, 2010, our cash and cash equivalents totaled $2.4 million. At December 31, 2009, cash and cash equivalents totaled $5.1 million. Our cash and cash equivalents consist primarily of an interest bearing money market account. In January 2010, we received $3.0 million from Meda in connection with the signing of the Ceplene^® European marketing and distribution agreement and in May 2010 we received $2.0 million from Meda in connection with the launch of Ceplene^® in Europe. In June 2010, we sold approximately 6.1 million shares of common stock and warrants to purchase 11.0 million shares of common stock for gross proceeds of $6.7 million, $6.2 million net of $0.5 million in transactions costs. In November 2010, we sold approximately 3.3 million shares of common stock and warrants to purchase 1.5 million shares of common stock for gross proceeds of $2.0 million, $1.9 million net of $0.1 million in transactions costs. During 2010, we sold approximately 31,000 shares of common stock through our at-the-market program for gross proceeds of $0.1 million and we received proceeds of $0.8 million from the exercise of approximately 1.4 million warrants.

In June 2009, we sold approximately 4.0 million shares of common stock and warrants to purchase 1.4 million shares of common stock for gross proceeds of $9.6 million, $8.9 million net of $0.7 million in transaction costs. In February 2009, we received net proceeds of approximately $14.0 million, after $1.6 million in transaction costs and establishing a restricted cash account of $9.4 million for make-whole interest, from the issuance of $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes due February 2014 and five and one-half year warrants to purchase approximately 4.2 million shares of the Company’s common stock at an exercise price of $3.105 per share.

Current and Future Liquidity Position

During 2010, we raised gross proceeds of $8.7 million, $8.1 million net of $0.6 million in transaction costs. In addition, we received $0.8 million upon exercise of certain warrants and a $0.7 million grant from the Internal Revenue Service under the Qualifying Therapeutic Discovery Project Program. As of December 31, 2010 we had approximately $2.4 million in cash and cash equivalents. In March 2011, we sold approximately 7.1 million shares of our common stock and warrants to purchase 5.3 million shares of our common stock for gross proceeds of $4.6 million, $4.3 million net of $0.3 million in transaction costs. In February 2011, we sold approximately 8.9 million shares of our common stock and warrants to purchase 3.6 million shares of our common stock for gross proceeds of $7.1 million, $6.6 million net of $0.5 million in transaction costs. Our anticipated average monthly cash operating expenses in 2011 is approximately $1.1 million per month. In addition, we are required to make a final interest and principal payment to our lender tbg on June 30, 2011 in the amount of approximately $0.5 million. We believe that our cash is sufficient to fund operations into 2012. We may receive cash from certain of our licensing partners during 2011 for achievement of clinical milestones, and we anticipate raising additional funds through the issuance of debt and/or equity to meet our cash needs. To conserve cash, we may delay or cancel some of our planned development activities that are not related to Ceplene during 2011.

In November 2010 we provided an update with respect to our financing plans. The key element of the plan is a non-equity financing transaction that, if fully completed, will support our operations for an additional year. We anticipate that the transaction, which is subject to completion of due diligence and execution of mutually-satisfactory documentation, will close in 2011, but should the transaction not close or the proceeds be less than anticipated we may determine to seek additional or alternative sources or types of financing, including equity financing.

We plan to out license our NP-1 compound to a third party who will agree to complete clinical development and commercialize the product upon receipt of necessary regulatory approvals. Discussions with prospective partners are continuing, however at this time we are unable to determine whether or when such an agreement might be concluded or the amount of any fees that may be paid to us in 2011 in connection with the agreement.

If additional funds are raised by issuing equity, substantial dilution to existing shareholders may result. If we fail to obtain capital when required, we may be forced to delay, scale back, or eliminate some or all of our commercialization efforts for Ceplene and our research and development programs or to cease operations entirely.

Our future capital uses and requirements depend on numerous forward-looking factors. These factors include, but are not limited to, the following:

•

revenues generated from the sale of Ceplene® in Europe, including payments from our marketing partner;

•

manufacturing costs of Ceplene®

•

the timing, receipt and amount of front-end fees and milestone payments that may become payable through an NP-1 license;

•

progress in our research and development programs, as well as the magnitude of these programs;

•

the timing, receipt and amount of milestone and other payments, if any, from present and future collaborators, if any;

•

the ability to establish and maintain additional collaborative arrangements;

•

the resources, time and costs required to successfully initiate and complete our preclinical and clinical trials, obtain regulatory approvals, protect our intellectual property;

•

the cost of preparing, filing, prosecuting, maintaining and enforcing patent claims; and

•

the timing, receipt and amount of sales and royalties, if any, from our potential products.

Our ability to raise additional capital will depend on financial, economic and market conditions and other factors, many of which are beyond our control. We cannot be certain that such additional funding will be available upon acceptable terms, or at all. To the extent that we raise additional capital by issuing equity securities, our then-existing stockholders may experience further dilution. Our sales of equity have generally included the issuance of warrants, and if these warrants are exercised in the future, stockholders may experience significant additional dilution. We may not be able to raise additional capital through the sale of our securities which would severely limit our ability to fund our operations. Debt financing, if available, may subject us to restrictive covenants that could limit our flexibility in conducting future business activities. Given our available cash resources, existing indebtedness and results of operations, obtaining debt financing may not be possible. To the extent that we raise additional capital through collaboration and licensing arrangements, it may be necessary for us to relinquish valuable rights to our product candidates that we might otherwise seek to develop or commercialize independently.

Operating Activities

Net cash used in operating activities was $10.4 million in 2010, as compared to $29.5 million in 2009 and $15.6 million in 2008. In 2010, cash was primarily used to fund our net loss for the year for research and development, selling, general, administrative and other expenses. The 2010 net loss was partially offset by non-cash charges of $0.9 million in stock-based compensation, $0.2 million in amortization of deferred financing costs and discount on loans and $0.2 million of depreciation and amortization expense. The 2010 net loss was also partially offset by a $5.0 million increase in deferred revenue in connection with the Ceplene^® European marketing and distribution agreement with Meda, a $0.9 million expense for excess inventory of Ceplene^® that we believe will not be sold prior to reaching its product expiration date and $0.5 million in foreign exchange loss. Inventory increased by $0.5 million as we prepared for the launch of Ceplene in Europe and deferred revenue decreased by $0.8 million to account for the portion of the Meda, Myrexis, Endo and DURECT deferred revenue recognized as revenue. Accounts payable and accrued expenses also decreased by $0.9 million as a result of payments to our vendors.

In 2009, cash was primarily used to fund our net loss for the year for research and development, general, administrative and interest expense. The net loss was partially offset by non-cash charges of $10.5 million in amortization of deferred financing costs and discount on loans, $1.4 million of stock-based compensation and $0.4 million of depreciation and amortization expense. Inventory increased by $1.3 million as we prepared for the launch of Ceplene in Europe and deferred revenue decreased by $0.4 million to account for the portion of the Myrexis, Endo and DURECT deferred revenue recognized as revenue. Accounts payable and accrued expenses also decreased by $1.8 million as a result of payments to our vendors.

Investing Activities

Net cash provided by investing activities was $0.1 million in 2010 compared with net cash used in investing activities was $0.1 million in 2009 and net cash provided by investing activities of $0.3 million in 2008. In 2010, cash was provided by the release of $40,000 from restricted cash to pay for interest on the 7.5556% notes and $27,000 from the sale of equipment in our San Diego research facility. In 2009, cash was used to establish restricted cash for a $9.4 million make-whole interest payment resulting from the issuance of $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes, the release of $9.3 million from restricted cash to pay for interest on the 7.5556% notes as the result of the conversion of $24.5 million in aggregate principal amount of the 7.5556% notes, $0.1 million in proceeds from the sale of equipment in our San Diego research facility and $27,000 for the purchase of equipment. We do not anticipate significant capital expenditures in the near future.

Financing Activities

Net cash provided by financing activities was $7.6 million in 2010 compared to $33.9 million in 2009 and $11.1 million in 2008. In June 2010, we raised $6.7 million in gross proceeds, $6.2 million net of $0.5 million in transaction costs, in connection with the issuance of common stock and warrants. In November 2010, we raised $2.0 million gross proceeds, $1.9 million net of $0.1 million in transaction costs, in connection with the issuance of common stock and warrants. During 2010, we sold approximately 31,000 shares of common stock through our at-the-market program for gross proceeds of $0.1 million. We also received proceeds of $0.8 million related to the exercise warrants in 2010 and paid $0.9 million towards the remaining balance of our loan with tbg.

In 2009, we issued $25.0 million principal aggregate amount of 7.5556% convertible senior subordinated notes, netting us $14.0 million after $1.6 million in transaction costs and establishing a restricted cash account of $9.4 million for make-whole interest. In June 2009, we raised $9.6 million gross proceeds, $8.9 million net of $0.7 million in transaction costs, in connection with the issuance of common stock and warrants. We also received proceeds of $3.9 million related to the exercise of approximately 3.4 million warrants in 2009. We repaid the outstanding loan balance with Hercules of approximately $8,000 and deferred financing costs of $0.2 million, resulting in our having no further obligations under this loan agreement. We also repaid $1.0 million of the subordinated convertible notes due April 10, 2009 and paid $0.9 million towards the remaining balance of our loan with tbg.

Contractual Obligations

As of December 31, 2010, the annual amounts of future minimum payments under debt obligations, interest, lease obligations and other long term liabilities consisting of research, development, consulting and license agreements (including maintenance fees) are as follows (in thousands of U.S. dollars, using exchange rates where applicable in effect as of December 31, 2010):

		Less than												More than
		1 Year				1 - 3 Years				3 - 5 Years				5 Years				Total
Notes and loans payable		$	524			$	62			$	500			$	—			$	1,086
Interest expense			67				78				3				—				148
Operating leases			1,089				1,469				—				—				2,558
Other obligations			2,386				2,318				159				—				4,863
Total		$	4,066			$	3,927			$	662			$	—			$	8,655

€1.5 Million Due 2011. In August 1997, our subsidiary, EpiCept GmbH entered into a ten-year non-amortizing loan in the amount of €1.5 million with Technologie-Beteiligungs Gesellschaft mbH der Deutschen Ausgleichsbank, or tbg. The loan initially bore interest at 6% per annum. Tbg was also entitled to receive additional compensation equal to 9% of the annual surplus (income before taxes, as defined in the agreement) of EpiCept GmbH, reduced by any other compensation received from EpiCept GmbH by virtue of other loans to or investments in EpiCept GmbH provided that tbg is an equity investor in EpiCept GmbH during that time period. We considered the additional compensation element based on the surplus of EpiCept GmbH to be a derivative. We assigned no value to the derivative at each reporting period as no surplus of EpiCept GmbH was anticipated over the term of the agreement. In addition, any additional compensation as a result of surplus would be reduced by the additional interest noted below.

At the demand of tbg, additional amounts could have been due at the end of the loan term up to 30% of the loan amount, plus 6% of the principal balance of the loan for each year after the expiration of the fifth complete year of the loan period, such payments to be offset by the cumulative amount of all payments made to tbg from the annual surplus of EpiCept GmbH. We were accruing these additional amounts as additional interest up to the maximum amount due over the term of the loan.

On December 20, 2007, EpiCept GmbH entered into a repayment agreement with tbg, whereby EpiCept GmbH paid tbg approximately €0.2 million ($0.2 million) in January 2008, representing all interest payable to tbg as of December 31, 2007. The loan balance of €1.5 million ($2.0 million), plus accrued interest at a rate of 7.38% per annum beginning January 1, 2008 was required to be repaid to tbg no later than June 30, 2008. Tbg waived any additional interest payments of approximately €0.5 million ($0.7 million). EpiCept GmbH considered this a substantial modification to the original debt agreement and has recorded the new debt at its fair value in accordance with ASC 470-50, “Modifications and Extinguishments” (“ASC 470-50”). As a result of the modification to the original debt agreement, EpiCept GmbH recorded a gain on the extinguishment of debt of $0.5 million in December 2007. Accrued interest attributable to the additional interest payments totaled $0 at December 31, 2009 and 2008.

On May 14, 2008, EpiCept GmbH entered into a prolongation of the repayment agreement with tbg, whereby the loan balance of €1.5 million ($2.0 million) was required to be repaid to tbg no later than December 31, 2008. Interest continued to accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated December 20, 2007 continued to apply without change.

On November 26, 2008, EpiCept GmbH entered into a second amendment to the repayment agreement with tbg, whereby the loan balance of €1.5 million ($2.0 million) was required to be repaid to tbg no later than June 30, 2009. Interest will continue to accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated December 20, 2007 will continue to apply without change.

On June 25, 2009, EpiCept GmbH entered into a third amendment to the repayment agreement with tbg, whereby €0.3 million of the loan balance of €1.5 million ($2.1 million) plus accrued interest of €56,000 ($0.1 million) was repaid to tbg on June 30, 2009. The remaining loan balance of €1.2 million ($1.7 million) plus accrued interest will be paid in four semi-annual installments of €0.3 million ($0.4 million) beginning December 31, 2009. Interest will continue to accrue at a rate of 7.38% per annum and all the provisions of the repayment agreement dated December 20, 2007 will continue to apply without change.

$25.0 million 7.5556% Convertible Notes Due 2014. On February 4, 2009, we issued $25.0 million principal aggregate amount of 7.5556% convertible subordinated notes due February 2014 and five and-a-half year warrants to purchase approximately 4.2 million shares of common stock at an exercise price of $3.105 per share. Each $1,000 in principal aggregate amount of the notes is initially convertible into approximately 371 shares of Common Stock, at the option of the holders or upon specified events, including a change of control, and if the Company’s common stock trades at or greater than $5.10 a share for 20 out of 30 days, beginning February 9, 2010. Upon any conversion or redemption of the notes, the holders will receive a make-whole payment in an amount equal to the interest payable through the scheduled maturity of the converted or redeemed notes, less any interest paid before such conversion or redemption. Interest is due and payable on the notes semi-annually in arrears on June 30 and December 31, beginning on June 30, 2009.

The Company allocated the $25.0 million in proceeds between the convertible subordinated notes and the warrants based on their relative fair values. The Company calculated the fair value of the warrants at the date of the transaction at approximately $8.8 million with a corresponding amount recorded as a debt discount. The debt discount is being accreted over the life of the outstanding convertible subordinated notes using the effective interest method. At the date of the transaction, the fair value of the warrants of $8.8 million was determined utilizing the Black-Scholes option pricing model under the following assumptions: dividend yield of 0%, risk free interest rate of 1.99%, volatility of 118% and an expected life of five years. During 2009, the Company recognized approximately $8.6 million of non-cash interest expense related to the accretion of the debt discount as a result of the conversion of $24.5 million of the convertible subordinated notes into approximately 9.1 million shares of the Company’s common stock.

As of December 31, 2010, after giving effect to the conversions into common stock, the remaining aggregate principal amount of the Notes outstanding is $0.5 million.

$0.8 million Due 2012. In July 2006, Maxim, our wholly-owned subsidiary, issued a six-year non-interest bearing promissory note in the amount of $0.8 million to Pharmaceutical Research Associates, Inc., or PRA, as compensation for PRA assuming the liability on a lease in San Diego, CA. The note is payable in seventy-two equal installments of approximately $11,000 per month. We terminated our lease of certain property in San Diego, CA as part of our exit plan upon the completion of the merger with Maxim on January 4, 2006. Our loan balance at December 31, 2010 is $0.2 million.

Other Commitments. Our long-term commitments under operating leases shown above consist of payments relating to our facility lease in Tarrytown, New York, which expires in February 2012, and Munich, Germany, which was due to expire in July 2011. In January 2011, our operating lease in Munich, Germany was extended to July 2014. Long-term commitments under operating leases for facilities leased by Maxim and retained by us relate primarily to the research and development site at 6650 Nancy Ridge Drive in San Diego, which is leased through October 2013. In June 2008, we defaulted on our lease agreement for the premises located in San Diego, California by failing to make the monthly rent payment. As a result, the landlord exercised their right to draw down the full letter of credit, amounting to approximately $0.3 million, and applied approximately $0.2 million to unpaid rent. The remaining balance of $0.1 million is classified as prepaid rent. At December 31, 2010, we are current with our lease payments on this facility. We discontinued our drug discovery activities at this location and are currently looking to sublease the premises located in San Diego, California.

We have a number of research, consulting and license agreements that require us to make payments to the other party to the agreement upon us attaining certain milestones as defined in the agreements. As of December 31, 2010, we may be required to make future milestone payments, totaling approximately $4.9 million, under these agreements, depending upon the success and timing of future clinical trials and the attainment of other milestones as defined in the respective agreement. Our current estimate as to the timing of other research, development and license payments, assuming all related research and development work is successful, is listed in the table above in “Other obligations.”

We are also obligated to make future royalty payments to three of our collaborators under existing license agreements, based on net sales of Ceplene^®, NP-1 and crolibulin^TM, to the extent revenues on such products are realized. We cannot reasonably determine the amount and timing of such royalty payments and they are not included in the table above.

ITEM 7A.		QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISKS

The financial currency of our German subsidiary is the euro. As a result, we are exposed to various foreign currency risks. First, our consolidated financial statements are in U.S. dollars, but a portion of our consolidated assets and liabilities is denominated in euros. Accordingly, changes in the exchange rate between the euro and the U.S. dollar will affect the translation of our German subsidiary’s financial results into U.S. dollars for purposes of reporting consolidated financial results. We also bear the risk that interest on our euro-denominated debt, when translated from euros to U.S. dollars, will exceed our current estimates and that principal payments we make on those loans may be greater than those amounts currently reflected on our consolidated balance sheet. If the U.S. dollar depreciation to the euro had been 10% more throughout 2010, we estimate that our interest expense and the fair value of our euro-denominated debt would have increased by $8,000 and $41,000, respectively. Historically, fluctuations in exchange rates resulting in transaction gains or losses have had a material effect on our consolidated financial results. We have not engaged in any hedging activities to minimize this exposure, although we may do so in the future.

Our exposure to interest rate risk is limited to interest income sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because the majority of our investments are in short-term debt securities and bank deposits. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. To minimize risk, we maintain our portfolio of cash and cash equivalents in a variety of interest- bearing instruments, primarily bank deposits and money market funds, which may also include U.S. government and agency securities, high-grade U.S. corporate bonds and commercial paper. Due to the nature of our short-term and restricted investments, we believe that we are not exposed to any material interest rate risk. We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. Therefore, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships. We do not have relationships or transactions with persons or entities that derive benefits from their non-independent relationship with us or our related parties.

ITEM 8.		FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

See our consolidated financial statements filed with this Annual Report on Form 10-K under Item 15 below.

ITEM 9.		CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A.		CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Our Chief Executive Officer and Chief Financial Officer, with the assistance of other members of our management, have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2010, our disclosure controls and procedures were effective.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2010. Management based this assessment on criteria for effective internal control over financial reporting described in “Internal Control-Integrated Framework” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Management’s assessment included an evaluation of the design of the Company’s internal control over financial reporting and testing of the operational effectiveness of its internal control over financial reporting. Management reviewed the results of its assessment with the Audit Committee.

There have not been any changes in our internal control over financial reporting (as defined in Rule 13a-15(f)) during the fiscal quarter ended December 31, 2010 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Based on this assessment, management determined that, as of December 31, 2010, the Company’s internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America.

ITEM 9B.		OTHER INFORMATION

None.

PART III

ITEM 10.		DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Management and Board of Directors

The information concerning our directors, executive officers and corporate governance required under this Item is incorporated herein by reference from our proxy statement, which will be filed with the Securities and Exchange Commission, relating to our 2011 Annual Meeting of Stockholders (referred to as our 2011 Proxy Statement).

ITEM 11.		EXECUTIVE COMPENSATION

The information required under this Item is incorporated herein by reference from our 2011 Proxy Statement.

ITEM 12.		SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required under this Item is incorporated herein by reference from our 2011 Proxy Statement.

ITEM 13.		CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

The information required under this Item is incorporated herein by reference from our 2011 Proxy Statement.

ITEM 14.		PRINCIPAL ACCOUNTANT FEES AND SERVICES

The information required under this Item is incorporated herein by reference from our 2011 Proxy Statement.

PART IV

ITEM 15.		EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

(a)

(1) and (2) Financial Statements and Financial Statement Schedules

The following consolidated financial statements of EpiCept Corporation and subsidiaries, the notes thereto and the related report thereon of independent registered public accounting firm are filed under Item 8 of this report.

Report of Independent Registered Public Accounting Firm

Consolidated Balance Sheets as of December 31, 2010 and 2009

Consolidated Statements of Operations for the Years Ended December 31, 2010, 2009 and 2008

Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2010, 2009 and 2008

Consolidated Statements of Cash Flows for the Years Ended December 31, 2010, 2009 and 2008

Notes to Consolidated Financial Statements

Schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission are omitted because they either are not required under the related instructions, are inapplicable, or the required information is shown in the consolidated financial statements or the notes thereto.

(a)		(3) See Exhibits Index.
(b)		Exhibits. See Item 15 (a) (3) above.
(c)		Financial Statement Schedules

None.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons in the capacities indicated and on the dates indicated:

Signature		Title		Date
/s/ John V. Talley   John V. Talley		Director, President and Chief Executive Officer (Principal Executive Officer)		March 31, 2011
/s/ Robert W. Cook   Robert W. Cook		Chief Financial Officer (Principal Financial and Accounting Officer)		March 31, 2011
/s/ Robert G. Savage   Robert G. Savage		Director		March 31, 2011
/s/ Guy C. Jackson   Guy C. Jackson		Director		March 31, 2011
/s/ Gerhard Waldheim   Gerhard Waldheim		Director		March 31, 2011
/s/ Wayne P. Yetter   Wayne P. Yetter		Director		March 31, 2011
/s/ A. Collier Smyth   A. Collier Smyth		Director		March 31, 2011

INDEX TO FINANCIAL STATEMENTS

EPICEPT CORPORATION AND SUBSIDIARIES CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm			F-2
Consolidated Balance Sheets as of December 31, 2010 and 2009			F-3
Consolidated Statements of Operations for the Years Ended December 31, 2010, 2009 and 2008			F-4
Consolidated Statements of Stockholders’ Deficit for the Years Ended December 31, 2010, 2009 and 2008			F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2010, 2009 and 2008			F-6
Notes to Consolidated Financial Statements			F-7

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of
Epicept Corporation

Tarrytown, NY

We have audited the accompanying consolidated balance sheets of EpiCept Corporation and subsidiaries (the “Company”) as of December 31, 2010 and 2009, and the related consolidated statements of operations, stockholders’ deficit, and cash flows for each of the three years in the period ended December 31, 2010. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of EpiCept Corporation and subsidiaries as of December 31, 2010, and 2009, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2010, in conformity with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company’s recurring losses from operations and stockholders’ deficit raise substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 2 to the consolidated financial statements. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ Deloitte & Touche LLP

Parsippany, New Jersey

March 31, 2011

EpiCept Corporation and Subsidiaries

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

		December 31,
		2010				2009
ASSETS
Current assets:
Cash and cash equivalents		$	2,435			$	5,142
Inventory			179				1,315
Prepaid expenses and other current assets			333				414
Total current assets			2,947				6,871
Restricted cash			189				227
Property and equipment, net			222				360
Long-term inventory			825				—
Deferred financing costs			506				28
Identifiable intangible asset, net			—				28
Total assets		$	4,689			$	7,514
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable		$	1,244			$	1,808
Accrued research contract costs			859				1,174
Other accrued liabilities			1,286				1,072
Notes and loans payable, current portion			524				985
Deferred revenue, current portion			921				425
Total current liabilities			4,834				5,464
Notes and loans payable			62				618
7.5556% Convertible Subordinated Notes Due 2014			386				349
Deferred revenue			12,905				9,197
Deferred rent and other noncurrent liabilities			637				965
Total long term liabilities			13,990				11,129
Total liabilities			18,824				16,593
Commitments and contingencies
Stockholders’ Deficit:
Common stock, $.0001 par value; authorized 225,000,000 shares; issued 54,991,535 shares and 44,051,782 shares at December 31, 2010 and 2009, respectively			5				4
Additional paid-in capital			210,540				203,445
Warrants			27,227				24,503
Accumulated deficit			(250,582	)			(235,045	)
Accumulated other comprehensive loss			(1,250	)			(1,911	)
Treasury stock, at cost (4,167 shares)			(75	)			(75	)
Total stockholders’ deficit			(14,135	)			(9,079	)
Total liabilities and stockholders’ deficit		$	4,689			$	7,514

The accompanying notes are an integral part of these consolidated financial statements.

EpiCept Corporation and Subsidiaries

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

		Year Ended December 31,
		2010				2009				2008
Net product sales		$	158			$	—			$	—
Licensing and other revenue			836				414				265
Revenue			994				414				265
Costs and expenses:
Costs of goods sold			997				—				—
Selling, general and administrative			7,244				7,548				9,599
Research and development			8,127				11,603				12,623
Total costs and expenses			16,368				19,151				22,222
Loss from operations			(15,374	)			(18,737	)			(21,957	)
Other income (expense), net:
Interest income			7				32				33
Foreign exchange gain (loss)			(538	)			221				(327	)
Interest expense (See note 3)			(361	)			(20,021	)			(1,266	)
Other income (See note 3)			733				—				—
Change in value of warrants and derivatives			—				(305	)			113
Loss on extinguishment of debt			—				—				(1,975	)
Other expense, net			(159	)			(20,073	)			(3,422	)
Loss before income tax expense			(15,533	)			(38,810	)			(25,379	)
Income tax expense			(4	)			(4	)			(3	)
Net loss		$	(15,537	)		$	(38,814	)		$	(25,382	)
Basic and diluted loss per common share		$	(0.32	)		$	(0.97	)		$	(1.23	)
Weighted average common shares outstanding			47,853,560				40,139,299				20,685,711

The accompanying notes are an integral part of these consolidated financial statements.

EpiCept Corporation and Subsidiaries

																						Accumulated
										Additional												Other
		Common Stock								Paid-In								Accumulated				Comprehensive				Treasury				Stockholders’
		Shares				Amount				Capital				Warrants				Deficit				(Loss) Income				Stock				Deficit
Balance at January 1, 2008			15,294,008				2				148,770				10,025				(170,849	)			(2,050	)			(75	)			(14,177	)
Net loss			—				—				—				—				(25,382	)			—				—				(25,382	)
Foreign currency translation adjustment			—				—				—				—				—				432				—				432
Comprehensive loss, net of tax			—				—				—				—				(25,382	)			432				—				(24,950	)
Exercise of warrants			2,097,860				—				4,159				(1,599	)			—				—				—				2,560
Issuance of common stock and warrants, net			8,718,304				1				8,386				4,930				—				—				—				13,317
Issuance of common stock under ESPP			166,667				—				102				—				—				—				—				102
Issuance of common stock as payment of loan			1,197,411				—				1,850				—				—				—				—				1,850
Issuance of restricted common stock, net			11,468				—				50				—				—				—				—				50
Issuance of warrants			—				—				—				1,288				—				—				—				1,288
Amortization of deferred stock compensation			—				—				2,230				—				—				—				—				2,230
Balance at December 31, 2008			27,485,718				3				165,547				14,644				(196,231	)			(1,618	)			(75	)			(17,730	)
Net loss			—				—				—				—				(38,814	)			—				—				(38,814	)
Foreign currency translation adjustment			—				—				—				—				—				(293	)			—				(293	)
Comprehensive loss, net of tax			—				—				—				—				(38,814	)			(293	)			—				(39,107	)
Reclass warrants from liability to equity			—				—				—				2,288				—				—				—				2,288
Issuance of common stock warrants in connection with 7.5556% convertible subordinated notes			—				—				—				8,777				—				—				—				8,777
Issuance of common stock and warrants, net			4,000,000				—				6,900				—				—				—				—				6,900
Issuance of restricted common stock and restricted stock units, net			22,670				—				55				—				—				—				—				55
Issuance of common stock under ESPP			49,065				—				75				—				—				—				—				75
Conversion of 7.5556% convertible subordinated notes into Common Stock			9,074,065				1				24,499				—				—				—				—				24,500
Exercise of warrants			3,361,375				—				4,976				(1,206	)			—				—				—				3,770
Exercise of stock options			58,889				—				53				—				—				—				—				53
Amortization of deferred stock compensation			—				—				1,340				—				—				—				—				1,340
Balance at December 31, 2009			44,051,782			$	4			$	203,445			$	24,503			$	(235,045	)		$	(1,911	)		$	(75	)		$	(9,079	)
Net loss			—				—				—				—				(15,537	)			—				—				(15,537	)
Foreign currency translation adjustment			—				—				—				—				—				661				—				661
Comprehensive loss, net of tax			—				—				—				—				(15,537	)			661				—				(14,876	)
Issuance of common stock and warrants, net of issuance costs			9,445,554				1				4,483				3,604				—				—				—				8,088
Issuance of common stock resulting from reverse split			3,828				—				—				—				—				—				—				—
Issuance of restricted common stock and restricted stock units, net			22,349				—				30				—				—				—				—				30
Issuance of common stock under ESPP			32,821				—				23				—				—				—				—				23
Exercise of warrants			1,435,201				—				1,653				(880	)			—				—				—				773
Amortization of deferred stock compensation			—				—				906				—				—				—				—				906
Balance at December 31, 2010			54,991,535			$	5			$	210,540			$	27,227			$	(250,582	)		$	(1,250	)		$	(75	)		$	(14,135	)