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8-K - 8-K - SPECTRUM PHARMACEUTICALS INC | a59395e8vk.htm |
Exhibit 99.1
COMPANY CONTACT
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x 216
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x 216
FDA
APPROVES FUSILEV® FOR USE IN PATIENTS WITH COLORECTAL CANCER
| Colorectal Cancer is the Third Most Common Cancer in the United States | ||
| There are Approximately 140,000 New Cases and 50,000 Deaths Annually | ||
| Ex-U.S. Sales of Levoleucovorin Are Approximately $180 Million Annually | ||
| FUSILEV® Sales Exceeded $34M in the First Quarter of 2011, Resulting in a Second Consecutive Profitable Quarter. |
IRVINE, California April 29, 2011 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a
biotechnology company with fully integrated commercial and drug development operations with a
primary focus in oncology, received approval from the U.S. Food and Drug Administration (FDA) on
April 29, 2011, for the use of FUSILEV® (levoleucovorin) in combination with
5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
This new, expanded indication supplements the original 2008 FDA approval of FUSILEV.
We are pleased that the FDA has approved FUSILEV for use in colorectal cancer, said Rajesh C.
Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
Although the NCCN Guidelines in the United States already recommend levoleucovorin in the
treatment of colorectal cancer patients, we could not promote FUSILEV for this indication until
now. We believe that the FDA approval of FUSILEV in the treatment of colorectal cancer could
represent a significant growth catalyst for Spectrum. In the United States, more than 90% of its
clinical use is for the treatment of patients with colorectal cancer. FUSILEV, under various trade
names, has been available in Europe and Japan primarily by Wyeth, Sanofi-Aventis, and Takeda
Pharmaceuticals. It is estimated that ex-U.S. sales of FUSILEV are in excess of $180 million a
year.
According to the American Cancer Society, colorectal cancer is the third most commonly diagnosed
cancer and the third leading cause of cancer death in both men and women in the US, with
approximately 141,210 new cases and 49,380 deaths expected in 2011.
About FUSILEV® (levoleucovorin)
FUSILEV, a novel folate analog, is now approved as a ready-to-use (FUSILEV Injection) solution in
175 mg and 250 mg vials, and as freeze-dried powder (FUSILEV for Injection) in 50 mg vials.
FUSILEV is indicated for use in combination with 5-fluorouracil in the palliative treatment of
patients with advanced metastatic colorectal cancer. FUSILEV is also indicated for rescue after
high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity
and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of
folic acid antagonists. FUSILEV, under various trade names, is marketed outside the United States
by Wyeth, Sanofi-Aventis, and Takeda.
Important FUSILEV® (levoleucovorin) Safety Considerations
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to
folic acid or folinic acid. Due to calcium content, no more than 16-mL (160-mg) of levoleucovorin
solution should be injected intravenously per minute. FUSILEV enhances the cyto-toxicity of
fluorouracil. Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for pneumocystis
carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a
placebo-controlled study. Allergic reactions were reported in patients receiving FUSILEV. Vomiting
(38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue
after high dose methotrexate therapy. The most common adverse reactions (>50%) in patients with
advanced colorectal cancer receiving
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
FUSILEV in combination with 5-fluorouracil were diarrhea,
nausea and stomatitis. FUSILEV may
counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the
frequency of seizures in susceptible patients.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug
development operations with a primary focus in oncology. The Companys strategy is comprised of
acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and
commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two
drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of
novel drug candidates. The Company has assembled an integrated in-house scientific team, including
clinical development, medical research, regulatory affairs, biostatistics and data management,
formulation development, and has established a commercial infrastructure for the marketing of its
drug products. The Company also leverages the expertise of its worldwide partners to assist in the
execution of its strategy. For more information, please visit the Companys website at
www.sppirx.com.
Forward-looking statement This press release may contain forward-looking statements
regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks
and uncertainties that could cause actual results to differ materially. These statements include
but are not limited to statements that relate to our business and its future, including certain
company milestones, Spectrums ability to identify, acquire, develop and commercialize a broad and
diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of
partners and employees, around the world to assist us in the execution of our strategy, and any
statements that relate to the intent, belief, plans or expectations of Spectrum or its management,
or that are not a statement of historical fact. Risks that could cause actual results to differ
include the possibility that our existing and new drug candidates, may not prove safe or effective,
the possibility that our existing and new drug candidates may not receive approval from the FDA,
and other regulatory agencies in a timely manner or at all, the possibility that our existing and
new drug candidates, if approved, may not be more effective, safer or more cost efficient than
competing drugs, the possibility that our efforts to acquire or in-license and develop additional
drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on
third parties for clinical trials, manufacturing, distribution and quality control and other risks
that are described in further detail in the Companys reports filed with the Securities and
Exchange Commission. We do not plan to update any such forward-looking statements and expressly
disclaim any duty to update the information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®, and FUSILEV® are
registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE and the Spectrum
Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
157
Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI