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8-K - FORM 8-K - ALKERMES INC | b84351e8vk.htm |
Exhibit
99.1
Alkermes Contacts: For Investors: Rebecca Peterson, (781) 609-6378 For Media: Jennifer Snyder, (781) 609-6166 |
ALKERMES
ELECTS WENDY L. DIXON, PH.D., TO BOARD OF DIRECTORS
Waltham,
Mass., Jan. 18, 2011 Alkermes, Inc. (NASDAQ: ALKS) today
announced the election of
Wendy L. Dixon, Ph.D., to the companys board of directors. Most recently serving as Chief
Marketing Officer and President of Global Marketing for Bristol-Myers Squibb, Dr. Dixon has more
than 30 years of experience in the biopharmaceutical industry.
We are very pleased to welcome Wendy to our board. Wendys extensive experience in the
biopharmaceutical industry, and particularly her expertise in global marketing and business
development, will enable her to bring a significant strategic perspective to Alkermes as we execute
our launch of VIVITROL® for opioid dependence and advance our product candidates in
development, said Richard Pops, Chief Executive Officer of Alkermes.
During her tenure at Bristol-Myers Squibb, Dr. Dixon was responsible for the global
commercialization and launch strategies for all new products as well as continuing growth
strategies for all in-line products. Among the products launched under Dr. Dixons leadership were
ABILIFY® (aripiprazole) and REYATAZ® (atazanavir sulfate), both of which were
ranked in the top ten of recent pharmaceutical product launches. Dr. Dixon also oversaw the Market
Research, Strategic Planning, Decision Analysis and Forecasting, and Access, Pricing and
Reimbursement functions and was responsible for commercial evaluation of all in-licensing, merger
and acquisition and strategic partnerships while at Bristol-Myers Squibb.
Prior to joining Bristol-Myers Squibb in 2001, Dr. Dixon served as Senior Vice President of
Marketing for Mercks U.S. Human Health division and was responsible for the launch of six products
in two years, including VIOXX (rofecoxib) and SINGULAIR® (montelukast sodium), and for
driving the growth of FOSAMAX® (alendronate sodium) and other in-line products.
Previously, Dr. Dixon held various positions in strategic planning and business development,
marketing, regulatory affairs and general management at West Pharmaceuticals, Osteotech, Centocor
and Smith Kline & French Pharmaceuticals and began her career as a biochemist at Smith Kline &
French.
Alkermes has established itself in the industry as an innovative leader in the development of
breakthrough products in major disease areas, said Dr. Dixon. The launch of VIVITROL for the
prevention of relapse to opioid dependence after opioid detoxification, the advancement of its
product candidate pipeline and the potential to apply the companys proprietary technology to the
development of treatments for other significant disease state categories represent significant
growth opportunities for the company. I am very pleased to be joining Alkermes board at such an
exciting time in the companys evolution.
Dr. Dixon also serves on the boards of directors at Furiex Pharmaceuticals, Inc., Orexigen
Therapeutics, Inc. and Incyte Corporation.
About VIVITROL
VIVITROL (naltrexone for extended-release injectable
suspension) 380 mg/vial is the first and
only once-monthly, extended-release injectable medication for the treatment of alcohol
dependence in patients able to abstain from alcohol in an outpatient setting prior to treatment
initiation and for the prevention of relapse to opioid dependence, following opioid detoxification.
Treatment with VIVITROL should be part of a comprehensive management program that
includes psychosocial support. The proprietary Medisorb® drug delivery technology in
VIVITROL enables the medication to be gradually released into the body at a controlled rate
over a one-month time period. The VIVITROL clinical development program was funded in part
with a Small Business Innovation Research Program grant from the National Institute of Drug
Abuse (NIDA). For a copy of the VIVITROL full prescribing information, please visit
www.vivitrol.com or call 1-800-VIVITROL (1-800-848-4876). Please see below for important
safety information, including boxed warning.
VIVITROL IMPORTANT SAFETY INFORMATION
VIVITROL is contraindicated in patients with
acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current
physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed
the naloxone challenge test or has a positive urine screen for opioids, and in patients who have
previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG),
carboxymethylcellulose or any other components of the diluent.
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with
active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing
hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin
at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if
they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of
symptoms and/or signs of acute hepatitis.
VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous
injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must
be injected using one of the customized needles provided in the carton. Because needle length may
not be adequate due to body habitus, each patient should be assessed prior to each injection to
assure that needle length is adequate for IM administration. VIVITROL injections may be followed by
pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases
injection site reactions may be very severe. Injection site reactions not improving may require
prompt medical attention, including in some cases surgical intervention.
Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and
hypoxemia. Patients should be warned of the risk of hypersensitivity reactions, including
anaphylaxis. Opioid-dependent patients including those being treated for alcohol dependence, must
be opioid-free for a minimum of 7-10 days before VIVITROL treatment. Attempts to overcome opioid
blockade due to VIVITROL may result in a fatal overdose. After opioid detoxification, patients are
likely to have reduced tolerance to opioids. Use of lower doses of opioids after VIVITROL is
discontinued, at the end of a dosing interval or after missing a dose could result in life
threatening opioid intoxication. Alcohol- and opioid-dependent patients, including those taking
VIVITROL, should be monitored for the development of depression or suicidal thoughts. As with any
IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any
coagulation disorder. In an emergency situation in patients receiving VIVITROL, suggestions for
pain management include regional analgesia or use of non-opioid analgesics. Patients requiring
reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained
personnel in a setting equipped for cardiopulmonary resuscitation. Caution is recommended in
administering VIVITROL to patients with moderate to severe renal impairment.
The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence
include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and
swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased
appetite or other appetite disorders. The adverse events seen most frequently in association with
VIVITROL in opioid-dependent patients include hepatic enzyme abnormalities, injection site pain,
nasopharyngitis, insomnia, and toothache.
About Alkermes
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative
medicines to improve patients lives. Alkermes developed, manufactures and commercializes
VIVITROL® for alcohol and opioid dependence and manufactures RISPERDAL®
CONSTA® for schizophrenia and bipolar I disorder. Alkermes robust pipeline includes
extended-release injectable and oral products for the treatment of prevalent, chronic diseases,
such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham,
Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing
facility in Ohio. For more information, please visit Alkermes
website at www.alkermes.com.
Forward-Looking Statements
Certain statements set forth above may constitute forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Although the company believes that such
statements are based on reasonable assumptions within the bounds of its knowledge of its business
and operations, the forward-looking statements are neither promises nor guarantees. The companys
business is subject to significant risk and uncertainties and there can be no assurance that its
actual results will not differ materially from its expectations. For information with respect to
risks and uncertainties that could cause the companys actual results to differ materially from
expectations, reference is made to the reports the company filed with the Securities and Exchange
Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements
made in this release are made only as of the date hereof and the
company disclaims any intention or responsibility for updating predictions or expectations
contained in this release.
VIVITROL®
and Medisorb® are trademarks of
Alkermes, Inc. ABILIFY® and REYATAZ®
are trademarks of Bristol-Myers Squibb Company.
SINGULAIR®
and
FOSAMAX®
are trademarks of Merck & Co., Inc.
RISPERDAL® CONSTA® is a trademark of Janssen-Cilag group of companies.
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