Commercial Products
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Website www.alkermes.com Ticker Symbol (NASDAQ) ALKS Alkermes, Inc. is a fully integrated biotechnology company that develops medicines designed to yield better outcomes Contacts and improve patients’ lives. Our products, which use novel molecules and innovative drug technologies, target Rebecca Peterson Vice President, Corporate widespread diseases including central nervous system (CNS) disorders, addiction and diabetes. We approach the drug Communications development process from a patient-centric perspective, beginning with a thorough understanding of the challenges Voice: 617-583-6378 patients face on a day-to-day basis. Our products are designed with patient needs and behaviors in mind, with the goal Blair Jackson of ensuring that patients consistently take their medication for long-term treatment success. Vice President, Business Development Alkermes has multiple partnered programs and also works independently to develop and commercialize proprietary Voice: 617-250-1594 products. The company has built a wide range of capabilities, including innovative research programs, clinical development, large-scale manufacturing, and a commercial presence in the marketplace. Corporate Headquarters Alkermes, Inc. 88 Sidney Street Cambridge, MA 02139 VIVITROL® Voice: 617-494-0171 Commercial Products (naltrexone for extended-release injectable suspension) Fax: 617-494-9263 RISPERDAL® CONSTA® [(risperidone) long-acting injection] Product: VIVITROL is an injectable formulation of naltrexone, based on Alkermes’ unique Medisorb Product: RISPERDAL CONSTA is a long-acting injectable technology. VIVITROL is designed for once-monthly form of Johnson & Johnson’s schizophrenia drug, dosing, eliminating the need for patients to make a RISPERDAL. Developed utilizing Alkermes’ proprietary daily decision about taking their medicine. Alkermes Medisorb® technology, RISPERDAL CONSTA is manufactures VIVITROL at its commercial facility in Ohio administered once every two weeks, rather than daily, and markets the product independently in the U.S. with for the management of schizophrenia. a focused commercial team. In Russia, Janssen-Cilag, Status: Johnson & Johnson’s subsidiary, Janssen, markets an affiliate company of Cilag GmbH International, is RISPERDAL CONSTA worldwide. It is approved for sale in responsible for the commercialization of VIVITROL. more than 80 countries, including the U.S., the United Status: VIVITROL has been commercially available for Kingdom and Germany. the treatment of alcohol dependence in the U.S. since Market Opportunity: Schizophrenia is a brain disorder June 2006 and will be available in Russia in 2009. that affects 1-2% of the world’s population. Until now, Market Opportunity: Approximately 18 million people extended-release injection formulations of antipsychotics in the United States are dependent on or abuse alcohol have been available only for older, typical treatments. and half of these individuals are alcohol dependent. Additional Developments: The U.S. Food and Drug An estimated 2.2 million people seek treatment for Administration (FDA) is currently reviewing RISPERDAL alcohol problems each year. CONSTA for the treatment of bipolar disorder. Alkermes Additional Developments: Alkermes is currently and Johnson & Johnson are also developing a four-week developing VIVITROL for the treatment of opioid formulation of RISPERDAL CONSTA. dependence. For product information, please visit www.risperdalconsta.com. For product information, please visit www.vivitrol.com. Management Clinical Development Programs Team Preclinical Phase I Phase II Phase III Regulatory Review Approved David A. Broecker President and Chief Executive Officer RISPERDAL® CONSTA® (Schizophrenia) Kathryn L. Biberstein Senior Vice President RISPERDAL® CONSTA® (Bipolar Disorder) and General Counsel ® Madeline D. Coffin VIVITROL (Alcohol Dependence) Vice President Human Resources VIVITROL® (Opioid Dependence) Elliot W. Ehrich, M.D. Senior Vice President Exenatide Once Weekly (Diabetes) Research and Development and Chief Medical Officer ALKS 27 (COPD) James M. Frates Senior Vice President Chief Financial Officer ALKS 29 (Alcohol Dependence) Michael J. Landine Senior Vice President ALKS 33 (Addiction) Corporate Development Gordon G. Pugh Senior Vice President and Development Candidates important role for the treatment of diseases in which Chief Operating Officer the extended-release formulation of a drug may help In collaboration with Amylin Pharmaceuticals, Inc. and to improve outcomes. Eli Lilly and Company, we are developing exenatide once weekly, an extended-release formulation that contains the Pulmonary Drug Delivery ® same active ingredient as BYETTA® injection. BYETTA is a The AIR pulmonary drug delivery technology offers a first-in-class injectable medication for the treatment of type unique, proprietary delivery system for optimized drug 2 diabetes that is administered twice-daily. delivery to the lungs. The inhaler is designed to be small and easy to use, with the ability to effectively deliver In addition, we are developing ALKS 27, an inhaled consistent doses of medication. treatment for obstructive pulmonary disease (COPD) that leverages our proprietary AIR® technology to deliver Manufacturing medication using a small, simple inhaler. We are also developing ALKS 29 and ALKS 33 for the treatment With it's world class commercial manufacturing facility, of addiction. Alkermes is well-positioned to support the development, launch and commercialization of its product candidates. Proprietary Technology A 200,000 square foot cGMP manufacturing facility in Wilmington, Ohio, provides commercial scale Injectable Extended-Release manufacturing for extended-release products. Alkermes’ injectable extended-release drug delivery RISPERDAL CONSTA and VIVITROL are produced system is clinically proven and currently manufactured at this location. at commercial levels. This technology can play an Alkermes, Inc. 88 Sidney Street Cambridge, Massachusetts 02139-4136 USA Tel: 617 494-0171 Fax: 617 494-9263 www.alkermes.com AIR® and Medisorb® are registered trademarks of Alkermes, Inc.; BYETTA® is a trademark of Amylin Pharmaceuticals, Inc.; VIVITROL® is a trademark of Cephalon, Inc.; RISPERDAL® CONSTA® is a registered trademark of Johnson & Johnson Corporation. rev. 12/08.