Alkermes Announces Submission of New Drug Application for Vivitrex for

    Pharmaceutical Writers/Business Editors/Health/Medical Writers

    CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 1, 2005--Alkermes, Inc. (Nasdaq: ALKS) today announced that the Company has submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for marketing approval of Vivitrex(R) (naltrexone long-acting injection), an investigational drug in development for the treatment of alcohol dependence. If approved, Vivitrex would be the first medication available for the treatment of alcohol dependence in a formulation that is administered once-monthly by injection.
    "This NDA submission is a major milestone in our Vivitrex development program, which comprises a comprehensive U.S. clinical trials program, manufacturing infrastructure and extensive regulatory and research expertise," commented Richard Pops, chief executive officer of Alkermes. "I'd like to take this opportunity to congratulate the many employees at Alkermes who built and integrated these capabilities and made this regulatory filing possible."
    Vivitrex, an injectable, long-acting formulation of the currently approved drug naltrexone, was designed utilizing Alkermes' proprietary Medisorb(R) drug-delivery technology. Using the Medisorb technology, naltrexone is encapsulated in microspheres made of a biodegradable polymer that dissolve slowly and release drug at a controlled rate following intramuscular injection.

    About Alcohol Dependence

    In the U.S., approximately 18 million people are dependent on or abuse alcohol(1) and 2.3 million adults seek treatment each year(2). Taking prescribed medication, an important determinant in therapeutic outcomes(3), is particularly challenging for patients with addictive disorders such as alcohol dependence(4). Alcohol is causally related to more than 60 medical conditions, including heart disease, liver disease, infectious disease, and cancer(5),(6), and contributes to more than 100,000 deaths in the U.S. each year(7). In addition, alcohol dependence accounts for approximately $134 billion in lost earnings annually(8).

    About Alkermes, Inc.

    Alkermes, Inc. is a pharmaceutical company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases. The Company's lead commercial product, Risperdal Consta(R) ((risperidone) long-acting injection), is the first and only long-acting atypical antipsychotic medication approved for use in schizophrenia, and is marketed worldwide by Janssen-Cilag ("Janssen"), a wholly owned subsidiary of Johnson & Johnson. The Company's lead proprietary product candidate, Vivitrex(R) (naltrexone long-acting injection), is being developed as a once-monthly injection for the treatment of alcohol dependence. The Company has a pipeline of extended-release injectable products and pulmonary drug products based on its proprietary technology and expertise. Alkermes' product development strategy is twofold: the Company partners its proprietary technology systems and drug delivery expertise with several of the world's finest pharmaceutical companies and it also develops novel, proprietary drug candidates for its own account. The Company's headquarters are in Cambridge, Massachusetts, and it operates research and manufacturing facilities in Massachusetts and Ohio.

    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 and the Company's 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 further information with respect to factors that could cause the Company's actual results to differ 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 financial guidance contained in this release.

    (1)Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC and
    Pickering RP. The 12-month prevalence and trends in DSM-IV
    alcohol abuse and dependence: United States, 1991-1992 and
    2001-2002. Drug and Alcohol Dependence 2004; 74: 223-234.

    (2)Alkermes Forecasting Data 2005.

    (3)Weiss RD. Adherence to pharmacotherapy in patients with alcohol
    and opioid dependence. Addiction 2004; 99: 1382-1392.

    (4)Rinn W, Desai N, Rosenblatt H, Gastfriend DR. Addiction denial
    and cognitive dysfunction: A preliminary investigation. J
    Neuropsychiatry Clin Neurosci 2002; 14: 52-57.

    (5)Room R, Babor T, Rehm J. Alcohol and public health. Lancet
    2005; 365: 519-530.

    (6)Bagnardi V; Blangiardo M; Vecchia C, et al. Alcohol consumption
    and the risk of cancer. Alcohol Res Health 2001; 25(4):
    263-270.

    (7)McGinnis JM, Foege WH. Mortality and morbidity attributable to
    use of addictive substances in the United States. Proc Assoc.
    Am. Physicians. 1999; 111:109-118.

    (8)US DHHS: The Economic Costs of Alcohol and Drug Abuse in the
    United States: Estimates, Update Methods, and Data, 2000.

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CONTACT: Alkermes, Inc. Investor Relations: Jaren Madden 617-583-6402 or Media Relations: Barbara Yates Alkermes, Inc. 617-583-6321

KEYWORD: MASSACHUSETTS INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY PRODUCT SOURCE: Alkermes, Inc.

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