Vivitrol

Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence

CAMBRIDGE, Mass., Apr 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 (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 alcohol¹ and 2.3 million adults seek treatment each year². Taking prescribed medication, an important determinant in therapeutic outcomes³, is particularly challenging for patients with addictive disorders such as alcohol dependence⁴. 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 year⁷. In addition, alcohol dependence accounts for approximately $134 billion in lost earnings annually⁸.

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 ((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 (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.

References:

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.

Posted: April 2005

Related Articles

• FDA Approves Vivitrol to Treat Opioid-dependent Patients - October 13, 2010
• Vivitrol Approved - Alkermes Inc. and Cephalon Inc - Treatment for Alcohol Dependence - April 13, 2006
• Alkermes Announces Submission of Complete Response to FDA for Vivitrol New Drug Application - February 17, 2006
• FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence - December 28, 2005
• FDA Extends PDUFA Date for Vivitrex to December 30, 2005 - September 20, 2005
• Alkermes Announces Priority Review Granted For Vivitrex (Naltrexone Long-Acting Injection) NDA Submission - May 27, 2005

Vivitrol (naltrexone) FDA Approval History

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