Vivitrol

naltrexone

FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence

Alkermes and Cephalon Continue to Anticipate Product Launch in Second Quarter 2006

CAMBRIDGE, Mass.& FRAZER, Pa.--(BUSINESS WIRE)--December 28, 2005 - Alkermes, Inc. (Nasdaq: ALKS) and Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Vivitrol(TM) (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support. The New Drug Application (NDA) for Vivitrol, formerly known as Vivitrex, was submitted on March 31, 2005. Alkermes and Cephalon continue to prepare for the launch of Vivitrol during the second quarter of 2006.

FDA approval of Vivitrol is contingent upon finalizing the product label and satisfying a request by the FDA for preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data. Vivitrol was filed as a 505(b)(2) NDA application, permitting Alkermes to reference results of studies that were previously submitted to the FDA in support of the original oral naltrexone NDA.

"This approvable letter is a positive step toward the approval of Vivitrol," stated Richard Pops, CEO of Alkermes. "We look forward to working diligently with the FDA to gain final approval and bring forward Vivitrol as an important new medication for the treatment of alcohol dependence."

"Our plans for the launch of Vivitrol in the second quarter of 2006 are on track," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon. "We are hiring sales representatives and designing education and training programs to ensure that physicians and counselors can identify patients who could benefit the most from the inclusion of this medication in their treatment plan."

Source: Alkermes, Inc.

Related Articles:

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 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

Alkermes Announces Submission of New Drug Application for Vivitrex for Treatment of Alcohol Dependence - April 1, 2005

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