Alkermes, Cephalon receive conditional FDA approval for Vivitrol

12/29/05 - newratings.com

NEW YORK, December 29 (newratings.com) – Alkermes Inc (ALKS) and Cephalon Inc (CEPH) announced late Wednesday that the US Food and Drug Administration (FDA) had given a conditional approval for their anti-alcoholism drug, Vivitrol.

The Cambridge, Massachusetts-based biotech company said that Vivitrol, formerly known as Vivitrex, would be available in the market in the second quarter of 2006. Alkermes plans to market the drug with its partner Cephalon, which specializes in the marketing of neurological drugs. While granting an approvable letter, the FDA has asked Alkermes for additional clinical data relating to Vivitrex.

Alkermes has been marketing a form of the drug as a once-a-day pill, known as naltrexone, for the treatment of alcoholism. Vivitrol is a long-acting formulation, which the two biotechnology companies want to market as a once-a-month injection. Forbes quoted Credit Suisse First Boston analyst Ken Kulju as saying Vivitrol’s end sales are estimated to reach $30 million in 2006, and ramp up to about $77 million in 2007.

Alkermes' share price jumped $1.35 to $19.14 on the NASDAQ on Thursday, while Cephalon's share price rose $0.35 to $65.02.