Monday, August 4, 2008

Russia says ‘da’ to Alkermes’ Vivitrol

By Mass High Tech Staff

Alkermes Inc.’s alcohol dependence drug Vivitrol has been approved by Russian regulatory authorities. Vivitrol is a once-monthly, extended-release injectable suspension formulation of naltrexone, developed using Alkermes’ Medisorb technology.

Alkermes (Nasdaq: ALKS) is partnering with Belgium-based Janssen-Cilag, a Johnson & Johnson company. The Cambridge-based biotech will manufacture Vivitrol for Janssen-Cilag, which will sell the drug in Russia. Besides revenues from manufacturing the drug, Alkermes will receive royalties based on its sales.

Financial details of the Janssen-Cilag deal were not released. In the U.S., Vivitrol is marketed primarily by Frazer, Pa.-based Cephalon Inc.

According to Janssen-Cilag, approximately 10 million people are dependent on alcohol in Russia. Because its abuse has been “causally related” to myriad diseases including cancer, heart disease and liver disease, it has been identified as contributing to 30 percent of all deaths in the country per year, the company stated.

In June, Alkermes reported its start of a Phase 3 clinical trial of its Vivitrol long-term treatment for opioid dependence. Alkermes employs 610 workers and reported 2008 net income of $167 million on revenue of $240.7 million.