alkerms

a competitor in this market just started up in Russia. Seems they have some problems...

FDA warning on Alkermes alcoholism drugBoston Business Journal...
A drug to treat alcoholism developed by Alkermes Inc. has caused blood clots, swelling, abscesses, cell death and other adverse reactions in nearly 200 cases, according to a warning for health care professionals issued Tuesday by the U.S. Food and Drug Administration.

The FDA, in the warning posted on its Web site, said it has received 196 reports of injection site reactions from the drug Vivitrol including cellulitis, blood clots, abscesses, and necrosis (cell death).

Of those reports, 16 patients needed surgery to facilitate their treatment.

An Alkermes spokeswoman said Alkermes and U.S. marketing partner Cephalon Inc. "are committed to ensuring that Vivitrol is used safely and effectively and providing patients with the most current information on the treatment. While injection site reactions have occurred, they have been rare. We will continue to work with regulatory agencies to monitor any adverse events and ensure Vivitrol is a safe and (effective) treatment option for alcohol dependence."

The company’s stock traded at $16.49 early Tuesday afternoon, down about 2.4 percent.

Cephalon Inc. markets the drug in the United States for Cambridge, Mass.-based Alkermes (Nasdaq: ALKS).

Alkermes recently inked a deal with a Johnson & Johnson subsidiary to market Vivitrol in Russia.