Affymax plummets on Omontys recall

Affymax Inc. (NASDAQ:AFFY) plummeted $14.10 (85%) to $2.42 on Monday after the company and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) announced a voluntary recall of Affymax's once-monthly anemia drug Omontys peginesatide. The move translates to a loss in Affymax's market cap of $524 million for a closing valuation of $89.9 million. The partners, who said no new or existing patients should receive Omontys, said the recall is a result of new postmarketing reports of serious hypersensitivity reactions that can be life-threatening or fatal. The recall includes both IV and subcutaneous formulations of Omontys.

The partners said the overall rate of hypersensitivity reactions is about 0.2% in the more than 25,000 patients that have received Omontys since the drug was launched last April. All cases of serious hypersensitivity reactions were reported following the first dose of IV Omontys, with no reported cases following subsequent doses or in patients who received subcutaneous Omontys. According to FDA, there have been 19 cases of anaphylaxis with Omontys, including three deaths due to serious anaphylactic reactions. Affymax and Takeda are investigating the cause, but on a conference call to discuss the recall Affymax said it is "premature" to speculate on next steps. ...