Affymax, Takeda sales and marketing update

Affymax and partner Takeda voluntarily recalled Affymax's once-monthly anemia drug Omontys peginesatide after receiving new postmarketing reports of serious hypersensitivity reactions that can be life-threatening or fatal. The partners said no new or existing patients should receive Omontys. The recall includes both IV and subcutaneous formulations of Omontys. According to the partners, the overall rate of hypersensitivity reactions is about 0.2% in the more than 25,000 patients that have received Omontys since it 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. Both companies will split the cost of the recall under a 2006 deal to co-develop and co-commercialize peginesatide in the U.S. Takeda has exclusive rights to the product elsewhere (see BioCentury, July 3, 2006 & April 30, 2012). ...