A Mystery About Affymax & Its Anemia Drug Recall

Late yesterday, the FDA disclosed that Affymax and its marketing partner, Takeda Pharmaceuticals, issued a so-called voluntary recall of their Omontys medication, which is used to treat anemia in adult dialysis patients, after there were 19 reports of anaphylaxis, a serious and life-threatening allergic, at dialysis centers in the US. Three of the cases ended in death and several other patients required hospitalization (here is the FDA statement). Not surprisingly, the recall is killing Affymax (AFFY) stock, since the drugmaker was hoping to penetrate a huge market dominated by billion-dollar-sellers such as Epogen and Aranesp, which are sold by Amgen (AMGN), as well as Procrit, which is marketed by Johnson & Johnson (JNJ). Given that Omontys is the only drug that Affymax currently sells, its shares plunged about 85 percent in pre-market trading this morning and, as of 11 am EST, have yet to recover. However, a conference call this morning is unlikely to assuage investor pain, at least those who were not shorting the stock. The Affymax team noted that serious hypersensitivity occurred with intravenous administration about 3 minutes after a first dose, suggesting long-term use may not be an issue. But they have been unable to prospectively determine which patients may have such a reaction. So far, by the way, about 25,000 people have been given Omontys. So far, actual usage has yielded a hypersensitivity rate of .2 percent with about one-third of patients considered serio...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Affymax Amgen Anemia Aranesp Biosimilars Epogen FDA JJ Johnson & Johnson Omontys Procrit Takeda Pharmaceuticals Source Type: blogs