Affymax Inc. and Takeda Pharmaceutical Company Ltd. said they would terminate their Omontys product collaboration in September. The companies also said they will withdraw their new drug application with the U.S. Food and Drug Administration.
The companies recalled the anemia drug for dialysis patients in February 2013 following reports of serious hypersensitivity reactions including anaphylaxis. Ninety-eight adverse events tied to the drug were reported to the FDA. An investigation has confirmed no quality or manufacturing issues were present, but it has not identified a specific root cause for the reactions that were observed.
Affymax said its board of directors is reviewing its strategic options. Takeda said this termination does not change the outlook for its consolidated results for fiscal 2014.