Takeda to withdraw NDA as Omontys pact with Affymax ends

USA-based Affymax (Nasdaq: AFFY) and Japan's Takeda Pharmaceutical (TYO: 4502) revealed on Friday that they have terminated their Omontys (peginesatide) product collaboration and license agreement, which will terminate effective September 10, 2014.

In February last year,  Affymax and Takeda voluntarily recalled all lots of the anemia drug Omontys and suspended promotional activities in the USA following post-marketing reports of serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal.

Takeda has conducted a detailed investigation of these reactions. This has confirmed no quality or manufacturing issues were present but has not identified a specific root cause for the reactions that were observed. A total of 98 adverse events tied to the drug were reported to the US Food and Drug Administration, including 12 deaths, by February 22, 2013, the day before the recall.