Affymax, Inc. and Takeda Pharmaceutical Company Limited (Takeda) Osaka,
Japan (June 16, 2014) announced today that their Omontys®
(peginesatide) product collaboration and license agreement will
terminate effective September 10, 2014.
In February 2013, Affymax and Takeda voluntarily recalled all lots of
Omontys and suspended promotional activities in the U.S. following
postmarketing reports of serious hypersensitivity reactions including
anaphylaxis, which may be life-threatening or fatal.
Takeda has conducted a detailed investigation of these reactions. The
investigation has confirmed no quality or manufacturing issues were
present but has not identified a specific root cause for the reactions
that were observed.
Based on these findings and related discussions with Takeda, Affymax has
elected not to exercise its rights with respect to the Omontys New Drug
Application (NDA). Takeda will work with the U.S. Food and Drug
Administration to withdraw the Omontys NDA.
The Board of Directors of Affymax is reviewing its strategic options as
a result of the termination of the collaboration with Takeda.
This termination does not change the outlook for Takeda's consolidated
results for fiscal 2014.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Cupertino,
California. For additional information, please visit www.affymax.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for people worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
Copyright Business Wire 2014