Affymax Receives a $50 Million Milestone Payment for U.S. Approval of OMONTYS® (peginesatide) Injection
PALO ALTO, Calif., Apr 09, 2012 (BUSINESS WIRE) -- Affymax, Inc. AFFY -0.31% today announced that it has received a $50 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize OMONTYS® (peginesatide) Injection. The milestone was triggered by the U.S. Food and Drug Administration (FDA) approval of OMONTYS on March 27, 2012.
This is in addition to the $5 million milestone payment the company received from Takeda that was triggered by the European Medicines Agency acceptance of the Marketing Authorization Application in February.
About Affymax and Takeda Partnership
In 2006, Affymax, Inc. and Takeda Pharmaceutical Company Limited entered into an exclusive global agreement to collaborate on the development and commercialization of OMONTYS. Both companies are working together to co-commercialize OMONTYS in the U.S., while Takeda holds an exclusive license to develop and commercialize the product outside the U.S.
Based on the acceptance of a Marketing Authorization Application (MAA) submitted by Takeda, peginesatide is currently under review by the European Medicines Agency (EMA) for the treatment of symptomatic anemia associated with chronic kidney disease in adult patients on dialysis.
Takeda and Affymax are exploring options for the commercialization rights for peginesatide in the Japanese market, including potentially licensing to a third party.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California. Affymax's mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses.
The company's first marketed product, OMONTYS, was approved by the U.S. Food and Drug Administration (FDA) in March 2012. For additional information on Affymax, please visit www.affymax.com .
This release contains forward-looking statements, including statements regarding the continuation and success of our collaboration with Takeda, the timing and potential for the EMA approval of the MAA in Europe and the commercialization of OMONTYS. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the EMA approval of the MAA, risks relating to regulatory requirements required by the FDA, the EMA or other regulatory authorities, including post-marketing studies, trials and Risk Evaluation and Mitigation Strategy (REMS), industry and competitive environment, financing requirements and our ability to access capital and other matters that are described in Affymax's Annual Report on Form 10-K filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.
SOURCE: Affymax, Inc.
Affymax, Inc.Sylvia WheelerVice President, Corporate Communications650-812-8861