Affymax(R) Receives $5 Million Milestone Payment On Initiation Of Phase 3 Clinical Trials For Hematide™ In Japan

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Mar 2010 - 0:00 PST

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Affymax, Inc. (Nasdaq: AFFY) today announced that it has received a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize Hematide™, Affymax's investigational drug for the treatment of anemia in chronic renal failure patients. The milestone was achieved with the initiation of Phase 3 clinical testing of Hematide to treat anemia in chronic renal failure patients in Japan.

Affymax and Takeda are collaborating on the development of Hematide and will co-commercialize the product in the United States. Takeda holds an exclusive license to develop and commercialize Hematide outside the United States, including Japan.

In January, Affymax announced the completion of treatment and follow-up of patients enrolled in the four-trial, Phase 3 clinical program for Hematide in the U.S. The company expects to report topline results from these trials in the second quarter of 2010. The U.S. Phase 3 clinical program enrolled approximately 2,600 chronic renal failure patients at approximately 400 clinical trial sites.

About Hematide

Hematide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA).

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for Hematide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized in the European Union and Japan by Takeda.

Source
Affymax, Inc.