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news.Affymax has received a $5m development milestone payment from Takeda Pharma as part of its exclusive global agreement to develop and commercialize investigational drug Hematide for the treatment of anemia in chronic renal failure patients.
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Affymax said that the milestone was achieved with the initiation of Phase 3 clinical testing of Hematide to treat anemia in chronic renal failure patients in Japan. Hematide is a 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 will co-commercialize the product in the US. Takeda holds an exclusive license to develop and commercialize Hematide outside the US, including Japan. 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.
Reportedly, in January, Affymax has announced the completion of treatment and follow-up of patients enrolled in the four-trial, Phase 3 clinical program for Hematide in the US. The company expects to report topline results from these trials in the second quarter of 2010. The US Phase 3 clinical program enrolled approximately 2,600 chronic renal failure patients at approximately 400 clinical trial sites.