Affymax, Inc. (AFFY) Receives $5 Million Milestone Payment from Takeda Pharmaceutical Co. Ltd. (TKDG.DE) on Initiation of Phase 3 Clinical Trials for Hematide in Japan
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq: AFFY - News) 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 HematideTM, 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.
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.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.
This release contains forward-looking statements, including statements regarding the success of the collaboration, timing, design and results of the Company's clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, the cardiovascular event rate in our Phase 3 program, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes 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. The Company undertakes no obligation to update any forward-looking statement in this press release