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Affymax Doses First Patient in the Phase 3 Clinical Program of Hematide(TM) to Treat Anemia in Chronic Renal Failure Patients

12 Oct 2007

Affymax, Inc. and Takeda Pharmaceutical Company Limited today announced that Affymax has dosed the first patient in the Phase 3 clinical program of its lead investigational therapy, Hematide(TM), for the treatment of anemia in chronic renal failure patients

PALO ALTO, CA, USA and OSAKA, JAPAN | October 11, 2007 | Affymax, Inc. (Nasdaq:AFFY) and Takeda

Pharmaceutical Company Limited (TOKYO:4502) today announced that Affymax has dosed the first patient in the Phase 3 clinical program of its lead investigational therapy, Hematide(TM), for the treatment of anemia in chronic renal failure patients.

"The initiation of our Phase 3 program for Hematide is a significant milestone for Affymax, which positions us closer to our ultimate goal of providing a convenient monthly treatment alternative to the many patients suffering with anemia," said Arlene M. Morris, president and chief executive officer of Affymax. "We believe our program is uniquely designed to take advantage of the most current regulatory and medical strategies for the evaluation and use of erythropoiesis stimulating agents. Hematide is a novel ESA with the potential to offer monthly dosing to physicians and patients. Consistent with our previous guidance, we anticipate all trials in the Phase 3 renal program will begin enrolling patients by the end of the year with the goal of completing enrollment in each of the trials in 2008. We expect the submission of a New Drug Application for Hematide in chronic renal failure in 2010 if all goes as planned."

"We are very excited with the initiation of the Phase 3 program for Hematide," said Mr. Yasuchika Hasegawa, president of Takeda. "Together with Affymax, we are conducting development activities worldwide in both renal and oncology indications, and we are looking forward to bringing this novel treatment option as soon as possible to patients suffering with anemia."

The Hematide Phase 3 program, involving a total of approximately 2,200 chronic renal failure patients, consists of four open-label, randomized controlled clinical trials in the U.S. and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The trials in non-dialysis patients, called PEARL 1 and PEARL 2, will evaluate the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. In dialysis patients previously-treated with EPO, the trials, called EMERALD 1 and EMERALD 2, will evaluate the safety and efficacy of Hematide and its ability to maintain hemoglobin levels in a corrected range compared to epoetin alpha or epoetin beta when patients are switched from either of these epoetins to Hematide. Analysis of efficacy for each study will be based on assessments of non-inferiority to the comparator drugs. The primary efficacy endpoint will be the mean change in hemoglobin from baseline. The hemoglobin target range will be 11-12 g/dL for studies in non-dialysis patients and 10-12 g/dL for studies in dialysis patients. In all studies, Hematide will be dosed once every four weeks while comparator drugs will be dosed in accordance with their respective product labels. Treatment in each study will be continued until the last patient has been treated for 52 weeks. Assessment of safety will include an analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from all four Phase 3 trials.

About Hematide

Hematide is a novel synthetic, pegylated peptidic compound that binds to and activates the erythropoietin receptor and acts as an erythropoiesis stimulating agent. The product is being developed for treatment of anemia in patients with chronic renal failure and cancer patients receiving chemotherapy.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide(TM), is currently being evaluated in Phase 3 clinical trials for the treatment of anemia associated with chronic renal failure and is in clinical trials for the treatment of chemotherapy-induced anemia in cancer patients. For additional information, please visit www.affymax.com.

About Takeda

Located in Osaka, Japan, Takeda (TOKYO:4502) 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 striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.

This release contains forward-looking statements, including statements regarding the 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, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company's Quarterly Report on Form 10-Q 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.

SOURCE: Affymax, Inc.

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