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Affymax Announces Results From Phase 2 Clinical Trial of Hematide,for the Treatment of Anemia in Dialysis Patients

PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 12, 2007 - Affymax, Inc. (Nasdaq:AFFY) today announced that results available from its Phase 2 clinical trial of Hematide(TM) dosed monthly in dialysis patients were presented this week at the National Kidney Foundation (NKF) 2007 Spring Clinical Meeting. The results from this maintenance-switch trial in patients previously treated with three-times weekly Epoetin Alfa (EPO) demonstrated that mean hemoglobin (Hgb) levels can be maintained at clinically acceptable levels following a switch to once-monthly treatments with Hematide at an appropriate dosing regimen. The data were presented by Anatole Besarab, M.D., adjunct professor of Medicine, Wayne State University and director of Clinical Research at Henry Ford Hospital, Detroit in a poster session at the NKF meeting.

"These data are encouraging and show that patients can be switched from a regimen of EPO three-times weekly to once monthly Hematide in a controlled fashion where hemoglobin levels were maintained within 1 g/dL of baseline at an appropriate dosing regimen," said Dr. Besarab. This is especially important given the growing concerns related to excessive hemoglobin increases due to erythropoiesis stimulating agent use."

"We believe these data support the once per month dosing of Hematide and warrant further investigation in pivotal clinical studies," added Anne-Marie Duliege, M.D., vice president, Clinical, Medical and Regulatory Affairs at Affymax. "Based on the entire Phase 2 data set and as a result of our end of Phase 2 meetings with the Food and Drug Administration (FDA), we are preparing for Phase 3 clinical trials in patients on dialysis and not on dialysis. We are currently in discussions with the FDA on the design of this Phase 3 program."

The Phase 2 trial, which involved 165 patients, was an open label, multi-dose study conducted to assess safety, pharmacodynamics and pharmacokinetics of
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