Affymax, Takeda Announce Emerald Phase 3 Results

Affymax, Inc.

and Takeda Global Research & Development Center, Inc., U.S., today announced results from additional analyses of the EMERALD Phase 3 studies that evaluated the investigational agent peginesatide in dialysis patients with anemia due to chronic kidney disease. The findings, presented at the American Society of Nephrology's Kidney Week, provide further detail on the frequency of adverse events of peginesatide and epoetin alfa or beta, as well as information on the relationship between peginesatide and epoetin doses in the dialysis patients studied, dose requirements of intravenous and subcutaneous peginesatide in patients in the United States and European Union and hemoglobin stability. The companies also presented findings on the rate of Hb decline associated with peginesatide and epoetin following dose discontinuation seen in these studies. “The peginesatide Phase 3 program was one of the most comprehensive clinical programs to support the initial submission of a new drug application (NDA) for an erythropoiesis stimulating agent (

),” said Anne-Marie Duliege, M.D., chief medical officer, Affymax. “We believe these data analyses continue to support peginesatide as a potential agent to treat anemia in the dialysis patient population if approved.”