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The Future Of ESAs – Is It All CKD Now?

This article was originally published in The Pink Sheet Daily

Executive Summary

Takeda and Affymax revise Hematide program to stop development for chemotherapy-induced anemia and focus on anemia related to chronic kidney disease.

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Phase III for Affymax's ESA Hematide to finish by year-end

Phase III trials of Affymax/Takeda's erythropoiesis-stimulating agent Hematide will wrap-up by year-end, Affymax announced Sept. 9. The 400 clinical trial sites will complete treatment of patients by the end of 2009, a timeline allowed due to the firms securing of $42 million in private and public financing in February (1"The Pink Sheet" DAILY, Feb. 17, 2009). The Phase III program includes 2,600 chronic renal failure patients enrolled in four open-label non-inferiority trials. Two of the trials are in patients on dialysis, and are evaluating Hematide's ability to maintain hemoglobin levels in the target range when patients are switched from epoetin alfa or epoetin beta. The other two trials are in patients not on dialysis, and are comparing Hematide to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. The controversy over safety problems with ESAs for chemotherapy-induced anemia caused the firms to suspend development last year of Hematide for that population (2"The Pink Sheet" DAILY, Aug. 29, 2008). The companies expect to report top-line results and file the NDA in 2010

Phase III for Affymax's ESA Hematide to finish by year-end

Phase III trials of Affymax/Takeda's erythropoiesis-stimulating agent Hematide will wrap-up by year-end, Affymax announced Sept. 9. The 400 clinical trial sites will complete treatment of patients by the end of 2009, a timeline allowed due to the firms securing of $42 million in private and public financing in February (1"The Pink Sheet" DAILY, Feb. 17, 2009). The Phase III program includes 2,600 chronic renal failure patients enrolled in four open-label non-inferiority trials. Two of the trials are in patients on dialysis, and are evaluating Hematide's ability to maintain hemoglobin levels in the target range when patients are switched from epoetin alfa or epoetin beta. The other two trials are in patients not on dialysis, and are comparing Hematide to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. The controversy over safety problems with ESAs for chemotherapy-induced anemia caused the firms to suspend development last year of Hematide for that population (2"The Pink Sheet" DAILY, Aug. 29, 2008). The companies expect to report top-line results and file the NDA in 2010

Affymax Swings $42 Million Financing To Push Hematide

Private/public infusion will see synthetic ESA through trials and approval.

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