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Affymax's Peginesatide May Be Tough Sell To ODAC As ESAs Cast Long Showdow

This article was originally published in The Pink Sheet Daily

Executive Summary

Safety concerns over erythropoiesis-stimulating agents seem to extend to Affymax's peginesatide, and since it lacks an efficacy edges over these drugs in treating anemia due to chronic kidney disease, an approval basis is unclear.

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Medicare’s bundling policy for drugs and services in dialysis has turned on the pricing pressure in kidney disease. The cost containment policies have negatively impacted sales of some drugs and put a spotlight on growing costs in chronic kidney disease and end-stage renal disease. Nonetheless, there is plenty of opportunity for new drugs that can address the area’s unmet medical need, especially if they can help to reduce broader health care spending. That will require demonstrating value to payors and providers, however, particularly for drugs that treat secondary conditions associated with kidney disease.

ESRD Market Snapshot: The Price Has To Be Right

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With FDA’s March 27 approval of peginesatide to prevent anemia in CKD patients on dialysis, Affymax will focus initially on marketing to smaller, price-conscious dialysis providers. But the biotech also expects to do business with Fresenius and, to a lesser degree, Davita.

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