Nektar Therapeutics And Affymax, Inc. Reports FDA Advisory Committee Voted In Favor of Benefit/Risk Profile For Peginesatide For Treatment of Anemia In Chronic Kidney Disease Patients On Dialysis

Nektar Therapeutics and its partner Affymax, Inc. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD). Nektar and Affymax have an exclusive agreement under which Nektar provides Affymax with its proprietary PEGylation technology for use in peginesatide. Under the terms of the agreement, Nektar receives manufacturing revenue, milestone and other payments, and is entitled to receive royalties on the global sales of peginesatide for all indications. While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted by Affymax, Inc. for peginesatide in May 2011 . The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012 .