Nektar Reports Affymax Announced 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 (NASDAQ:NKTR) today reported that its partner Affymax, Inc. announced that the U.S. Food and Drug Administration (FDA) Oncologic...

SAN FRANCISCO , Dec. 8, 2011 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR ) today reported that 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.

Nektar's technology has enabled seven approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia ® for Crohn's disease and rheumatoid arthritis, Pfizer's Somavert ® for acromegaly, Roche's MIRCERA ® for anemia, Roche's PEGASYS ® for hepatitis C, and Amgen's Neulasta ® for neutropenia.

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 .

About Peginesatide

Peginesatide is a synthetic PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The compound was discovered by Affymax and is being co-developed by Affymax and Takeda Pharmaceutical Company Limited. The peginesatide Phase 3 clinical program was the largest to support the new drug application of an ESA in the treatment of anemia in CKD and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events. If approved, peginesatide may be the first once-monthly product for anemia in CKD for dialysis patients available in the United States .

About Nektar Therapeutics

Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for NKTR-118, an investigational drug candidate, being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation. The agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of NKTR-118 and an opioid. NKTR-181, a novel mu-opioid analgesic molecule, has completed Phase 1 single and multiple dose clinical studies, and is being prepared to start Phase 2. In oncology, NKTR-102, a novel topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of breast, ovarian and colorectal cancers.

Nektar is headquartered in San Francisco, California , with additional R&D operations in Huntsville, Alabama and Hyderabad, India . Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com .

Forward-Looking Statements

SOURCE Nektar Therapeutics