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Takeda Pharmaceuticals U.S.A. (TPUSA) and Affymax, Inc. (Nasdaq:AFFY) today announced that Takeda Pharmaceuticals America, Inc. (TPA) has entered into a supply agreement for sourcing and supply of OMONTYS
®(peginesatide) Injection to Fresenius Medical Care North America and certain of its affiliates. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the dialysis patient population with chronic kidney disease (CKD) in the United States.
The agreement, which ends in April 2013, allows Fresenius Medical Care North America to purchase OMONTYS for use in U.S. centers within its organization and provides for discounts and rebates on the product, subject to certain requirements. Fresenius Medical Care North America has stated that its initial plans are to adopt the product into more than 100 dialysis centers in the U.S. over the next few weeks, and then, based on its experience, evaluate the potential to expand to additional centers. Financial terms were not disclosed.
“We are excited to partner with Fresenius Medical Care North America, one of the world’s leading dialysis providers, to offer a new therapeutic option for the treatment of anemia in its chronic kidney disease patients on dialysis,” said Nicole Mowad-Nassar, vice president, marketing at Takeda.
“As a biotechnology company dedicated to advancing new therapies for renal diseases, Affymax shares Fresenius Medical Care North America’s commitment to innovation,” stated John Orwin, chief executive officer of Affymax. “We are very pleased to support Fresenius Medical Care in these efforts to integrate OMONTYS into its organization and to collaborate with them moving forward.”
OMONTYS was approved by the FDA on March 27, 2012, for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is not indicated, and is not recommended, for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life. Please see Important Safety Information including
Boxed WARNINGS below.
® (peginesatide) Injection is a synthetic, pegylated, peptide-based ESA. It is the only ESA that is peptide-based and its building blocks (amino acids) are arranged in a different order than erythropoietin (i.e., it has no sequence homology to endogenous erythropoietin).
On March 27, 2012, the United States Food and Drug Administration approved OMONTYS for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to this patient population in the United States.