Takeda Pharmaceuticals U.S.A., Inc. (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 with DSI Renal, one of the largest dialysis providers in the United States (U.S.). OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the adult dialysis patient population with chronic kidney disease (CKD) in the U.S.
The agreement allows DSI Renal to purchase OMONTYS for use within its organization and provides for discounts and rebates on the product, subject to certain requirements. DSI Renal has indicated that they plan to initially evaluate OMONTYS in selected centers, and then, based on experience, evaluate the potential to expand to additional centers. Financial terms were not disclosed.
“We look forward to working with DSI Renal as they integrate OMONTYS into their dialysis centers,” stated John Orwin, chief executive officer of Affymax. “With this agreement, we now have supply agreements in place with five out of the six medium-sized dialysis organizations in the U.S.”
OMONTYS was approved by the U.S. Food and Drug Administration (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.About OMONTYS OMONTYS ® (peginesatide) Injection is a synthetic, pegylated 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 FDA approved OMONTYS for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is the first ESA to be introduced to the U.S. market in over 10 years. It is the only once-monthly ESA for anemia available to this patient population in the U.S.