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 with U.S. Renal Care, Inc. and certain of its affiliates, representing one of the top 10 dialysis providers in the United States (U.S.). 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 U.S. The agreement allows U.S. Renal Care to purchase OMONTYS for use within its organization and provides for discounts and rebates on the product, subject to certain requirements. U.S. Renal Care 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. “As we anticipated, there is interest from some of the world’s leading dialysis providers to offer a new therapeutic option for the treatment of anemia in chronic kidney disease patients on dialysis,” said Nicole Mowad-Nassar, vice president, marketing at Takeda. “These centers are demonstrating an interest in offering new therapies and showing their commitment to innovation,” stated John Orwin, chief executive officer of Affymax. “We intend to support their integration efforts and believe OMONTYS will prove to be a once-monthly alternative in their centers 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. About OMONTYS OMONTYS ® (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.
About Anemia Due to CKD in Adult Patients on DialysisAnemia is a complication of CKD and is associated with cardiovascular illness and mortality. As of 2009, the United States Renal Data System noted there were nearly 400,000 people in the United States who were on dialysis. IMPORTANT SAFETY INFORMATION WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE. Chronic Kidney Disease: • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. • No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. • Use the lowest OMONTYS dose sufficient to reduce the need for red blood cell (RBC) transfusions. Contraindications OMONTYS is contraindicated in patients with uncontrolled hypertension. Warnings and Precautions Increased mortality, myocardial infarction, stroke, and thromboembolism:
- Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit. Use caution in patients with coexistent cardiovascular disease and stroke. Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of >1 g/dL over 2 weeks may contribute to these risks
- In controlled clinical trials of ESAs in patients with cancer, increased risk for death and serious adverse cardiovascular reactions was observed. These adverse reactions included myocardial infarction and stroke
- In controlled clinical trials of ESAs, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and deep venous thrombosis (DVT) in patients undergoing orthopedic procedures
- In 2 trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events