Affymax, Inc.Sylvia WheelerVice President, Corporate Communications650-812-8861orTakeda Pharmaceuticals U.S.A., Inc.Elissa JohnsenCorporate Communications224-554-3185
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 below.
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.
Anemia 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.
OMONTYS is contraindicated in patients with uncontrolled hypertension.
The safety and efficacy of OMONTYS have not been established for use in patients with anemia due to cancer chemotherapy. OMONTYS is not indicated in patients with cancer receiving chemotherapy.
OMONTYS is contraindicated in patients with uncontrolled hypertension. Appropriately control hypertension prior to initiation of and during treatment with OMONTYS. Reduce or withhold OMONTYS if blood pressure becomes difficult to control. Advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions.
For lack or loss of hemoglobin response to OMONTYS, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for antibodies to peginesatide.
Patients receiving OMONTYS may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Evaluate transferrin saturation and serum ferritin prior to and during OMONTYS treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
The most common adverse reactions in clinical studies in patients with CKD on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea, cough, and arteriovenous fistula site complication.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California. Affymax’s mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses. The company’s first marketed product, OMONTYS, was approved by the U.S. Food and Drug Administration (FDA) in March 2012. For additional information on Affymax, please visit .
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit .
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