Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA), today announced that multiple abstracts on OMONTYS ® (peginesatide) Injection have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2012 taking place October 30 – November 4, 2012 in San Diego, Calif. ASN will feature eight OMONTYS presentations (one oral session; seven poster sessions), six of which include data from the Phase 3 clinical program. Three other posters accepted for presentation highlight findings from observational studies on anemia management. Details of the presentations at ASN Kidney Week 2012 follow: Thursday, November 1, 2012
- Intravenous (IV) Iron Use in U.S. Hemodialysis Patients Receiving Peginesatide for Anemia Due to Chronic Kidney Disease (Provenzano, et al.)Oral Program # TH-OR097: 4:30 p.m.-6:30p.m.
- Candidate Action Mechanisms of Peginesatide-Induced Erythropoiesis (Verma, et al.)Poster Board # TH-PO180: 10 a.m.-12 p.m.
- Efficacy of Peginesatide Versus Epoetin by Baseline Characteristics in Hemodialysis Patients with Anemia Due to Chronic Kidney Disease (CKD) (Levin, et al.)Poster Board # TH-PO823: 10 a.m. -12 p.m.
- Initial Dose Stability After Conversion to Peginesatide in Hemodialysis Patients (Schiller, et al.)Poster Board # FR-PO261: 10 a.m.-12 p.m.
- Peginesatide Immunogenicity in Clinical Studies of Chronic Kidney Disease Patients (Schatz, et al.)Poster Board # FR-PO262: 10 a.m.-12 p.m.
- Hemoglobin Control and Dose Alterations with Peginesatide Versus Epoetin for Hemodialysis Patients (Spinowitz, et al.)Poster Board # FR-PO260: 10 a.m.-12 p.m.
- Pharmacokinetics: Pharmacodynamics of Peginesatide in Patients with Chronic Kidney Disease on Dialysis (Czerniak, et al.)Poster Board # FR-PO837: 10 a.m.-12 p.m.
- Missed Dialysis Sessions Result in Increased Erythropoiesis-Stimulating Agent Use (Bonds, et al.)Poster Board # FR-PO236: 10 a.m.-12 p.m.
- Persistent Increases in ESA Utilization Following Hospitalization of End-Stage Renal Disease Patients (Bonds, et al.)Poster Board # FR-PO237: 10 a.m.-12 p.m.
- Relationship Between Baseline Inflammatory Status and Cardiovascular Events in Hemodialysis Patients on Peginesatide or Epoetin (Locatelli, et al.)Poster Board # SA-PO629: 10 a.m.-12 p.m.
- Impact of Frequent Hemoglobin Measurement and Erythropoiesis-Stimulating Agent Dose Titration on Hemoglobin Stability in Dialysis (Szczech, et al.)Poster Board # SA-PO643: 10 a.m.-12 p.m.
OMONTYS is approved 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 additional Important Safety Information including Boxed WARNINGS below.About OMONTYS OMONTYS ® (peginesatide) Injection is a synthetic, pegylated, peptide-based ESA, and its building blocks (amino acids) are arranged in a different order than erythropoietin (i.e., it has no sequence homology to endogenous erythropoietin). 1,2 On March 27, 2012, the FDA approved OMONTYS (dosed once-monthly) for the treatment of anemia due to CKD in adult patients on dialysis. 1 About Anemia Due to CKD in Adult Patients on Dialysis Anemia is a complication of CKD and is associated with cardiovascular illness and mortality. 1 As of 2010, the United States Renal Data System noted there were more than 410,000 people in the United States who were on dialysis. 2
|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.|
Warnings and PrecautionsIncreased 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
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections. 1 Foley RN, Parfrey PS, Harnett JD. The impact of anemia on cardiomyopathy, morbidity, and mortality in end-stage renal disease. Am J of Kidney Dis. 1996;28: 58-59. 2 United States Renal Data System. United States Renal Data System 2012 annual data report: Atlas of end-stage renal disease. http://www.usrds.org/atlas.aspx. Accessed September 27, 2012. Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50443787&lang=en