Affymax and Takeda Announce OMONTYS®Data Presentations at the American Society of Nephrology Kidney Week 2012
PALO ALTO, Calif., & DEERFIELD, Ill.--(BUSINESS WIRE)-- Affymax, Inc. (NAS: 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.
Friday, November 2, 2012:
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.
Saturday, November 3, 2012:
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.
*Note: All times are listed in Pacific Time
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.
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.
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
Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer: 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.
Hypertension: 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.
Lack or loss of response to Omontys: 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.
Dialysis management: Patients receiving Omontys may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis.
Laboratory monitoring: 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.
About Affymax, Inc.
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 www.affymax.com.
Affymax Forward-Looking Statements
This release contains forward-looking statements, including statements regarding the potential of Omontys, the continuation and success of Affymax's collaboration with Takeda and the commercialization of Omontys. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the factors affecting the commercial potential of Omontys, the continued safety and efficacy of Omontys, industry and competitive environment, regulatory requirements by the FDA or other regulatory authorities, including post-marketing studies, trials and Risk Evaluation and Mitigation Strategy, the potential for disruptions to supply, financing requirements and our ability to access capital and other matters that are described in Affymax's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.
About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc.
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 disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.
Takeda Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.
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.
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