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Published Head-to-Head Data Show Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once-a-Week
Data Show Aranesp(R) Offers Patients Added Convenience and Flexibility in the Treatment of Anemia
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Nov. 24, 2004-- Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced that data published online in the December edition of The Oncologist from a study analyzing three identical head-to-head trials show that 200 mcg of Aranesp(R) (darbepoetin alfa) dosed once every two weeks is as effective as 40,000 U of Epoetin alfa dosed once-a-week in boosting hemoglobin and reducing the need for blood transfusions in cancer patients with chemotherapy-induced anemia.
"In treating patients suffering from chemotherapy-induced anemia, physicians should try to accommodate patient convenience without compromising the effectiveness of care," said the study's lead investigator, Lee Schwartzberg, M.D., FACP, medical director of The West Clinic, Memphis, Tenn. "The full publication of these results is important as the data show that Aranesp effectively treats anemia with half the injections and office visits required with Epoetin alfa."
The analysis includes data on 312 patients from three studies with breast, non-small cell lung cancer (NSCLC) or gynecological cancer who were randomized to receive either Aranesp 200 mcg every two weeks or Epoetin alfa 40,000 U once-a-week. Patients in both groups achieved target hemoglobin of greater than or equal to 11 g/dL and had similar blood transfusion rates.
The results were analyzed based upon the achievement and maintenance of target hemoglobin threshold (greater than or equal to 11 g/dL) and range (11-13 g/dL, which is based on the American Society of Hematology/American Society of Clinical Oncology (ASH/ASCO) and National Comprehensive Cancer Network (NCCN) guidelines for cancer and treatment-related anemia). More than 80 percent of patients in both arms of the study achieved target hemoglobin levels. Transfusions were similar in the two treatment groups, at 16 percent for the Aranesp group and 17 percent for the Epoetin alfa group. After achievement of a hemoglobin level of greater than 11 g/dL, the mean hemoglobin level was maintained at approximately 12 g/dL for the remainder of the trials in both treatment groups. Eighty-one percent of patients in the Aranesp group remained in the target range compared to 75 percent in the Epoetin alfa group.
The study's primary endpoint was validation of the Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-An), which assessed the impact of receiving anemia treatment. Results from the patient satisfaction questionnaire given to study participants demonstrate that medical visits for anemia treatment incur a burden on patients and caregivers. Patients spend on average two hours traveling to and from their oncologist's office and two hours at the office receiving treatment. In addition, the survey shows that the majority of patients would have preferred to spend time with family and friends.
The number and type of adverse events were similar between the two treatment groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving chemotherapy and study drug. Three treatment-related serious adverse events were reported, one episode in each treatment group of deep venous thrombosis and one episode of pulmonary embolism in the Epoetin alfa group.
In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the discovery of recombinant erythropoietin, Epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R)(1) and by Ortho Biotech Products, LP, as Procrit(R)(2). Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule, resulting in more activity, with the added benefit of less-frequent administration (for example, where Epoetin alfa is administered three times a week, Aranesp should be administered weekly).
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
The Aranesp dosage should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL. Doses must be individualized to ensure that hemoglobin is maintained at an appropriate level for each patient.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging onto www.aranesp.com.
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(1) EPOGEN(R) is a registered trademark of Amgen Inc.
(2) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.
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