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Randomized Head-to-Head Trial Shows Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once a Week in Breast Cancer Patients
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Dec. 11, 2004--Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that data from a head-to-head study show that 200 mcg of Aranesp(R) (darbepoetin alfa) dosed once every two weeks has similar efficacy to 40,000 U of Epoetin alfa dosed once every week in boosting hemoglobin and reducing the need for blood transfusions in breast cancer patients with chemotherapy-induced anemia. The results were presented by one of the study's lead investigators, Lee Schwartzberg, M.D., FACP, medical director of The West Clinic, Memphis, Tenn., at the 27th annual San Antonio Breast Cancer Symposium (SABCS). (SABCS Abstract #6030)
"In this trial, no differences in the ability to achieve, in the time to achieve or in the ability to maintain the target hemoglobin range were observed between the two treatment groups," said Dr. Schwartzberg. "These findings are important as they suggest that Aranesp is effective in correcting anemia when administered every two weeks, which is potentially more convenient than every week administration for patients and caregivers."
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 (ASH)/American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines for cancer and treatment-related anemia). In the multi-center trial, 141 breast cancer patients were randomized to receive either 200 mcg of Aranesp dosed every two weeks (n=72) or 40,000 U of Epoetin alfa dosed once a week (n=69).
More than 90 percent of patients in both groups achieved hemoglobin levels of greater than or equal to 11 g/dL (93 percent in Aranesp group and 90 percent in Epoetin alfa group). The median time to reach the target hemoglobin level was three weeks in the Aranesp group and four weeks in the Epoetin alfa group. After achieving the target hemoglobin level, 93 percent of patients in the Aranesp group remained in the target hemoglobin range compared to 91 percent in the Epoetin alfa group.
During the study, a lower proportion of patients treated with Aranesp (six percent) required a blood transfusion compared with patients treated with Epoetin alfa (16 percent). At the beginning of the trial, mean baseline hemoglobin was 10.5 g/dL for the Aranesp group and 10.6 g/dL for the Epoetin alfa group. At the end of treatment, mean change in hemoglobin was 1.9 g/dL for Aranesp and 1.7 g/dL for Epoetin alfa.
Both Aranesp and Epoetin alfa had similar safety profiles in this study. During the treatment period, 15 percent of Aranesp patients and 24 percent of Epoetin alfa patients had one or more serious adverse events. These events were consistent with those observed in cancer patients receiving chemotherapy and included general disorders, administration site conditions and gastrointestinal disorders. No thrombotic events occurred.
In July 2002, Aranesp was approved by the U.S. Food and Drug Administration (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.
Forward Looking Statement
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 on to 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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SOURCE: Amgen Inc.