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Final Results of Phase 3 Head-to-Head Study Demonstrate Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Weekly in Cancer Patients with Chemotherapy-Induced Anemia
ORLANDO, Fla.--(BUSINESS WIRE)--May 15, 2005--Amgen Inc. (NASDAQ:AMGN):
- Randomized Head-to-Head Study of Anemia Treatments Shows Comparability in Transfusion Rates and Achievement of Target Hemoglobin in More Than 1,200 Patients with Chemotherapy-Induced Anemia
Amgen Inc., (NASDAQ:AMGN) the world's largest biotechnology company, today announced that final results of a Phase 3 randomized, head-to-head study demonstrated that 200 mcg of Aranesp(R) (darbepoetin alfa) administered every two weeks is as effective as 40,000 U of Epoetin alfa dosed once a week in boosting hemoglobin levels and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). (Abstract #8125)
"This is the largest, randomized head-to-head comparison of darbepoetin alfa dosed every two weeks to Epoetin alfa dosed weekly, as they are most often used in current oncology practice," said John Glaspy, MD, professor, David Geffen School of Medicine, University of California at Los Angeles. "Less frequent dosing provides anemia management with less frequent injections, and for patients receiving chemotherapy every two or three weeks, less frequent office visits. Our data demonstrate that less frequent injections can be accomplished without a compromise in efficacy in terms of decreased transfusion risk or improved quality of life."
In the Phase 3 head-to-head study, a total of 1,220 patients with chemotherapy-induced anemia were randomized to receive either Aranesp 200 mcg every two weeks (n=613) or Epoetin alfa 40,000 U once a week (n=607). The majority of patients in both groups achieved the target hemoglobin of greater than or equal to 11 g/dL. Both groups of patients had similar blood transfusion rates, patient reported outcomes, and safety endpoints.
In this study, at least 90 percent of patients in both arms of the study achieved target hemoglobin of greater than or equal to 11 g/dL. Seventy-four percent of patients in the Aranesp group remained in the target range compared to 80 percent in the Epoetin alfa group. The study's primary endpoint was designed to evaluate non-inferiority with respect to transfusion rate. Transfusions were similar in the two treatment groups (21 percent in the Aranesp group and 16 percent in the Epoetin alfa group) demonstrating non-inferiority of Aranesp and Epoetin alfa with respect to transfusion requirements.
The number and type of adverse events were similar between the two groups and were consistent with the adverse event profile for this population of anemic cancer patients receiving Aranesp.
New interim data from a study of Aranesp administered every three weeks were also presented during the ASCO Annual Meeting (Abstract #8129). In May, Amgen announced submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs. Anemia occurs when there are too few red blood cells and the body's tissues are "starved" of oxygen, which can make a patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo chemotherapy in the United States; approximately 800,000 (67 percent) will become anemic. More than half of these patients report that fatigue associated with anemia affects their daily lives more than any other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of chemotherapy, it is often not recognized and frequently under-treated. In fact, 42 percent of patients with a hemoglobin level less than the recommended target level of 11 g/dL in the National Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the development of recombinant erythropoietin, Epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products, L.P., as Procrit(R) (Epoetin alfa)(ii). Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. By virtue of its longer half-life, Aranesp should be administered less frequently than Epoetin alfa in patients with chronic kidney disease (CKD).
Aranesp is approved for multiple indications with varying dosage instructions in the U.S., European Union, Canada and Australia. Aranesp was approved by the FDA in September 2001 for up to every-two-week dosing for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for weekly dosing for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. In 2004, the European Committee for Medicinal Products for Human Use approved Aranesp for extended dosing intervals of once every three weeks in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and monthly in the treatment of anemia associated with CKD.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events, and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any two-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12-14 g/dL, an increased incidence of thrombotic events, disease progression and mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever and dyspnea.
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, 2004, 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.
(i) Epogen(R) is a registered trademark of Amgen Inc.
(ii) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P.
Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.