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|New Data Suggest Aranesp(R) Benefits Patients Suffering From Anemia of Cancer, Who Are Not Receiving Chemotherapy|
SAN DIEGO, Dec. 6 -- Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced interim data from a randomized, multi-center study that evaluates Aranesp (darbepoetin alfa), administered every two weeks in correcting anemia in cancer patients not undergoing chemotherapy, a condition known as anemia of cancer. The results were presented at the American Society of Hematology (ASH) Annual Meeting. [Abstract #1816]
The interim analysis of the study's first 150 anemic cancer patients with a current diagnoses or history of a nonmyeloid malignancy shows that after 12 weeks of Aranesp treatment, the mean change in hemoglobin was 1.9 g/dL for the Aranesp group and 0.2 g/dL in the control group, which received standard care. The baseline hemoglobin was 10.1 and 10.4 g/dL for the Aranesp and control groups, respectively. Patients were randomized to receive either 3 mcg/kg every other week for 21 weeks or to a control group in which there was a 12-week observation period followed by nine weeks of Aranesp. The Kaplan-Meier estimate (95 percent) of hematopoietic response was 81 percent (71, 90) for the Aranesp group and 26 percent (8, 43) for the control group. Further studies will be conducted to confirm these findings.
While anemia, an abnormally low level of red blood cells, is recognized as a common problem in cancer patients receiving chemotherapy, other patients suffer from anemia due to the cancer itself, unrelated to chemotherapy. Approximately 475,000 cancer patients in the U.S. suffer from anemia of cancer, whose common symptoms include physical and mental fatigue.
"Oncologists are beginning to focus not only on chemotherapy-induced anemia, but anemia of cancer as well," said Dr. Veena Charu, Pacific Cancer Medical Center. "Building on the findings of previous studies, we designed this study to examine the efficacy of Aranesp in treating cancer patients with anemia not receiving chemotherapy."
These data were recently evaluated by U.S. Pharmacopea Drug Index (US-PDI) for inclusion in the monograph. They formed the basis for the acceptance of Aranesp administered every two weeks in the treatment of anemia of cancer.
Aranesp was approved by the U.S. Food and Drug Administration (FDA) in July 2002 for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp was approved by the FDA in September 2001 for the treatment of anemia associated with chronic renal failure, also known as chronic kidney disease, for patients on dialysis and patients not on dialysis.
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)(i) and by Ortho Biotech Products, LP, as Procrit(R)(ii). 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.
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; no important differences were observed between Aranesp and Epoetin alfa.
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, 2002, 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.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing its products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of Amgen's products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify side effects or manufacturing problems with its products after they are on the market. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while Amgen routinely obtain patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third party suppliers.
Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging onto www.aranesp.com .
CONTACT: Amgen, Thousand Oaks Kelly Stoddard, (805) 447-0821 (media) Cary Rosansky, (805) 447-1060 (investors) (i) EPOGEN(R) is a registered trademark of Amgen Inc. (ii) Procrit(R) is a registered trademark of Ortho Biotech Products, L.P. NOTE TO EDITORS: An electronic version of this news release may be accessed via our Web site at www.amgen.com . Visit the Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Amgen News section of the Web site.