PHILADELPHIA, PA, December 9, 2002 - Amgen (Nasdaq: AMGN), the world's largest biotechnology company, today announced results from a study presented at the American Society of Hematology (ASH) in which Aranesp® (darbepoetin alfa) was shown to be 13 percent less expensive than Epoetin alfa while demonstrating comparable response rates for the treatment of anemia in chemotherapy patients, based on the average wholesale pricesi (AWPs) of Aranesp and Epoetin alfa over a 20-week period.
Epoetin alfa is currently marketed by Amgen as EPOGEN®ii and by Ortho Biotech Products, LP, as Procrit®iii.
The study results compared Aranesp doses of 3.0 mcg/kg every two weeks and Epoetin alfa doses of 40,000 units weekly in cancer patients suffering from chemotherapy-induced anemia. Hemoglobin response rates (percentage of patients with a hemoglobin increase of >2 g/dL from baseline, in the absence of red blood cell transfusion) were 60 percent at week 12 for both regimens.
"This study suggests that using darbepoetin alfa at this dose may provide a more cost-effective alternative to Epoetin alfa at the current weekly dose to treat anemia in many chemotherapy patients in the United States," said John A. Glaspy, MD, University of California, Los Angeles, CA, the study's lead investigator. "The respective cost of the drugs, coupled with the less-frequent dosing and therefore fewer office visits for patients than Epoetin alfa, makes darbepoetin alfa a viable option for treating anemia in cancer patients receiving chemotherapy."
Aranesp maintains its level in the blood approximately three times longer than Epoetin alfa, offering healthcare providers the ability to treat anemia related to chemotherapy with less-frequent dosing. Less-frequent dosing results in fewer injections for patients. It allows patients and caregivers to spend less time scheduling injection visits, and enables physicians and nurses to attend to other patients and work activity.
The study was based on a "cost-effectiveness ratio" (cost per percentage of patients with Hgb response) which was found to be superior for Aranesp® ($16,633 for Aranesp vs. $18,812 for Epoetin alfa). [ASH Abstract # 3447; Glaspy et al.]
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 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 more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-Q. Amgen conducts research in the biotechnology/pharmaceutical field where 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.
Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products.
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Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of December 9, 2002 and expressly disclaims any duty to update information contained in this press release.
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Contact: Amgen, Thousand Oaks
Michael J. Beckerich, 805/447-8925 (media)
Cary Rosansky, 805/447-4634 (investors)
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Aranesp prescribing information can be accessed by logging onto www.Aranesp.com