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|New Data Highlight Aranesp Efficacy in Anemic Patients with Lymphoid Cancer|
LYON, FRANCE, June 16, 2003 - Amgen (Nasdaq:AMGN), the world's largest biotechnology company, presented data showing that three times as many anemic patients with lymphoid cancers receiving Aranesp® (darbepoetin alfa) experienced increases in hemoglobin levels compared to those receiving placebo. These data support the recent recommendation by the European Committee on Proprietary Medicinal Products (CPMP) to extend the Aranesp® label to include treatment of chemotherapy-induced anemia in adult patients with non-myeloid malignancies. Results from the study were presented at the European Hematology Association meeting by Michael Hedenus, MD, of Sundsvall Hospital, Sundsvall, Sweden.
"Our study addressed the question of whether myelomas responded better than lymphomas to treatment with erythropoietic proteins. We found that Aranesp® was equally efficacious in patients with myeloma and lymphoma," said Dr. Hedenus. "Given the prevalence of anemia among chemotherapy patients, these data provide important insight into how doctors can best manage this serious and debilitating condition."
In the multi-center double-blind trial, 349 adults with lymphoid system cancers and hemoglobin levels ≤11.0g/dL were randomized to receive Aranesp® or placebo for
12 weeks. Dr. Hedenus reported that, overall, 60 percent of patients receiving Aranesp® achieved an increase in hemoglobin of ≥2.0 g/dL from baseline, compared to only 18 percent in the placebo group, (p<0.001). Patients receiving Aranesp® also experienced higher mean changes in hemoglobin compared to placebo. Participants who received red blood cell transfusion in the preceding 28 days were not included in the analysis.
"In addition to effectively correcting anemia, we also noted that patients receiving Aranesp® experienced clinically significant improvements in fatigue," said Dr. Hedenus.
The most frequently reported adverse events were consistent with those previously observed with darbepoetin alfa in this patient population (i.e., gastrointestinal and constitutional symptoms associated with chemotherapy).
Cancers of the lymphoid system (sometimes called lymphoproliferative diseases) include Hodgkin's disease, non-Hodgkin's lymphomas, chronic lymphocytic leukemia and multiple myeloma. Anemia induced by chemotherapy is particularly prevalent in these cancers, with up to 80 percent of patients developing it in the course of their disease. (Birgegard)
CPMP Recommends Extending the Aranesp® Label
Aranesp® is currently licensed in Europe for once-weekly treatment of chemotherapy-induced anemia in adults with solid tumors. Recently, the CPMP recommended extending this label to include treatment of chemotherapy-induced anemia in adult patients with non-myeloid malignancies. This encompasses solid and lymphoid cancers but excludes rare myeloid leukemia-related conditions. The new data suggest that chemotherapy-induced anemia could now be effectively treated with once weekly therapy in approximately 93 percent of all cancers. (Bray, et al)
"When this recommendation is approved by the European Commission, Aranesp® will be the only once weekly erythropoietic agent indicated for chemotherapy-induced anemia in such a wide range of cancers, irrespective of chemotherapy regimen," said Keith Leonard, vice president and general manager, Amgen (Europe) AG.
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 2-week period have been associated with serious side effects. The most commonly reported side effects in Aranesp® 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, 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.
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Note: Copies of the study abstracts are available upon request. Full prescribing information is available on the Web for Aranesp® at www.aranesp.com.