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Amgen Receives CPMP Positive Recommendation For European Union Regulatory Approval Of Aranesp(R)n Oncology Thousand Oaks, Calif., USA and Lucerne, Switzerland, June 3, 2002 -- Amgen (Nasdaq:AMGN) today announced that the European Committee on Proprietary Medicinal Products (CPMP) has recommended approval of darbepoetin alfa (Aranesp/Nespo(R)) for the treatment of anaemia in adult cancer patients with solid tumours (non-haematological malignancies) receiving chemotherapy. Aranesp is a powerful new erythropoietic protein with greater in vivo activity than recombinant human erythropoietin (EPO).
Between 50 and 60 percent of patients with cancer undergoing chemotherapy may be anaemic. This debilitating condition is associated with, for example, dizziness, exhaustion, shortness of breath and difficulty in carrying out daily activities. Anaemia is under-treated with transfusions being the primary treatment, and currently only one-tenth of anaemic patients receive an erythropoietic agent in Europe.
"This approval will represent a significant step forward for the treatment of anaemia in patients with cancer. The less frequent dosing relative to current agents and the speed of response obtained with Aranesp provide convenient, well tolerated and highly effective therapy". said Professor Robert Pirker, Vienna, Austria, primary investigator of the pivotal phase 3 study.
The CPMP's recommendation for approval will be forwarded to the European Commission for ratification. Ratification usually requires three to four months. When ratified, Amgen will obtain the extension to the indications for Aranesp throughout the European Union (EU). Launch of this new indication in each EU country will vary according to each nation's pricing and reimbursement procedures.
A Biological License Application (BLA) supplement for Aranesp use in the oncology setting has also been submitted to the United States Food and Drug Administration for approval. Aranesp for anaemia associated with chronic renal failure was approved by the European Commission and the U.S. Food & Drug Administration in 2001.
"This recommendation for approval, combined with the separately announced Neulasta recommendation, will expand our commitment to dramatically improving the lives of patients with cancer. We are tremendeously excited about bringing these best in class therapeutics to oncology patients throughout Europe," said Keith Leonard, Vice President, Amgen Europe.
Aranesp(R) is a registered trademark in Europe.
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.
In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors.
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 June 3, 2002 and expressly disclaims any duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Amgen is headquartered in Thousand Oaks, CA, USA, with European headquarters in Lucerne, Switzerland.
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