THOUSAND OAKS, Calif., - November 15, 2002 - Amgen Inc. (NASDAQ:AMGN) today announced that it has filed a complaint in the United States District Court for the District of Columbia against the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS).
The complaint seeks an injunction prohibiting CMS from implementing certain provisions of the recently announced new rule that contains changes to the hospital outpatient prospective payment system. Specifically, Amgen is disputing the legality of provisions that would result in a significant reduction in the reimbursement rate for Aranesp® (darbepoetin alfa) for Medicare patients in the hospital outpatient setting, effective January 1, 2003. Aranesp, a unique and innovative biologic, is the latest advance in anemia management requiring less frequent dosing than the previous standard of care.
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 November 15, 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.
Contact: Amgen, Thousand Oaks
Barbara Bronson Gray, 805/447-4949 (media)
Cary Rosansky, 805/447-4634 (investors)
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