THOUSAND OAKS, Calif., - December 24, 2002 - Amgen Inc. (Nasdaq: AMGN), today announced that the United States District Court for the District of Columbia dismissed Amgen's recently filed complaint against the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS).
The case was dismissed based upon the court's determination that Amgen lacked standing to challenge CMS from implementing certain provisions relating to Aranesp® (darbepoetin alfa) included in the new rule that contains changes to the Medicare hospital outpatient prospective payment system. Amgen is disputing the legality of the provisions that will result in a significantly lower reimbursement rate than the current rate for Aranesp® provided to Medicare patients in the hospital outpatient setting, effective January 1, 2003. As the court has not yet issued its written opinion, Amgen will explore all of its options in connection with this ruling. Amgen will also continue to work vigorously in all appropriate forums to correct inaccuracies in the rule.
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 December 24, 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
Jeff Richardson, 805/447-3227 (media)
Cary Rosansky, 805/447-4634 (investors)
EDITOR'S NOTES: An electronic version of this news release may be accessed via our web site at http://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.