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The United States Pharmacopeia Accepts Amgen's Aranesp for Treatment of Chemotherapy-Associated AnemiaTHOUSAND OAKS, Calif., Feb 4, 2002 -- Amgen (Nasdaq:AMGN) today announced that the United States Pharmacopeia (USP), an independent source for labeled and unlabeled drug information, has reviewed published clinical data on Aranesp(TM) (darbepoetin alfa) and accepted it for the treatment of chemotherapy-associated anemia and anemia associated with chronic renal failure.
The USP promotes the public health by establishing and disseminating officially recognized standards of quality and authoritative information for the use of medicines and other health care technologies by health professionals, patients and consumers. USP expert committees routinely evaluate information on the use of drugs. The use of Aranesp(TM) for the treatment of chemotherapy-associated anemia and for anemia associated with chronic renal failure has been classified by the USP as "Accepted," or, supported by evidence and current medical practice. The USP will accept comments on the proposed monograph for the treatment of chemotherapy-associated anemia through March 4, 2002.
In the third quarter of 2001, Amgen submitted to the U.S. Food & Drug Administration (FDA) a Biologics License Application Supplement for Aranesp(TM) for the treatment of cancer patients suffering from anemia associated with certain types of chemotherapy. The company is awaiting FDA action. In September of 2001, the FDA approved Aranesp(TM) for the treatment of anemia associated with chronic renal failure including patients on and not on dialysis.
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 payers, 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 Amgen routinely obtains patents for our products and technology, the protection offered by Amgen 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 February 4, 2002 and does not plan to update this information until its next press release and expressly disclaims any duty to update information contained in this press release.
Amgen is a global biotechnology company that discovers, develops and manufactures important human therapeutics based on advances in cellular and molecular biology.
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CONTACT: Amgen, Thousand Oaks
Jeff Richardson, 805/447-3227 (media)
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