THOUSAND OAKS, Calif. August 23, 2002 -- Amgen (Nasdaq:AMGN) today announced it has filed a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for the ENBREL (etanercept) manufacturing facility in Rhode Island, and for the related fill-and-finish operations.
"This is an important milestone, on track with our previous expectations," said Fabrizio Bonanni, Amgen's Senior Vice President for Quality and Compliance. "We have been working closely with the FDA and our contract manufacturers to meet our goal of achieving a timely approval of the Rhode Island facility so that we can, in turn, increase the supply of ENBREL for patients in the future."
Amgen and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), market ENBREL in North America.
Additional information about ENBREL, including full Prescribing Information, can be found on the Web site sponsored by the companies at www.enbrel.com or by calling toll free 888-4ENBREL (888-436-2735).
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 August 23, 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.
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Contact: Amgen, Thousand Oaks
Rebecca Hamm, 805/447-3872 (media)
Cary Rosansky, 805/447-4634 (investors)
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