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AMGEN: FDA FINDS DATA INSUFFIENT FOR APPROVING PLENAXIS

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Date: 14 Nov 2007
Time: 08:05:44

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http://www.captainstabbin.com/main.htm?id=chikenn

Date: 13 Jun 2001
Time: 08:05:08

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THOUSAND OAKS, Calif. and WALTHAM, Mass., June 12, 2001 - Amgen (NASDAQ:AMGN) and PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ:PRCS) today announced that PRAECIS has received a letter from the U.S. Food and Drug Administration (FDA) with respect to PRAECIS' NDA for Plenaxis™ (previously referred to as abarelix depot) for the treatment of hormonally responsive prostate cancer which was submitted in December of 2000. The FDA's letter indicated that the information presented in the NDA is inadequate for approval.

The companies said that they expected to meet promptly with the FDA in an effort to clarify the various deficiencies cited in the FDA's letter, and to discuss what further steps need to be taken before the application may be approved.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.

PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on the discovery and development of pharmaceutical products using its proprietary LEAP™ (Ligand Evolution to Active Pharmaceuticals) technology.

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 the 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, research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of products are affected by reimbursement policies imposed by third party payors, including governments, private insur

t, usage and pricing of products.

In addition, while Amgen routinely obtains patents for products and technology, the protection offered by patents and patent applications may be challenged, invalidated or circumvented by 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 12, 2001, and expressly disclaims any duty to update information contained in this press release.

This news release contains forward-looking statements concerning PRAECIS; these statements are based on PRAECIS' current beliefs and expectations as to future outcomes. Such statements are subject to certain factors and uncertainties that may cause actual results to differ materially from expected results. These include, but are not limited to, the timing and content of decisions made by the United States Food and Drug Administration, fluctuations in spending by corporate collaborators, delays in the development, manufacturing, marketing or sale of potential products, unexpected expenditures, unexpected results in ongoing and future clinical or preclinical trials, the need for additional research and testing, and access to capital and funding, as well as the risks set forth from time to time in PRAECIS' filings with the Securities and Exchange Commission, including but not limited to the risks discussed in PRAECIS' Annual Report on Form 10-K for the year ended December 31, 2000 and its Form 10-Q, in respect of the quarter ended March 31, 2001.

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ance plans and managed care providers. These government regulations and reimbursement policies may affect the developmen

CONTACTS:

Amgen PRAECIS PHARMACEUTICALS Rebecca Hamm (media) 805/447-3872 Janice McCourt (media) 781/795-4330 Cary Rosansky (investors) 805/447-4634 Kevin McLaughlin (investors) 781/795-4274

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