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Biotech / Medical : Biotech Valuation

CRSP 51.11

-2.1%

Nov 13 3:59 PM EST

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To: Biomaven who started this subject	6/29/2001 10:09:50 AM
From: Mark Bong	Read Replies (2) of 52153

Another FDA slowdown for a major drug Hopefully higher FDA staffing levels and new leadership will move things along faster in the not too distant future. MB Friday June 29, 9:54 am Eastern Time Approval for Amgen's Aranesp delayed by regulators (UPDATE: Reledes; adds share price in 3rd paragraph) NEW YORK, June 29 (Reuters) - Amgen Inc. (NasdaqNM:AMGN - news), the world's biggest biotechnology company, said on Friday that U.S. regulators were taking longer than expected to approve its anti-anemia drug Aranesp. Thousand Oaks, California-based Amgen said it was still in discussions with the U.S. Food and Drug Administration over how to label the drug. The company is hoping Aranesp will succeed Epogen, its existing anti-anemia drug. Epogen had sales of about $503 million in the first quarter. Amgen's shares fell 92 cents to $61.74 Friday on Nasdaq. Amgen submitted Aranesp for approval to the FDA for the treatment of anemia associated with chronic kidney disease. The drug has already been approved for sale by the European Union and Australia. The company said it was encouraged by its discussions with the FDA, adding that the FDA has not asked for additional data. biz.yahoo.com

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