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To: Jorj X Mckie who wrote (27830)2/20/2003 8:43:42 AM
From: 2MAR$  Respond to of 57110
 
BGEN sour news out , back into $35's

European Approval of AMEVIVE(R) Delayed
Thursday February 20, 8:11 am ET
Committee Requests Additional Clinical Information

CAMBRIDGE, Mass., Feb. 20 /PRNewswire-FirstCall/-- Biogen, Inc. (Nasdaq: BGEN - News) announced today that the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA), requested more information relating to its application for AMEVIVE® (alefacept) for psoriasis. In the final assessment received this week, the CPMP determined that more clinical information is needed to approve the product. Biogen has withdrawn its application and plans to develop the additional clinical information necessary to obtain approval of AMEVIVE for psoriasis patients in Europe. Developing the data and re-filing the application to gain approval could take several years.
(Photo: newscom.com )
This action should have no impact on the company's 2003 financial guidance. Biogen will be evaluating the impact on guidance for 2004 and beyond, considering the delay of European revenue as well as sales and marketing expense, and updating this outlook in its quarterly earnings call.