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Biotech / Medical : Biotech Valuation

CRSP 55.26

+1.2%

3:59 PM EST

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To: Biomaven who started this subject	12/3/2002 1:04:23 AM
From: Doc Bones	Read Replies (1) of 52153

Corixa Says Bexxar Is Back on Track [TSCM] By Adam Feuerstein Senior Writer 12/02/2002 05:23 PM EST Corixa (CRXA) said late Monday that U.S. drug regulators have returned its experimental cancer drug Bexxar to active review status after accepting new safety data. As a result, the Seattle-based biotech firm said the Food and Drug Administration should complete its review of Bexxar by May 2, 2003. The drug was already scheduled for review by an FDA advisory panel on Dec. 17. Last March, the FDA issued a complete review letter on Bexxar, rejecting approval based on the need to conduct additional studies to assess the drug's safety and efficacy. Corixa successfully appealed the FDA decision in June. Monday, the company said data resubmitted in March and October have satisfied the agency's outstanding issues and concerns outlined in its original complete review letter. Corixa is seeking Bexxar's approval as a new treatment for patients with advanced cases of non-Hodgkin's lymphoma. The drug, if approved, would compete directly against Zevalin, a similar drug marketed by Idec Pharmaceuticals (IDPH). European drugmaker GlaxoSmithKline (GSK) is co-developing Bexxar with Corixa. Corixa released the Bexxar news after Monday trading ended, but shares were up 21% to $8.35 in after-hours trading. The stock closed the regular session down 5% to $6.88. thestreet.com

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