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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Gordon James who wrote (270)	8/30/1999 10:46:00 AM
From: RCMac	Read Replies (1) of 666

FDA requires modifications to CLTR's Bexxar application: Monday August 30, 7:50 am Eastern Time Company Press Release biz.yahoo.com Coulter Pharmaceutical and SmithKline Beecham Announce FDA Notification On License Application for Bexxar SOUTH SAN FRANCISCO, Calif. and PHILADELPHIA, Penn.--(BW HealthWire)--August 30, 1999--Coulter Pharmaceutical, Inc. (Nasdaq:CLTR - news) and SmithKline Beecham (NYSE:SBH - news) today announced that the U.S. Food and Drug Administration (FDA) has requested modifications to the Biologics License Application (BLA) for Bexxar(TM) (tositumomab, iodine I 131 tositumomab) submitted for marketing approval for the treatment of relapsed or refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphoma. In written communication to Coulter, the FDA's requests principally involved reformatting of certain sections and additional analyses of existing data in the BLA. No additional trials were requested nor did the FDA require new information from ongoing trials or on manufacturing. ''We believe that we can respond quickly to these requests and will work closely with our partners and the FDA towards an expeditious acceptance of our application,'' said Michael F. Bigham, president and chief executive officer of Coulter. ''Our goal is to make Bexxar commercially available as soon as possible to the patients suffering from this life-threatening disease.'' Kevin Lokay, vice president, Oncology at SmithKline Beecham Pharmaceuticals said, ''We remain confident in the Bexxar BLA submission and maintain our optimism about the potential for this exciting new product.'' (snip)

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