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Biotech / Medical : Texas Biotech (TXB) -- Ignore unavailable to you. Want to Upgrade?

To: fred woodall who wrote (669)	5/11/1998 11:07:00 AM
From: fred woodall	Read Replies (1) \| Respond to of 834

Shares of Texas Biotechnology Corp. lost more than half their value Monday after the company said it received a so-called non-approvable letter from the Food and Drug Administration for its anti-coagulant drug Novastan. Texas Biotechnology said it will request a meeting with the FDA to confirm the exact requirements for further consideration of the drug. Novastan is being developed with SmithKline Beecham PLC (SBH), which had paid $11.5 million upfront to develop the drug. The development pact had also called for SmithKline to purchase $3 million in equity and make potential milestone payments of up to $20 million on annual sales to Texas Biotechnology, a biopharmaceutical company based in Houston. In late-morning trading, shares of Texas Biotechnology (TXB) plunged $4.688, or 52%, to $4.313 on volume of 850,0000. The injectable drug was being reveiwed for management of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). Both conditions are an immune reaction to heparin, the most widely used injectable anticlotting drug. The disease can lead to widespread clotting, which can result in significant illness and death. Currently, there is no alternative in the U.S. to heparin for patients who develop HIT. A nonapprovable letter informs a company that the drug can't be approved by the FDA in its current form. Texas Biotechnology said it is confident it will be able to resolve the FDA's concerns. The company didn't say what the FDA wants from the firm before the drug can be approved for sale. Novastan would have been the company's first approved drug on the market.