Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : Cents and Sensibility - Kimberly and Friends' Consortium -- Ignore unavailable to you. Want to Upgrade?

To: Panita who wrote (77334)	2/22/2000 7:40:00 AM
From: lurknomore	Respond to of 108040

paging Mr. Bouf ---- looks like TXB made the grade: U.S. FDA Issues Approvable Letter to Texas Biotechnology for NOVASTAN(R) as Anticoagulant Drug for Prophylaxis or Treatment of Thrombosis in Patients with Heparin-Induced Thrombocytopenia (HIT) HIT is Believed to Afflict Over 300,000 Americans a Year. It is a Paradoxical Clotting Reaction to Heparin, the Most Widely Used Blood Thinner in the Hospital Conference Call To Be Held Today Tuesday, Feb. 22. 8:30 AM EST Call in number is: 800/230-1074 HOUSTON, Feb. 22 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB) announced today that it has received an approvable letter from the U.S. Food & Drug Administration for NOVASTAN(R) (argatroban) as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. NOVASTAN is a synthetic direct thrombin inhibitor that prevents clot formation and has been developed as anticoagulant therapy for patients who can no longer receive heparin. In clinical trials, the rapid onset of action of NOVASTAN, together with its short half-life and lack of immunogenicity, resulted in predictable anticoagulation levels as well as a safe and relatively easy drug to use. Under the agreement with SmithKline Beecham (SB) in August 1997, SB has the rights to market and co-develop NOVASTAN in the United States and Canada as anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT). David M. Stout, President North America of SB, stated, "With the positive action of the approvable letter for NOVASTAN from FDA, NOVASTAN now has the opportunity of ultimately fulfilling an unmet need and providing benefits to patients requiring this life-saving drug." Currently, preparations for the marketing and commercialization of NOVASTAN are underway. Commercial-scale manufacturing of NOVSTAN has been initiated and several medical education initiatives as well as the presentation of the NOVASTAN Phase III clinical trail results are planned for the upcoming American College of Cardiology meeting in March. TBC believes that it will take approximately 60 days to satisfy FDA requirements for securing the final approval letter for NOVASTAN. John G. Kelton, M.D., a recognized expert in the area of heparin-induced thrombocytopenia, noted, "HIT is a serious and life-threatening adverse reaction to heparin. The condition is caused by a complex immune reaction characterized by a strong tendency to clot that puts the patient at risk of major complications such as heart attack and stroke which can, in turn, lead to amputation or even death. I believe that the approval of argatroban, NOVASTAN, will increase the awareness, diagnosis and successful treatment of this condition." Dr. Kelton is Professor and Chairman of Medicine, McMaster University Faculty of Health Sciences, Ontario, Canada. According to an analysis of 34 million hospitalizations from the U.S. Health Care Financing Administration database, over 10 million patients received heparin in the U.S. annually, making heparin one of the most widely used drugs in the hospital. The literature suggests that HIT occurs in approximately 300,000 to 400,000 heparin patients in the U.S. per year although it is widely believed to be under-diagnosed. The literature also suggests that approximately 30 to 60% of cardiac surgery patients exposed to heparin will form the antibodies to heparin, which causes HIT. Dr. Bruce Lewis, Associate Professor of Medicine, Loyola University Medical Center and Chief, Section of Cardiology, Catholic Health Partners, and the principal investigator for the NOVASTAN clinical program in HIT, stated, "I have used NOVASTAN in over 140 patients and have found it to be a very effective, easy to use anticoagulant that offers a much needed alternative to heparin." Dr. Lewis is the lead author on the presentation of the Phase III clinical trial results to be presented at the Annual Meeting of the American College of Cardiology which will be held in March. Texas Biotechnology Corporation (TBC) is a biopharmaceutical company focused on the development and commercialization of small molecule drugs to treat a variety of diseases including thrombosis, chronic heart failure and asthma. In addition to NOVASTAN, the Company has two compounds in Phase II development. Sitaxsentan (TBC11251), is an endothelin receptor antagonist that is being developed as a treatment for pulmonary arterial hypertension and chronic heart failure. TBC1269 is a selectin antagonist that is currently being developed for asthma.