To: Bill Wexler who wrote (443 ) 12/26/1997 7:20:00 PM From: Bharat H. Barai Read Replies (2) | Respond to of 834
I want to correct your impression about Novastan trial results. Novastan (chemical name; Argatroban, research of Mitsubishi chemicals, sub licensed by Texas Biotech in USA, with rights to Smith Kline Beecham now) is a synthetic compound with small molecular weight, that is a direct inhibitor of Thrombin. Heparin acts as anti coagulant by acting on Anti Thrombin III, which inhibits Thrombin and prevents coagulation. Novastan trials have been conducted for Cardio vascular applications, since Novastan has much shorter half life than Heparin. Those two trials were presented at the 1997 meeting of American College of Cardiology. One of them showed positive trend but did not show statistically significant difference (I think that is the one you are referring to in your post). The present Product Licence Application (PLA) filed with FDA is NOT for Cardio Vascular indication but for Heparin induced Thrombocytopenia (HIT). This multi center trial showed highly statistical significat dfference (This trial data were presented at International Hematology meeting in Milan, Italy in June, 1997). It is well known that 3-6% of patients treated with Heparin develop reduction in platelet count (Heparin inducedThrombocytopenia). Studies show very few, if any develop platelet reduction with Argatroban (Novastan). There is no viable Intravenous anti coagulant to replace Heparin if patient develops Heparin induced thrombocytopenia at present. Since Argatroban (Novastan) is already in use in Japan for 3 years without any problems, there is no viable alternative for HIT and the multi center trial showed very highly statisticaly significant benefit,it is my opinion that FDA will approve Novastan on fast track basis. N.B. Texas Biotech is developing two new products, for Asthma and Congestive Heart failure. Smith Kline is their partners in development of these two compounds. Novastan will have modest market but it is these two drugs under development that are POTENTIAL jackpots for TXB, if successful. B.H. Barai MD Hematologist