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Biotech / Medical : Texas Biotech (TXB)

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To: keokalani'nui who wrote (820)	8/20/2001 4:20:33 PM
From: keokalani'nui	Read Replies (1) of 834

Argatroban Competitor Schering seeking Refludan rights from Aventis Last Updated: 2001-08-17 16:20:51 EDT (Reuters Health) By Doug Macron NEW YORK (Reuters Health) - Schering AG is seeking to acquire from France's Aventis SA certain rights to the heparin-induced thrombocytopenia (HIT) treatment Refludan (lepirudan (rDNA) for injection), a spokeswoman for the German drug firm confirmed in an interview with Reuters Health on Friday. Refludan is a direct thrombin inhibitor currently approved in the US and 31 other countries for HIT. In May of last year, an application seeking approval of the drug for use in adults suffering from acute coronary syndrome was rejected by US regulators. The Schering spokeswoman declined to comment on specifics of any possible deal, but said that additional details would be released by the company on Monday. According to a US Federal Trade Commission (FTC) notice, Aventis SA has petitioned the agency to approve the divestiture of "Refludan assets" to Schering. The sale would fulfill one of the FTC's requirements spelled out under a 1999 antitrust settlement between Hoechst and Rhone-Poulenc, which merged to become Aventis. Prior to the merger, US and European regulators expressed concerns that the new company would hold an unfairly advantageous position in the direct thrombin inhibitor (DTI) market. Hoechst was already selling Refludan, and Rhone-Poulenc was in the final stages of developing another DTI called Revasc. Pursuant to the terms of the antitrust settlement, Aventis would have to divest the North American rights to Refludan. The Schering spokeswoman would not comment on what Refludan rights the company was seeking. Representatives from Aventis were not immediately available for comment. ________________________________ [From txb 10K: Refludan(R) (lepirudin, Aventis). This product received approval in Europe in 1997 and in the U.S. in 1998 for anticoagulation in patients with HITTS to prevent further thromboembolic (clotting) complications. Refludan(R) has been associated with the development of an adverse immune response in up to 40% of patients receiving that drug. Although the full clinical impact of development of these antibodies is unknown, we understand that the anticoagulant effects of Refludan(R) may become unpredictable in patients developing these antibodies. Based on certain information from clinical trials, we also believe Argatroban has a significantly better safety profile than Refludan(R).]

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