HOUSTON, Dec. 15, 2006 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced that the Australian Drug Evaluation Committee (ADEC) of the Therapeutic Goods Administration (TGA) issued a positive opinion recommending the approval of THELIN(tm) (sitaxentan1 sodium) 100 mg tablets as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).
The TGA will now consider the ADEC's positive opinion in making its decision regarding marketing approval for THELIN(tm).
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.
1 "Sitaxentan" sodium is the spelling recognized by the World Health Organization for Encysive Pharmaceuticals' sitaxsentan sodium.
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This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are decisions by regulatory authorities regarding whether and when to approve our drug applications for THELIN(tm) (sitaxsentan sodium),and their decisions regarding labeling and other matters that could affect the availability and commercial potential of THELIN, and the speed with which regulatory authorizations and approvals could be achieved, as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.