HOUSTON, May 25 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced the submission of a complete response to the concerns and observations as noted in the March 24 approvable letter issued by the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Thelin(TM) (sitaxsentan sodium) 100 mg. The FDA is currently evaluating Thelin as a potential new oral treatment for pulmonary arterial hypertension.
"Encysive and the FDA have come to the mutual agreement that the Company's approach to responding to the items outlined in the approvable letter with our existing data set is reasonable, making possible the submission of a complete response," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "We look forward to continuing our productive relationship with the Agency."
The Company expects to hear within 30 days whether the FDA accepts the submission for review.
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 .
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 the U.S. Food and Drug Administration and other regulatory authorities regarding whether and when to approve our drug applications for Thelin(TM) (sitaxsentan sodium), 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.
Encysive Pharmaceuticals Inc.CONTACT: investors, Ann Tanabe, VP, Investor Relations and CorporateCommunications of Encysive Pharmaceuticals Inc., +1-713-796-8822; or MarcyStrickler of The Trout Group, +1-212-477-9007, ext. 27, or media, BradMiles of BMC Communications, +1-212-477-9007, ext. 17; both for EncysivePharmaceuticals Inc.
Web site: http://www.encysive.com/
