Encysive Pharmaceuticals (ENCY)

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Encysive Pharmaceuticals Provides Update for Thelin (Sitaxsentan Sodium)

HOUSTON, July 13, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that the Company and officials from the U.S. Food and Drug Administration (FDA) held a formal Class A preliminary dispute resolution meeting regarding the June 15th approvable letter and the status of our New Drug Application (NDA) for Thelin(tm) (sitaxsentan sodium). Several members of Encysive's internal and external regulatory team attended the meeting with the FDA. In addition, Robyn J. Barst, M.D., Professor of Pediatrics at Columbia University College of Physicians and Surgeons, and Director, New York Presbyterian Hospital Pulmonary Hypertension Center and a principal investigator in the STRIDE-2 trial, attended the meeting.
The Company originally submitted an NDA for Thelin to treat pulmonary arterial hypertension (PAH) in February 2005. In the June 15th approvable letter, the FDA concluded that Encysive's clinical development program for Thelin did not demonstrate significant evidence of efficacy needed for approval.
This meeting complies with the FDA's guidance on dispute resolution requiring that a sponsor meet with the division reviewing its NDA prior to requesting formal dispute resolution. The Company expects to file a request for formal dispute resolution with the FDA in the near term.