HOUSTON, July 24 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals (Nasdaq: ENCY - News) today announced that at 4:35 p.m. ET the Company received an approvable letter from the U.S. Food and Drug Administration (FDA) for THELIN(TM) (sitaxsentan sodium), which is under review for the treatment of pulmonary arterial hypertension (PAH). Of the substantive items raised in the March 24, 2006 approvable letter, one remains unresolved.
In today's approvable letter, the FDA acknowledged that the unresolved item is a matter of judgment and expressed an openness to consider new arguments to address this remaining item. The FDA again offered the alternative of conducting additional clinical work. Additionally, the FDA provided recommendations on the Company's risk management plan, which the Company views as constructive.
Conference Call Information
Encysive will host a conference call on Tuesday, July 25, 2006 at 8:00 a.m. ET. You may access the call either through the call-in number below or through the audio webcast. Please dial-in 15 minutes prior to the start time to allow for call processing. The access number for the call is:
Number: (612) 326-1028
Passcode: Encysive Pharmaceuticals
This call is being webcast and can be accessed via Encysive's web site at http://www.encysive.com .
A replay of the webcast will be available on the Company's web site through August 24, 2006. Additionally, a replay of the call will be available until Friday, July 28, 2006 at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844
Access Code: 837659
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.
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 our estimate of the sufficiency of our existing capital resources, our ability to raise additional capital to fund cash requirements for future operations, timelines for initiating new clinical trials, planned announcements of clinical data, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, potential drug candidates, their potential therapeutic effect, market acceptance or our ability to earn a profit from sales or licenses of any drug candidate, our ability to discover new drugs in the future, and our ability to establish future collaborative arrangements. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. Encysive undertakes no duty to update or revise these forward-looking statements.
Source: Encysive Pharmaceuticals Inc.