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[DewDiligence]

FDA Issues Third Approvable Letter for ENCY’s Thelin

[More clinical studies are needed to satisfy the FDA. With GILD’s approval today, this is quite a serious double whammy for ENCY. CC Monday at 8am ET.]

http://biz.yahoo.com/pz/070615/121488.html

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Friday June 15, 7:31 pm ET

HOUSTON, June 15, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (NasdaqGM: ENCY ) today announced that the Company has received its third 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).

In this third approvable letter, the FDA stated that Encysive's development program for THELIN did not demonstrate the evidence of effectiveness needed for approval. The FDA did note, however, that the THELIN development program provides some evidence that THELIN improves exercise tolerance in PAH. The FDA encouraged the Company to conduct an additional study to demonstrate the drug's effectiveness in exercise capacity as measured by change in six-minute walk distance.

``We believe we adequately addressed the issue raised by the FDA in the second approvable letter and we are deeply disappointed in their decision. Encysive remains committed to THELIN in Europe, Australia and Canada, where it has been approved for sale,' commented Bruce Given, M.D., President and CEO of Encysive Pharmaceuticals Inc. ``We greatly appreciate the PAH patients and clinicians in the U.S. and worldwide who have been so supportive of the THELIN development program,' he added.

Encysive plans to discuss the most recent approvable letter with the FDA as soon as possible to determine the appropriate path forward.

The Company may be required to make significant reductions in its infrastructure and workforce in the U.S. as a result of the decision by FDA. The Company is reviewing its strategic alternatives and intends to communicate its plans at a later date.

Conference Call Information

Encysive will host a conference call on Monday, June 18, 2007, at 8:00 a.m. ET, to discuss the FDA approval of THELIN. 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: [phone]
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 July 18, 2007. Additionally, a replay of the call will be available until Friday, June 22, 2007 at 11:59 p.m. ET. The call replay can be accessed by calling:

Number: [phone]
Access Code: 877197
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