UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 12, 2004
(November 11, 2004)
ENCYSIVE PHARMACEUTICALS INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 0-20117 13-3532643
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
6700 WEST LOOP, 4TH FLOOR, BELLAIRE, TEXAS 77401
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 713-796-8822
Not Applicable
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(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
[ ] Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
ITEM 8.01 OTHER EVENTS.
Encysive Pharmaceuticals Inc. announced that the U.S. Food and Drug
Administration (FDA) has granted orphan drug designation to
Thelin(TM)(sitaxsentan sodium).
The U.S. Orphan Drug Act of 1983 provides incentives for companies
that are developing and marketing therapies for diseases and disorders that
affect fewer than 200,000 people in the United States. Following FDA approval,
the Orphan Drug Act provides a drug market exclusivity for a particular
indication for a period of seven years. Additionally, orphan drug designation
provides protocol assistance, clinical trial support, tax credits, grant
funding for research, and waiver of the Prescription Drug User Fee Act (PDUFA)
filing fee. The full text of the press release is furnished herewith as Exhibit
99.1 and is incorporated herein by reference.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
99.1 Press Release.
[SIGNATURE PAGE FOLLOWS]
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ENCYSIVE PHARMACEUTICALS INC.
(Registrant)
Date: November 11, 2004
/s/ Stephen L. Mueller
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Stephen L. Mueller
Vice President, Finance and Administration
Secretary and Treasurer
EXHIBIT INDEX
EXHIBIT NUMBER DESCRIPTION
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99.1 Press Release.