-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SuQcsTDI1ehWKDoX1LSzeblUB2Yy5M9yu0JgrqLPhMxPQ+b/LnNxlgxHXZdVlI59 r+rPFkh9xpaEhvrHHW8LgQ== 0000950129-05-011915.txt : 20051213 0000950129-05-011915.hdr.sgml : 20051213 20051213173059 ACCESSION NUMBER: 0000950129-05-011915 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20051213 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20051213 DATE AS OF CHANGE: 20051213 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ENCYSIVE PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000887023 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133532643 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20117 FILM NUMBER: 051261891 BUSINESS ADDRESS: STREET 1: 4848 LOOP CENTRAL DRIVE STREET 2: SUITE 700 CITY: HOUSTON STATE: TX ZIP: 77081 BUSINESS PHONE: 7137968822 MAIL ADDRESS: STREET 1: 4848 LOOP CENTRAL DRIVE STREET 2: SUITE 700 CITY: HOUSTON STATE: TX ZIP: 77081 FORMER COMPANY: FORMER CONFORMED NAME: TEXAS BIOTECHNOLOGY CORP /DE/ DATE OF NAME CHANGE: 19930328 8-K 1 h31250e8vk.htm ENCYSIVE PHARMACEUTICALS INC. e8vk
 

 
 
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): December 13, 2005
Encysive Pharmaceuticals Inc.
 
(Exact name of registrant as specified in its charter)
         
Delaware   0-20117   13-3532643
 
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)
     
4848 Loop Central Drive, Suite 700, Houston, Texas   77081
(Address of principal executive offices)   (Zip Code)
Registrant’s telephone number, including area code: 713-796-8822
Not Applicable
 
(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):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 

 

Item 7.01. Regulation FD Disclosure.
     Encysive Pharmaceuticals Inc. (the “Company”) provides hereby the following update for certain of its Regulatory and Clinical programs. The Company’s lead drug candidate, Thelin™ (sitaxsentan sodium), is an endothelin receptor antagonist that has successfully completed pivotal Phase III clinical trials for the treatment of pulmonary arterial hypertension (“PAH”), and is under review by the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency. Recently, a regulatory submission for Thelin™ was accepted for review by the Therapeutic Goods Administration (“TGA”) of Australia. The Company’s Common Technical Document, filed with the TGA, seeks approval to market Thelin™ 100 mg as a once daily oral treatment for patients with PAH. The TGA has also granted Encysive priority evaluation for Thelin™.
     The Company also plans to develop Thelin™ more broadly in PAH and to explore indications beyond PAH. One such indication that the Company has been exploring was Interstitial Lung Disease (“ILD”). However, after evaluating recent data in ILD, the Company believes that currently there are no validated endpoints to use in an ILD study over a short period of time, with a small number of subjects. As such, the Company has chosen not to initiate a Phase IIb/III clinical study evaluating Thelin™ in ILD. The Company will continue to evaluate other exploratory studies in this disease area. A planned proof-of-concept study with Thelin in an unnamed chronic indication has cleared FDA review and is expected to enroll its first patient late this year or early in 2006.
     In addition to Thelin™, the Company is also developing a next generation endothelin receptor antagonist, TBC3711. TBC3711 is a more potent and selective ET(A) receptor antagonist with an improved metabolic profile, pre-clinically. The Company has elected to conduct a dose ranging study in resistant hypertension with TBC3711, rather than in PAH as previously indicated. This study has cleared FDA review and is expected to enroll its first patient late this year or early in 2006.
[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: December 13, 2005
       
 
      /s/ Stephen L. Mueller
 
       
 
      Stephen L. Mueller
 
      Vice President, Finance & Administration, Secretary & Treasurer

 

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