-----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, PZQP/pffOd1OxuHvVKxZ9s0MQVnk9m0gNwwcS2dutVE8wAiwGpE4blx8hoMtepWG 9M4j9w2RL5mB4WeYi7kz9A== 0000950129-05-007046.txt : 20050714 0000950129-05-007046.hdr.sgml : 20050714 20050714071602 ACCESSION NUMBER: 0000950129-05-007046 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050713 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050714 DATE AS OF CHANGE: 20050714 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: 05953452 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 h27014e8vk.htm ENCYSIVE PHARMACEUTICALS INC. - JULY 13, 2005 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) : July 14, 2005

Encysive Pharmaceuticals Inc.

 
(Exact name of registrant as specified in its charter)
         
Delaware   0-20117   13-3532643
 
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
4848 Loop Central Drive, Suite 700, Houston, Texas
(Address of principal executive offices)
  77081
(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 8.01 Other Events.

     On July 14, 2005, Encysive Pharmaceuticals Inc. (the “Company”) announced that the Cardio-Renal Division of the U.S. Food and Drug Administration, in correspondence with the Company, stated that it anticipates filing Encysive’s New Drug Application for ThelinÔ (sitaxsentan) on July 23, 2005, under a standard review classification. Thelin 100 mg is being evaluated as a once daily oral treatment for patients with pulmonary arterial hypertension. The FDA has simultaneously requested a plan for the study of Thelin in pediatric PAH patients. The FDA Prescription Drug User Fee Act (PDUFA) target action date for Thelin is March 24, 2006.

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: July 14, 2005  /s/ Stephen L. Mueller    
  Stephen L. Mueller   
  Vice President, Finance and Administration
Secretary and Treasurer 
 

 


 

         

INDEX TO EXHIBITS

     
Exhibit No.   Description
 
   
99.1
  Press Release.

 

EX-99.1 2 h27014exv99w1.htm PRESS RELEASE exv99w1
 

Exh. 99.1

     
Investors:
  Media:
Ann Tanabe
  Dan Budwick
Encysive Pharmaceuticals
  BMC Communications
(713) 796-8822
  (212) 477-9007 ext. 14

Marcy Strickler
The Trout Group
(212) 477-9007 ext. 27

FOR IMMEDIATE RELEASE

ENCYSIVE ANNOUNCES PDUFA DATE FOR THELIN™ NEW DRUG
APPLICATION IN PULMONARY ARTERIAL HYPERTENSION

HOUSTON- July 14, 2005- Encysive Pharmaceuticals (NASDAQ:ENCY) today announced that the Cardio-Renal Division of the U.S. Food and Drug Administration (FDA), in correspondence with the Company, stated that it anticipates filing Encysive’s New Drug Application (NDA) for ThelinÔ (sitaxsentan) on July 23, 2005 under a standard review classification. Thelin 100 mg is being evaluated as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).

“We are pleased that the FDA plans to accept our NDA for Thelin. This is the largest database for a PAH orphan drug indication that has been submitted to the Cardio-Renal Division for initial marketing approval,” said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. “We are also pleased that the FDA has simultaneously requested a plan for the study of Thelin in pediatric PAH patients, a demographic with limited treatment options in which patient safety is paramount.”

The FDA Prescription Drug User Fee Act (PDUFA) target action date for Thelin is March 24, 2006.

About Thelin and PAH

Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.

Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart/lung or lung transplantation. PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide, many of whom are children and young women.

 


 

Exh. 99.1

The most frequent adverse events that occurred in patients receiving Thelin, which were more common than in placebo-treated patients, were headache, edema, nausea, upper respiratory tract infection, dizziness, insomnia, nasopharyngitis, and nasal congestion. Because Thelin inhibits the metabolism of warfarin, a decreased dose of warfarin is needed when co-administered with Thelin.

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. We have successfully developed one FDA-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia that is marketed by GlaxoSmithKline. Our lead drug candidate, Thelin (sitaxsentan sodium), is an endothelin receptor antagonist, and this NDA for the treatment of PAH is now under active review by the Cardio-Renal Division of the FDA. In addition, we have an earlier stage clinical product candidate in development, TBC3711, a next generation endothelin receptor antagonist. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.

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.

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