-----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, M0VhKztupCqg+5WcBawnyNrObiGRb1LDgP4LNBzm9P/0/SGKdogk7RihiVPnA3O2 XnzuTve5snrBfLXTfkTLVA== 0000950129-04-007838.txt : 20041018 0000950129-04-007838.hdr.sgml : 20041018 20041018071640 ACCESSION NUMBER: 0000950129-04-007838 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041018 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041018 DATE AS OF CHANGE: 20041018 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: 041082292 BUSINESS ADDRESS: STREET 1: 6700 WEST LOOP SOUTH STREET 2: 4TH FLOOR CITY: BELLAIRE STATE: TX ZIP: 77401 BUSINESS PHONE: 7137968822 FORMER COMPANY: FORMER CONFORMED NAME: TEXAS BIOTECHNOLOGY CORP /DE/ DATE OF NAME CHANGE: 19930328 8-K 1 h19176e8vk.txt ENCYSIVE PHARMACEUTICALS INC. - DATED 10/18/2004 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): October 18, 2004 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.) 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 - -------------------------------------------------------------------------------- (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 today that new clinical data on Thelin(TM) (sitaxsentan) will be presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Antonio (October 16-21). Results from a subgroup analysis of the 178-patient pivotal Phase IIb/III STRIDE-1 (Sitaxsentan To Relieve ImpaireD Exercise) will be discussed showing the positive impact of Thelin upon patients with pulmonary arterial hypertension (PAH) related to connective tissue diseases, such as scleroderma and lupus, during a scientific session to take place on Thursday, October 21, at 9 a.m. 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: October 18, 2004 /s/ Stephen L. Mueller ------------------------------------------ Stephen L. Mueller Vice President, Finance and Administration Secretary and Treasurer Index To Exhibits (c) Exhibits. 99.1 Press Release. EX-99.1 2 h19176exv99w1.txt PRESS RELEASE Exhibit 99.1 Contact: Investors: Media: Ann Tanabe Daniel Budwick Encysive Pharmaceuticals BMC Communications (713) 796-8822 (212) 477-9007 ext. 14 Hershel Berry The Trout Group (415) 392-3385 FOR IMMEDIATE RELEASE NEW THELIN(TM) DATA PRESENTED AT AMERICAN COLLEGE OF RHEUMATOLOGY MEETING Study Shows Improvements in Six-Minute Walk Distance and NYHA Functional Class in Patients with Pulmonary Arterial Hypertension Related to Connective Tissue Diseases Data to be Highlighted at ACR Press Conference HOUSTON - OCTOBER 18, 2004- Encysive Pharmaceuticals (NASDAQ: ENCY) today announced that new clinical data on Thelin(TM) (sitaxsentan) will be presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Antonio (October 16-21). Results from a subgroup analysis of the 178-patient pivotal Phase IIb/III STRIDE-1 (Sitaxsentan To Relieve ImpaireD Exercise) will be discussed showing the positive impact of Thelin upon patients with pulmonary arterial hypertension (PAH) related to connective tissue diseases, such as scleroderma and lupus, during a scientific session to take place on Thursday, October 21 at 9 a.m. In the study, entitled "Sitaxsentan Improves 6MW in Patients with Pulmonary Arterial Hypertension (PAH) Related to Connective Tissue Diseases (CTD)," 42 patients diagnosed with PAH related to a CTD were assessed for a period of 12 weeks. The treatment effect upon six-minute walk distance (6MW), the standard measurement of function in patients with PAH, was 58 meters. In addition, 24 percent of the patients in the treatment group improved one New York Heart Association (NYHA) functional class. "Thelin significantly improved the key efficacy variable of six-minute walk, as well as hemodynamics such as cardiac index and pulmonary vascular resistance in patients with PAH related to CTD," said Vallerie McLaughlin, M.D., University of Michigan Hospital, Ann Arbor, Michigan and lead investigator of the study. "The availability of this once daily, well tolerated, oral therapy represents an important treatment advance over other agents, some of which require a more complicated, intravenous delivery system." Exhibit 99.1 Note: Dr. McLaughlin's Thelin data in CTD will be highlighted today at 1:30 p.m. in an ACR press conference, entitled, "Scleroderma and Lupus: New Clinical Information and Treatment Options." MORE STUDY DETAILS In the multicenter, randomized, double-blind, placebo-controlled study, patients in the treatment group (n=33) received an oral dosage of either 100 mg or 300 mg of Thelin once daily for 12 weeks, while the control group (n=9) received a placebo. At baseline, all CTD patients were NYHA Class II or III, and had a 6MW distance of 356 meters. After 12 weeks, 6MW treatment effect was 58 meters (p= 0.0274), due to both an increase in 6MW by 20 meters in the treatment group from baseline (p=0.0327) and a decrease in 6MW by 38 meters in the placebo group from baseline. Eight of 33 patients receiving Thelin also improved by one NYHA functional class on Thelin, compared with one of nine placebo patients. Thelin was well tolerated and no liver function abnormalities or serious adverse events were observed. "The positive findings from this STRIDE-1 subgroup analysis help further differentiate Thelin and its potential from any other drug in this category," said Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "We will continue with our strategy to explore Thelin's full therapeutic potential by evaluating it across the broadest population possible." ABOUT CONNECTIVE TISSUE DISEASE Scleroderma, lupus and related connective tissue diseases are chronic inflammatory autoimmune diseases that can damage the blood vessels of the lungs and other organs. Together, scleroderma and lupus alone affect over 1,800,000 people in the United States. PAH is a common, devastating complication of these diseases. For more information on scleroderma and lupus, visit the Scleroderma Foundation at www.scleroderma.org and the Lupus Foundation of America at www.lupus.org. 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. 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 and lung transplant. Primary and secondary PAH are estimated to afflict approximately 80,000 to 100,000 people worldwide, many of whom are children and young women. Exhibit 99.1 Side effects of Thelin seen in the program to date, and which occurred more frequently than in placebo, include liver dysfunction (increased ALT and AST), headache, edema, constipation, nasal congestion and flushing. Because Thelin inhibits the metabolism of warfarin, the dose of warfarin should be adjusted downward when co-administered with Thelin. ABOUT ENCYSIVE PHARMACEUTICALS Encysive Pharmaceuticals Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for our expertise in small molecule drug development and vascular biology. Argatroban, our first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Encysive Pharmaceuticals is in Phase III development of the endothelin antagonist, Thelin, for pulmonary arterial hypertension. Our majority-owned affiliate, Revotar Biopharmaceuticals AG, is in Phase II development with the selectin antagonist bimosiamose in asthma, psoriasis and atopic dermatitis. Encysive Pharmaceuticals has several other research and development programs ongoing for a range of cardiovascular and inflammatory diseases. To learn more about Encysive Pharmaceuticals please visit our web site: 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 timing and cost of our clinical trials, attainment of research and clinical goals and milestones of product candidates, attainment of required government approvals, sales levels of our products and availability of financing and revenues sufficient to fund development of product candidates and operations. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive Pharmaceuticals, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. The Company undertakes no duty to update or revise these forward-looking statements. # # # -----END PRIVACY-ENHANCED MESSAGE-----