HOUSTON, Oct. 11, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced the commercial availability of THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in France for the treatment of pulmonary arterial hypertension (PAH). Encysive received European Union (EU) marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with PAH.
THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).
The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the EU. THELIN has already been launched in the United Kingdom, Germany, Ireland, Spain and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
"Our European commercialization strategy continues as planned with the availability of THELIN to physicians and patients in France," said Thierry Plouvier, M.D., Vice President, Europe Operations, for Encysive (UK) Ltd. "THELIN is now available in 4 of the big 5 EU countries, adding an additional therapeutic option for the treatment of pulmonary arterial hypertension to a significant share of patients in the EU."
Important Safety Information
In placebo-controlled clinical trials, the most frequent adverse events that occurred in patients receiving THELIN, which were considered to possibly be related to THELIN treatment, were headache, peripheral edema and nasal congestion. Other adverse events that occurred in at least 2% of THELIN patients, at a rate greater than placebo and considered to possibly be related to THELIN treatment, included dizziness, constipation, epistaxis, flushing, international normalized ratio (INR) increase, insomnia, nausea, upper abdominal pain, vomiting, dyspepsia, diarrhea, fatigue, muscle cramp, and prothrombin time (PT) prolongation. THELIN is also associated with liver function abnormalities. Because THELIN inhibits the metabolism of warfarin and other vitamin K antagonists, a dose adjustment for these drugs is needed when co-administered with THELIN. THELIN and other endothelin receptor antagonists have potential for liver toxicity and are teratogenic. Testing of liver enzymes is required prior to the initiation of THELIN and monthly thereafter. THELIN should not be used during pregnancy unless clearly necessary. THELIN is contraindicated in patients receiving cyclosporine A, patients with mild to severe hepatic impairment (Child-Pugh Class A-C), patients with elevated liver aminotransferases prior to starting treatment (elevation in liver enzymes to levels greater than 3 times the upper limit of normal), lactating patients, or patients with hypersensitivity to the active substance or any excipients.
About PAH
It is estimated that PAH afflicts approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. Since the heart must then pump harder to overcome the resistance, patients are susceptible to heart failure.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a global 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. To learn more about Encysive Pharmaceuticals please visit our web site: www.encysive.com.
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(1) THELIN is an EU registered trademark of Encysive Pharmaceuticals
Inc.
(2) "Sitaxentan" sodium is the spelling recognized by the World
Health Organization for Encysive Pharmaceuticals' sitaxsentan
sodium.
(3) Primary pulmonary hypertension is also known as idiopathic
pulmonary arterial hypertension.
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 reduced estimates concerning the size of the PAH patient population and PAH diagnosis rates in France and the EU; our ability to quickly and successfully commercialize THELIN in France and other countries of the EU; market acceptance of THELIN in France and the actual rate of acceptance; the speed with which pricing and reimbursement approvals and product launches for THELIN may be achieved in other countries of the EU; difficulties or delays in manufacturing, packaging or distributing THELIN in France; legislation or regulations within the EU affecting THELIN's pricing, reimbursement or access; the scope of our patents for THELIN and our ability to protect our patents and other intellectual property for THELIN in France and the EU; our estimate of the sufficiency of our existing capital resources; our ability to attract and retain qualified personnel; our ability to raise additional capital to fund cash requirements for our EU commercial requirements; our inability to predict revenues from sales of THELIN in France and other countries of the EU; and our ability to earn a profit from sales of THELIN in France and other countries in the EU as well as other risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.