European Commission Grants First Selective, Once Daily Oral Endothelin A Receptor Antagonist Approval in All 25 European Union Member States Conference Call Scheduled for Monday, August 14th at 8:00 a.m. ET
HOUSTON, August 11, 2006 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced that the Company has received the formal decision letter from the European Commission granting marketing authorization for THELIN(R)(1) (sitaxentan sodium(2)) 100 mg tablets. THELIN is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as World Health Organization (WHO) functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease. THELIN is the first selective endothelin A receptor antagonist, and first once daily oral treatment available for patients with PAH. The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 25 member states of the European Union.
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.
"PAH is a serious and complex disease that often requires different therapeutic approaches for treatment success," said Nazzareno Galie, M.D., Associate Professor of Cardiology, Institute of Cardiology, University of Bologna, Bologna, Italy. "The approval of THELIN provides a new option that can be included in the treatment algorithms for PAH."
"Clinical studies conducted with THELIN suggest a benefit for patients who have idiopathic pulmonary arterial hypertension or who have developed pulmonary hypertension as a result of a connective tissue disease, such as scleroderma," said Robert Naeije, M.D., Professor of Pulmonary Medicine, Erasmus University Hospital, Brussels, Belgium.
THELIN's approval is based on the largest database of patients with PAH ever assembled in an original Marketing Authorization Application (MAA), with more than 1,000 PAH patients receiving THELIN.
"With this approval, we celebrate an important milestone for Encysive and the THELIN development program," commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "Our immediate focus is to make THELIN commercially available in the United Kingdom and Germany, the first E.U. launch countries, with subsequent launches in other member states as government approval for reimbursement is obtained."
THELIN(R) (Sitaxentan Sodium) Efficacy Highlights
Encysive conducted two randomized, placebo-controlled, multi-center pivotal Phase III studies in support of worldwide product registrations, STRIDE-1 and STRIDE-2 (Sitaxsentan To Relieve ImpaireD Exercise).
In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease.
Important Safety Information
In placebo-controlled clinical trials, the most frequent adverse events that occurred in patients receiving THELIN, which were considered to be possibly 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 be possibly 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.
THELIN(R) (Sitaxentan Sodium) Overview
THELIN is an endothelin A receptor antagonist, 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. Highly selective endothelin A receptor antagonism has been shown to increase blood flow and reverse vasoconstriction in human clinical pharmacology studies.
In 2004, the European Commission granted Encysive orphan medicinal product designation for THELIN in PAH. This status provides companies that develop and market therapies for rare diseases and disorders with market exclusivity for a particular indication for a period of ten years from marketing authorization.
For more information, please visit www.encysive.com.
(1) THELIN is an E.U. 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.
Conference Call Information
Encysive will host a conference call to discuss the European Commission's marketing authorization of THELIN on Monday, August 14, 2006 at 8:00 a.m. ET. You may access the call either through the call-in number below or through the audio webcast. Please dial-in 15 minutes prior to the start time to allow for call processing. The access number for the call is:
Number: (703) 639-1173 Passcode: Encysive Pharmaceuticals
This call is being webcast and can be accessed via Encysive's web site at www.encysive.com.
A replay of the webcast will be available on the Company's web site through September 14, 2006. Additionally, a replay of the call will be available from Monday, August 14, 2006 at 11:30 a.m. ET until Thursday, August 17, 2006 at 11:59 p.m. ET. The call replay can be accessed by calling:
Number: (320) 365-3844 Access Code: 839561
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. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.
The Encysive Pharmaceuticals Inc. logo is available at http://media.primezone.com/prs/single/?pkgid=843
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 estimates concerning the PAH patient population; Encysive's ability to quickly and successfully commercialize THELIN in the European Union; market acceptance of THELIN and the actual rate of acceptance; the speed with which pricing and reimbursement approvals, and product launches for THELIN may be achieved in countries within the European Union; competitive product developments in the PAH disease market that may affect THELIN; difficulties or delays in manufacturing, packaging or distributing THELIN; the impact of existing and future European Union regulatory provisions on product exclusivity, including orphan drug exclusivity; legislation or regulations in countries within the European Union affecting THELIN's pricing, reimbursement or access; Encysive's ability to protect its patents and other intellectual property for THELIN; 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.