HOUSTON, June 2 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a positive opinion recommending the approval of Thelin(TM) (sitaxentan sodium) 100 mg tablets as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).
The CHMP recommended approval of Thelin for the treatment of patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
The CHMP’s positive opinion will now be considered by the European Commission, which is expected to issue a final decision regarding marketing approval for Thelin within approximately 90 days. Under the EMEA’s centralized licensing procedure, if approved, Encysive would be granted marketing authorization for Thelin in all 25 member states of the European Union.
About Thelin(TM) (sitaxentan sodium) and PAH
Thelin(TM) (sitaxentan sodium*) 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. Sitaxentan sodium 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.
The most frequent adverse events that occurred in patients receiving sitaxentan sodium, which were more common than in placebo-treated patients, were headache, edema, nausea, upper respiratory tract infection, dizziness, insomnia, nasopharyngitis, and nasal congestion. Because sitaxentan sodium inhibits the metabolism of warfarin, a decreased dose of warfarin is needed when co-administered with sitaxentan sodium. In addition, monthly testing for liver function and pregnancy testing for females of childbearing potential is required for patients receiving sitaxentan sodium.
* “Sitaxentan” sodium is the spelling recognized by the World Health Organization for Encysive Pharmaceuticals’ sitaxsentan sodium.
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 .
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 decisions by regulatory authorities regarding whether and when to approve our drug applications for Thelin(TM) (sitaxsentan sodium),and their decisions regarding labeling and other matters that could affect the availability and commercial potential of Thelin, and the speed with which regulatory authorizations and approvals could be achieved, as well as more specific 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.
Encysive Pharmaceuticals Inc.
CONTACT: Ann Tanabe, VP, Investor Relations and Corporate Communicationsof Encysive Pharmaceuticals Inc., +1-713-796-8822; or Dan Budwick of BMCCommunications, +1-212-477-9007 ext. 14; or Marcy Strickler of The TroutGroup, +1-212-477-9007 ext. 27, both for Encysive Pharmaceuticals Inc.
Web site: http://www.encysive.com/
