HOUSTON, Dec. 14, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced guidance for sales of THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets for 2007 and 2008. THELIN is the first selective endothelin A receptor antagonist, and the first once-daily oral treatment available for patients with Pulmonary Arterial Hypertension (PAH) in the European Union (EU).
Encysive received EU marketing authorization for THELIN from the European Commission in August 2006. In November, Encysive received reimbursement in Italy, making THELIN available in the five largest EU markets. THELIN was also approved in Canada and Australia in 2007.
Encysive will report its fourth quarter and full-year 2007 financial results on Wednesday, March 5, 2008. At that time, the Company expects to report 2007 sales of THELIN in the range of approximately $10.5 million to $11.5 million. 2008 will mark the first full year that THELIN will be available in the five largest EU markets. Encysive expects to record sales of THELIN for 2008 in the range of approximately $40 million to $50 million.
As previously announced on July 17, 2007, Encysive engaged the investment banking firm of Morgan Stanley to assist in evaluating the Company's assets and strategic alternatives to maximize stockholder value. The Company is in active discussions with several companies regarding strategic alternatives, and the process is ongoing.
The Company does not expect to publicly disclose further information regarding the status of the review of strategic alternatives until a definitive transaction is entered into or the process is completed. There can be no assurances that any particular alternative will be pursued or that any transaction will occur, or on what terms, or as to the timing of any transaction.
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, France, Italy and the Netherlands and will be launched in additional EU member states as local governmental approval for reimbursement is obtained.
Encysive is scheduled to give a presentation at the JP Morgan 26th Annual Healthcare Conference, on Thursday, January 10, 2008, in San Francisco. Details for the webcast will be made available at a later date.
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: market acceptance of Thelin(tm) in the EU, Canada and Australia and the actual rate of acceptance; the impact of reimbursement policies and governmental regulation of prices for Thelin(tm) in the EU, Canada and Australia; our ability to predict revenues from Thelin(tm) in the EU, Canada and Australia, and our expense levels, in 2007 and 2008; the speed with which pricing and reimbursement approvals and product launch of Thelin(tm) may be achieved; unexpected delays in regulatory approval of Thelin(tm) by the FDA in the U.S. and our other products under development, including TBC3711; the unpredictability of the duration and results of regulatory review of new drug applications and investigational new drug applications by the FDA; our estimate of the sufficiency of our existing capital resources; our ability to raise additional capital to fund cash requirements for future operations; our ability to execute our revised strategic plan and the impact of reducing our workforce on our strategic plan; our ability to enter into or consummate a definitive transaction as a result of evaluation of strategic alternatives or our ability to maximize stockholder value through this process; the actual costs incurred in our restructuring; and our ability to attract and retain key personnel, 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.