Encysive to sell Thelin in Europe

By Elaine Rigoli

Tampa, Fla., Aug. 11 - Encysive Pharmaceuticals, Inc. said it has received the formal decision letter from the European Commission granting marketing authorization for Thelin (sitaxentan sodium) 100 mg tablets.

Thelin is indicated for the treatment of patients with pulmonary arterial hypertension classified as World Health Organization functional class 3, to improve exercise capacity. The company said efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

The European Commission's centralized licensing procedure permits Encysive to market Thelin in all 25 member states of the European Union.

Thelin's approval is based on the largest database of patients with pulmonary arterial hypertension ever assembled in an original marketing authorization application, with more than 1,000 pulmonary arterial hypertension patients receiving Thelin, the company said in a news release.

"With this approval, we celebrate an important milestone for Encysive and the Thelin development program. 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," president and chief executive officer Bruce D. Given said in the release.

Encysive is a biopharmaceutical company based in Houston.

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