Encysive launches Thelin in U.K.; remains hopeful U.S. launch will follow soon

By Jennifer Lanning Drey

Portland, Ore., Nov. 6 - Encysive Pharmaceuticals, Inc. launched Thelin (sitaxentan sodium) for the treatment of pulmonary arterial hypertension (PAH) in the United Kingdom on Monday, according to Bruce Given, the company's chief executive officer, who also gave a presentation Monday at the Rodman & Renshaw 8th Annual Healthcare Conference.

The launch represents Encysive's first commercial activity for Thelin, which gained regulatory approval in all 25 countries of the European Union in August.

"We're thrilled to be now commercially available in our first market worldwide," Given said.

The company expects to also launch Thelin in Germany in the fourth quarter, with other key European countries to follow over the course of 2007, depending on the timing of the reimbursement process, he said.

In the United States, Encysive remains hopeful that Thelin will gain regulatory approval without requiring additional clinical trials, Given said. The company submitted a response last week to the Food and Drug Administration's second approvable letter for Thelin, which it received in July.

Given said the response was based on conversations with FDA officials, and the company expects to receive notification within 30 days on the next steps for Thelin in the United States.

Encysive estimates that there are between 100,000 and 200,000 PAH patients in North America and Europe, and the company believes the number of patients diagnosed with the disease will double by 2009, Given said.

"We don't see the disease having been penetrated from a treatment perspective until some time into the next decade," he said.

In addition to preparing for launch activities related to Thelin, Encysive also is studying the drug's potential in the treatment of diastolic heart failure and other undisclosed indications, Given said.

Encysive is a biopharmaceutical company based in Houston that develops small molecule compounds.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.