Friday, June 02, 2006

Encysive's Thelin High Blood Pressure Drug Gets European Advisory Panel Recommendation

HOUSTON -- Biotech drug maker Encysive Pharmaceuticals Inc. (NASDAQ ENCY) said Friday that a European advisory panel recommended that regulators approve Thelin to treat a type of high blood pressure.

The company's shares rose 93 cents, or 21.5 percent, to $5.25 in premarket trading.

The Committee for Medicinal Products for Human Use recommended that the European Agency for the Evaluation of Medicinal Products approve a once-a-day 100 milligram tablet version of Thelin for pulmonary arterial hypertension, or chronic high blood pressure in the blood vessel that carries oxygen-poor blood to the lungs. The condition causes shortness of breath, lowered activity, and eventually death unless treated with a transplant of the heart, lungs, or both.

The regulatory agency is expected to make a decision on whether or not to approve Thelin within 90 days.

In late May, the company submitted data to the Food and Drug Administration for the drug after the agency said Thelin was "approvable" but it needed more data. The company expects to hear back from the FDA by the end of June.

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