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EU agency backs Gilead's rival drug to Tracleer

Thu Feb 21, 2008 12:07pm EST

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LONDON, Feb 21 (Reuters) - The European Medicines Agency has recommended approval of Gilead Sciences Inc (GILD.O) and GlaxoSmithKline Plc's (GSK.L) drug ambrisentan, also known by the brand names Volibris and Letairis.

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The London-based watchdog said on Thursday that the medicine -- a rival to Actelion's (ATLN.VX) top-seller Tracleer -- had been recommended for treating pulmonary arterial hypertension, a rare lung and heart condition.

Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.

The medicine is already on sale in the United States and analysts had been expecting a European launch in the second half of 2008.

It will be the third so-called endothelin receptor antagonist drug to reach the market in Europe, behind Tracleer and Encysive Pharmaceuticals Inc's ENCY.O Thelin. Pfizer Inc (PFE.N) agreed to buy Encysive for $195 million on Wednesday.

Glaxo has licensed rights to sell Gilead's product outside the United States. (Reporting by Ben Hirschler)



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