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12:00 AM
 | 
Nov 24, 2008
 |  BioCentury  |  Product Development

Short walk becomes long march

United Therapeutics Corp. paid the price last week for having skipped Phase II when its oral treprostinil did not improve six-minute walk time in a Phase III trial in pulmonary arterial hypertension. The company attributed the failure - which will delay its internal program by about 18 months - to a suboptimal dose-titration regimen. To plug the gap, it announced that it had licensed U.S. rights to tadalafil PDE-5 inhibitor for PAH from Eli Lilly and Co.

Remodulin treprostinil, a prostacyclin analog, was approved in the U.S. in 2002. According to Andrew Fisher, SVP of investor relations and deputy general counsel for United Therapeutics, the drug has more than an 80% share of the late stage PAH market, which had been dominated by Flolan epoprostenol from GlaxoSmithKline plc. Remodulin's ability to be given intravenously or subcutaneously and its stability at room temperature gave it a leg up on Flolan, which is delivered intravenously and requires constant refrigeration.

But the convenience of oral drugs meant Remodulin had little chance of making inroads into earlier stage patients.

First-line therapy for earlier stage patients is dominated by three oral drugs: Revatio sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor from Pfizer Inc., and the endothelin receptor antagonists Tracleer bosentan from Actelion Ltd. and...

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