UPDATE 3-United Therapeutics' oral PAH drug fails trial

lunedì 17 novembre 2008 20:13

(Adds analysts' comments, updates stock movement)

By Esha Dey

BANGALORE Nov 17 (Reuters) - United Therapeutics Corp (UTHR.O: Quotazione) said a late-stage trial of its experimental oral treatment for pulmonary arterial hypertension (PAH) failed to meet the main goal of the study, sending its shares tumbling 36 percent to a new year-low.

The drug being tested is an oral formulation of Remodulin, a hormone present in the human body that is classified as prostacyclin. Injectable Remodulin is already approved for PAH, a condition that causes high blood pressure in vessels connecting the lungs to the heart.

Ladenburg Thalmann & Co analyst Matthew Kaplan said the investors were looking for an oral version of prostacyclin as its other forms are very tough to administer.

Prostacyclin is usually used in the sickest of PAH patients and an oral version of the drug could be used in early treatment, Kaplan said.

However, analysts are still positive on oral Remodulin and they believe the main reason for the "disappointing" data was that about one-third of the patients failed to reach the required therapeutic dose.

Monday's data also means that the drug's approval gets pushed further away.

"Had this trial and the next succeeded, they probably could have submitted for approval sometime mid-year next year," Cowen and Co analyst Philip Nadeau said. "But now they are talking about submitting for approval late in 2010. So, it's probably done an eighteen months delay."   Continua...