UTHR hit almost 52 weeks low level-$40 on failure of oral version:
United Therapeutics down as drug misses study goal
United Therapeutics says oral treprostinil missed goal in late-stage trial, and stock sinks
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UTHR 40.13 -8.62
On Wednesday August 24, 2011, 11:35 am EDT
NEW YORK (AP) -- United Therapeutics Corp. said Wednesday that its blood pressure drug treprostinil did not work better than a placebo in a late-stage clinical trial.
Analysts said the results make it less likely the Food and Drug Administration will grant marketing approval for the drug. United Therapeutics reported successful results from a separate late-stage trial in June, and the company said it still plans to file for approval in the first half of 2012.
Shares of United Therapeutics lost $8.30, or 17 percent, to $40.45 in morning trading.
The latest study was designed to evaluate oral treprostinil as a treatment for pulmonary arterial hypertension, or high blood pressure in the lungs. The patients were treated with standard therapies and either oral treprostinil or a placebo. Researchers measured how far the patients could walk in six minutes at the start of the trial, and took another measurement after 16 weeks. United Therapeutics said the patients who were given treprostinil could not walk farther than patients treated with the placebo.
The drug also did not meet secondary goals like reducing shortness of breath or fatigue, or treating other symptoms. There were 310 patients in the study. The company said that at the start of the trial, the patients' median walking distance was 333 meters, or almost 1,100 feet, in six minutes. United Therapeutics said the most common side effects of treprostinil were headache, nausea, and vomiting, and 18 treprostinil patients left the trial because of those or other side effects. Five patients from the placebo group left the trial before it finished.
In the other late-stage trial, United Therapeutics said patients treated with oral treprostinil were able to walk farther than patients who received a placebo after 12 weeks of treatment. The Silver Spring, Md., company already sells an injectable version called Remodulin and an inhaled version called Tyvaso.
Citi Investment Research analyst Lucy Lu said Wednesday's data "significantly lowers the probability of approval." Lu wrote in June that the results from the previous trial were "good, but not great." She maintained a "Buy" rating on the stock with a price target of $71 per share.
Collins Stewart analyst Salveen Richter said she was also not sure the data from the two studies would convince the FDA to approve oral treprostinil. Richter noted that the patients in the second trial were generally sicker than those in the first trial.
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