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business newsUnited Therapeutics Plunges on Missed Study Goal
By
Brett Chase
Aug 24, 2011 2:15 pm
The company still plans to apply for FDA approval of an oral lung drug by using older trial data.
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So maybe it shouldn’t come as a surprise that the company says it's going ahead and applying to sell an oral version of its drug treprostinil even though the treatment missed a late-stage study goal of helping PAH patients walk. Investors aren’t keen on the prospects. Shares of the company plunged Wednesday.
Roger Jeffs, United Therapeutics’ president and chief operating officer, says the company will submit older study data as part of the company’s US application to sell an oral treatment. The drug already is approved in inhaled and intravenous forms, sold under the brand names Tyvaso and Remodulin.
An oral form of the drug would be a substantial product for the company, significantly increasing its value.
RBC Capital Markets analyst Michael Yee estimates the stock is worth $65 a share if United Therapeutics can win approval for the oral treatment. Of course, approval appears to be a big “if” now. Yee has a hold rating on the stock.
In midday trading, United Therapeutics shares fell 18% to $40.05. The stock is down 14% over the past year.
The company said its early analysis of the 310-patient study results found that the trial didn’t meet its endpoint of improving distance in a six-minute walk in the 16th week of the study. The company plans to file its application with the Food and Drug Administration in the first half of next year. Click here for a detailed slide presentation on the research.
“While we did not achieve a statistically significant result for this trial, we believe the positive results from our previously announced (drug) study support” an FDA filing, Jeffs says in a statement.
United Therapeutics went from a money-losing company in 2008 to $106 million in net income last year on about $604 million in sales. Remodulin, approved by the FDA in 2002, makes up almost 70% of sales. Tyvaso was approved in 2009.
Twitter: @brettchase
No positions in stocks mentioned.
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