United Therapeutics Will Move Forward With FDA Filing For New Drug

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Aug 24 2011 - 2:17pm

One of the largest and most profitable biotechnology companies in the Mid-Atlantic is trying to increase its revenue by developing an oral form of treatment for pulmonary arterial hypertension (PAH).

Silver Spring-based United Therapeutics Corporation (NASDAQ: UTHR) released its FREEDOM-C(2) Phase 3 clinical trial results today but the company announced that the study did not meet its primary endpoint.

Oral treprostinil (treprostinil diethanolamine) is next in the pipeline of drugs to treat PAH, a condition that causes unusually high blood pressure in the heart arteries; leaving patients with shortness of breath under normal activities. Causes of the chronic illness can range from lung disease to HIV infection.

FREEDOM-C(2) included patients that currently use some sort of aid for their condition.

United Therapeutics said that the tablet form of treatment for PAH did not post any statistical significance in the FREEDOM-C(2) trial. Part of the study was to provide evidence that patients showed improvement in a six-minute walk distance at week 16. The phase three clinical trial which is typically the final test before FDA approval was a randomized, double-blind, placebo-controlled study that included 310 patients that were given Oral treprostinil or a placebo twice a day over 16-weeks.

But United Therapeutics believes that the positive results in its previously announced FREEDOM-M trial is sufficient to submit a filling to the FDA. The FREEDOM-M trial included patients who have not been aided by any background therapy in a 12-week study.

"While we did not achieve a statistically significant result for this trial, we believe the positive results from our previously-announced FREEDOM-M study support an NDA filing of oral treprostinil in treatment naive patients," stated Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "Given that treprostinil is already approved for use in PAH by subcutaneous, intravenous and inhaled routes of administration, we believe the data obtained from all FREEDOM trials support an NDA for oral treprostinil in this indication," continued Dr. Jeffs. "We will now focus on completing the NDA for filing by the first half of 2012."

United Therapeutics already has several drugs approved by the FDA and on the market to treat PAH. The company said in its second quarter 2011 financial report that it expects revenues of $750 Million for the full-year. It posted a profit of $73.9 Million or $1.27 per basic share for three months ended June 30, 2011 on revenues of $183.8 Million.

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