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FREEDOM-C(2) Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Does Not Meet Primary Endpoint
Date:8/24/2011

ce daily in the oral treprostinil group. Discontinuations due to adverse events were 18 (11%) and 5 (3%) in the treprostinil and placebo groups, respectively. Adverse events associated with discontinuations were typically prostacyclin-related effects including headache, nausea and vomiting.

Preliminary analysis of other secondary efficacy measures, including time to clinical worsening, change in combined 6MWD and Borg Dyspnea Score rating (shortness of breath test) and Dyspnea-Fatigue index, WHO functional class, and PAH signs and symptoms, did not differ significantly between oral treprostinil and placebo (p>0.05).

Further review and analysis of the FREEDOM-C(2) preliminary results are ongoing.  A summary of the preliminary analysis conducted thus far can be accessed via United Therapeutics' website at http://ir.unither.com/events.cfm beginning at 5:00 a.m. Eastern Time on August 24, 2011.  Full data from FREEDOM-C(2) will be presented at an upcoming medical meeting and will also be available through the publication of peer-reviewed journal articles.

"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," said 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," added Dr. Jeffs. "We will now focus on completing the NDA for filing by the first half of 2012."

Conference Call

On Wednesday, August 24, 2011 at 9:00 a.m. United Therapeutics will host a one-hour conference call to answer questions related to FREEDOM-C(2).

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