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FREEDOM-M Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Meets Primary Endpoint
Date:6/6/2011

;The FREEDOM-M trial presents a potentially transformative opportunity to extend treprostinil across all available approved routes of administration.”

“These results build upon the treprostinil franchise we have established with Remodulin and Tyvaso.  We are excited that the primary efficacy analysis of this trial confirms the benefits of oral treprostinil on 6MWD, as the delivery of treprostinil via a twice daily oral tablet, if it secures regulatory approval, would provide a critically important additional treatment option for patients with this severe disease,” said Roger Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics.  “We will now focus our energies on finishing our FREEDOM-C(2) trial and completing the necessary regulatory filings next year so that patients can have access to oral treprostinil as a prescribed route of delivery.”

The 313-patient FREEDOM-C(2) trial is studying oral treprostinil in PAH patients who are receiving an endothelin receptor antagonist and/or a PDE-5 inhibitor.  Preliminary analysis of the results of the trial are expected to be announced in September 2011.

Further review and analysis of the FREEDOM-M 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 6:00 a.m. Eastern Time on June 6, 2011.  Full data from FREEDOM-M will be presented at an upcoming medical meeting and will also be available through the publication of peer-reviewed journal articles.

Conference Call

On Monday, June 6, 2011 at 9:00 a.m. Eastern Time, Lewis J. Rubin, MD, FCCP, the Chair of the FREEDOM-M Steering Committee and Professor Emeritus of Medicine at University of California San Diego Medical Center, will join United Therapeutics’ mana
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SOURCE United Therapeutics Corporation
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