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Improved Long-Term Outcome With Remodulin Reported in European Respiratory Journal and Rapid Transition to Remodulin Reported in Journal of Cardiovascular Pharmacology

SILVER SPRING, MD -- February 1, 2007 -- United Therapeutics Corporation announced the publication of two important studies: Long-term outcome in pulmonary arterial hypertension patients with subcutaneous treprostinil (Eur Respir J 2006:1195-1203); and Rapid Switch from intravenous epoprostenol to intravenous treprostinil in patients with pulmonary arterial hypertension (J Cardiovasc Pharm 2007:49[1]: 1-5).

"These studies demonstrate our company's commitment to developing the best possible medicines," said Martine Rothblatt, PhD, United Therapeutics' Chairman and Chief Executive Officer. "They also evidence our strategic objective of conducting highly insightful clinical studies," Dr. Rothblatt concluded.

The long-term outcome study published in the European Respiratory Journal demonstrated improved survival with Remodulin therapy when compared to predicted survival (NIH formula) over a four-year period. One-, 2-, 3- and 4-year survival was 87%, 78%, 71%, and 68%, respectively, for all 860 patients (including 130 patients who received combination therapy), and 88%, 79%, 73%, and 70%, respectively, for patients receiving only Remodulin monotherapy (n=730).

In patients with idiopathic pulmonary arterial hypertension for whom baseline hemodynamics were available (n=332 patients), survival for patients receiving Remodulin was 91%, 82%, 76%, and 72% at Years 1 through 4, respectively. This compares to predicted survival estimates of 69%, 56%, 46%, and 38% over the four-year period based on the NIH registry formula.

"This is the largest, longitudinal clinical study ever conducted in patients with pulmonary arterial hypertension and we are pleased to see the positive effects of Remodulin therapy on the most critical clinical outcome, survival," said Roger Jeffs, PhD, United Therapeutics' President and Chief Operating Officer.

In addition, results reported this month in the Journal of Cardiovascular Pharmacology demonstrate that rapid transition from intravenous epoprostenol to intravenous Remodulin in 12 pulmonary arterial hypertension patients was achieved with no serious adverse events and baseline clinical status was maintained over 12 weeks. Patients were transitioned from epoprostenol to Remodulin by switching the medication cassette and avoiding a prolonged titration of the two medications.

"This important study demonstrates that transition from epoprostenol to Remodulin can be done safely with an easy process involving a rapid switch of the medication cassette," said David Zaccardelli, PharmD, Senior Vice President of Pharmaceutical Development. "For those patients transitioning to Remodulin, rapid switch allows the process to occur succinctly and without a prolonged period for the transition," said Dr. Zaccardelli.

United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life- threatening cardiovascular, cancer and infectious diseases.

Remodulin(R) is indicated as a continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.

Remodulin is indicated to diminish the rate of clinical deterioration in patients requiring transition from Flolan(R); the risks and benefits of each drug should be carefully considered prior to transition.

Important Safety Information:
Remodulin is contraindicated in patients with hypersensitivity to Remodulin, its ingredients, or similar drugs. Remodulin is a potent vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants.

Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of pulmonary arterial hypertension symptoms and should be avoided. Caution should be used in patients with hepatic or renal problems. The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects (>5% more than placebo) were diarrhea, jaw pain, vasodilation, and edema.


SOURCE: United Therapeutics Corporation

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