Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets ... ( Data Findings Published in June Issue...)

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Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

Date:6/9/2009

Data Findings Published in June Issue of Circulation

SILVER SPRING, Md. and INDIANAPOLIS, June 9 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) and Eli Lilly and Company (NYSE: LLY) today announced the results of a pivotal 16-week study showing that a once-daily dose of tadalafil was generally well tolerated, improved exercise capacity and improved time to clinical worsening in patients with pulmonary arterial hypertension (PAH)(1). The randomized, double-blind, 16-week, placebo-controlled Phase 3 study followed 405 patients with PAH, either treatment-naive or taking bosentan, randomized to placebo or tadalafil 2.5 mg, 10 mg, 20 mg or 40 mg orally. Results from the study entitled, "Tadalafil Therapy for Pulmonary Arterial Hypertension," were published in today's issue of Circulation.

The study formed the basis of the United States Food and Drug Administration (FDA) approval to market tadalafil tablets for the treatment of PAH under the brand name ADCIRCA(TM).

"PAH is a rare, life-threatening disease," said lead investigator Dr. Nazzareno Galie, Associate Professor of Cardiology at the University of Bologna and head of the Pulmonary Hypertension Centre at the Institute of Cardiology. "The results of this study are encouraging for PAH clinicians and the patients they treat."

About the Study

The randomized, double-blind, 16-week, placebo-controlled Phase 3 study monitored 405 patients with idiopathic PAH or PAH associated with anorexigen use, connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital systemic-to-pulmonary shunts.

Patients were randomized in groups and received one of five treatments, tadala
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SOURCE United Therapeutics Corporation
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