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FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
Date:5/26/2009

Conference Call to be Held at 9:00 a.m. Eastern Time Today, May 26, 2009

SILVER SPRING, Md., May 26 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.

"Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "The FDA's action in approving once-a-day ADCIRCA is a big plus for all three P's: patients, physicians and payors."

In the PHIRST-1 randomized, double-blind, 16-week placebo-controlled Phase 3 clinical trial of ADCIRCA for PAH, patients taking ADCIRCA 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, PHIRST-1 patients taking ADCIRCA 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushin
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