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Press Release

New Data for Gilead Sciences' Ambrisentan Show Clinical Improvements in a Diverse Pulmonary Hypertension (PH) Population

Posted on: 19 May 09

SAN DIEGO(BUSINESS WIRE)May. 18, 2009 Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from ARIES-3, an open-label, single-arm, Phase III study evaluating the efficacy and safety of ambrisentan in patients with pulmonary hypertension (PH), which showed a mean 21-meter improvement from baseline in six-minute walk distance (6MWD) at 24 weeks. Ambrisentan is approved under the tradename Letairis® (ambrisentan 5 mg and 10 mg tablets) as a once-daily treatment for pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening. The ARIES-3 study included patients with PAH (WHO Group 1) as well as patients with pulmonary hypertension due to other etiologies (WHO Groups 3, 4 and 5). Data from this study were presented today at the 2009 American Thoracic Society (ATS) International Conference, taking place May 15-20 in San Diego.

“In previous clinical trials, ambrisentan has been shown to improve exercise capacity and delay clinical worsening in WHO Group 1 PAH patients with WHO functional class II and III symptoms,” said David Badesch, MD, Professor of Medicine and Clinical Director of the Pulmonary Hypertension Center at the University of Colorado Health Sciences Center and lead study author. “However, many patients seen in clinical practice have pulmonary hypertension associated with other diseases. ARIES-3 is important because it represents the first safety and efficacy data for ambrisentan in a more diverse PH patient population, including patients already on background therapy.”

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