GILD Gilead Sciences Inc

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.�

About ARIES-3

ARIES-3 was an open-label, single-arm, multicenter, Phase III study designed to evaluate the efficacy and safety of ambrisentan in a broader PH population than was studied in the ARIES-1 and ARIES-2 studies. The study enrolled 224 patients with WHO Group 1 PAH (n=140) or PH due to other etiologies (n=84), including 23 patients with PH secondary to chronic obstructive pulmonary disease (PH-COPD) (WHO Group 3), 21 patients with PH secondary to interstitial lung disease (PH-ILD) (WHO Group 3) and 29 patients with PH due to chronic thromboembolic disease (CTEPH) (WHO Group 4). Patients received ambrisentan at a dose of 5 mg once daily until the primary analysis of efficacy at 24 weeks. The primary endpoint was the change from baseline in 6MWD at Week 24. Secondary objectives were to evaluate the effects of ambrisentan on other clinical measures of PH, including the number of patients still alive at specified time points and time to clinical worsening, which was defined as the time from initiation of ambrisentan to the first occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid therapy or sildenafil due to protocol-defined worsening criteria or study withdrawal due to addition of other PH medications. In addition, the safety and tolerability of ambrisentan was evaluated in the overall study population and in various subgroups.

At baseline, 29 percent of patients were classified as having WHO functional class II symptoms and 65 percent of patients had WHO functional class III symptoms. The mean baseline 6MWD for patients was 317�84 meters. At baseline, 52 percent of all patients were receiving sildenafil and/or prostanoid therapy. Twenty-seven patients in the study had previously discontinued use of bosentan and/or sitaxsentan due to liver enzyme (aminotransferase) elevations greater than three times the upper limit of normal (ULN).

In the overall study population, patients experienced a mean 6MWD improvement of 21 meters (95 percent CI: 11.8 to 29.3; p

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