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Gilead Announces Achievement of Primary Efficacy Endpoint in Second,Phase III Study of Aztreonam Lysine for Inhalation in Patients With,Cystic Fibrosis

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 29, 2007 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) met its primary efficacy endpoint of change at Day 28 from baseline in respiratory symptoms, as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool used to measure health-related quality of life for people with CF. Data from the 164-patient, double-blinded, randomized study demonstrated a significant improvement in the CFQ-R, with a treatment difference in mean change from baseline of 9.7 points in the respiratory domain (on a scale of 100) compared to placebo (p less than 0.001) following a 28-day treatment course with 75 mg aztreonam lysine for inhalation or volume-matched placebo administered three times daily by the PARI eFlow(R) Electronic Nebulizer. Aztreonam lysine-treated patients also experienced significant improvements at Day 28 in respiratory function, as measured by relative improvement of FEV1, with a treatment difference in mean change from baseline of 10.3 percent versus placebo (p less than 0.001). Full study results will be submitted for presentation at an upcoming scientific meeting.

The most common treatment-emergent adverse events in this study were cough, productive cough, nasal congestion, sore throat and dyspnea (shortness of breath). The incidences of these events were not significantly different between the placebo and the aztreonam lysine groups.

"The FDA, Cystic Fibrosis Foundation and medical community have identified PROs as important endpoints in clinical trials for CF and a variety of other diseases," said A. Bruce Montgomery, MD, Senior Vice President, Head of Respiratory Therapeutics, Gilead Sciences. "AIR-CF1 is the first Phase II
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