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Gilead Announces Presentation of Positive Phase III Data on,Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis

SEATTLE--(BUSINESS WIRE)--Apr 19, 2007 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced detailed results of its Phase III AIR-CF2 study evaluating aztreonam lysine for inhalation, an antibiotic, in patients with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa). In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous (IV) antibiotics versus placebo. All patients received an initial 28 days of treatment with tobramycin inhalation solution prior to receiving study drug. Aztreonam lysine for inhalation was well tolerated and patients also experienced significant improvements in pulmonary function and respiratory symptoms. The data were presented by Karen S. McCoy, MD, Chief of the Division of Pediatric Pulmonology and Associate Professor of Pediatrics at The Ohio State University College of Medicine and Chief of the Section of Pulmonology at Columbus Children's Hospital, at this year's Cystic Fibrosis Therapeutics Development Network conference in Seattle, Washington. Topline results from this study were previously announced on December 19, 2006.

AIR-CF2 was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with CF who have pulmonary P. aeruginosa. Patients were randomized to receive 28 days of treatment with 75 mg of aztreonam lysine or volume-matched placebo each administered twice (BID) or three times (TID) daily by the eFlow(R) Electronic Nebulizer. Patients were followed for an overall study period of 126 days, with 56 days of observation after receiving aztreonam lysine for inhalation therapy or placebo.

Two hundred and forty-six patients were enrolled in the study and of those 211 were randomized to receive a
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