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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

I clinical trial in CF to use a PRO as its primary endpoint. We appreciate the collaboration with regulatory authorities and with the CF research community in designing this study and we thank the patients and investigators for their participation. Based on the successful completion of our second pivotal study, we plan to submit a New Drug Application (NDA) for aztreonam lysine for inhalation for the treatment of people with CF who have pulmonary P. aeruginosa to the U.S. FDA in the second half of 2007."

Data from this analysis have not been reviewed by the U.S. Food and Drug Administration (FDA). Aztreonam lysine is an investigational compound and has not yet been determined safe or efficacious in humans.

About AIR-CF Phase III Clinical Program

AIR-CF1 is one of three Phase III studies in the AIR-CF clinical program. The program, which also includes AIR-CF2 and AIR-CF3, is designed to determine the safety and efficacy of aztreonam lysine for inhalation for treatment of people with CF who have pulmonary P. aeruginosa.

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 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. Positive results from this study were presented at the Cystic Fibrosis Therapeutics Development Network conference in Seattle, Washington on April 19, 2007.

AIR-CF3 is an open-label, multi-center study of patients who participated in the AIR-CF1 or AIR-CF2 studies. The
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