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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

fection with Gram-negative bacteria, particularly pulmonary P. aeruginosa, represents the single greatest cause of morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. For example, the safety and efficacy data from additional clinical studies may not warrant further development of this compound and initiating and completing clinical trials may take longer or cost more than expected. In addition, future discussions with the FDA may impact the amount of data needed and timelines for review, which may differ materially from Gilead's current projections. Further, the FDA may not approve aztreonam lysine for inhalation for the treatment of CF in the United States, and any marketing approval, if granted, may have significant limitations on its use. If and when regulatory approval is obtained, we will rely on PARI to distribute the device through specialty pharmacies or other distribution channels. If sufficient quantities of this device are not available at the time of a commercial launch or following such a launch, the commercial launch of aztreonam lysine for inhalation could be delayed, and the anticipated contribut
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