FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company will initiate an expanded access program beginning August 1, 2007 to provide its investigational therapy, aztreonam lysine for inhalation, to patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (P. aeruginosa) infection who have limited treatment options and are at risk for disease progression. The expanded access program for aztreonam lysine for inhalation will be open to participating treatment centers in the United States. Based on results from two pivotal Phase III clinical studies, Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aztreonam lysine by the end of 2007.
