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Gilead to expand access to experimental CF drug

Mon Jul 9, 2007 5:08pm EDT

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LOS ANGELES, July 9 (Reuters) - Gilead Sciences Inc(GILD.O) said on Monday it planned to launch a program that would give seriously ill cystic fibrosis (CF) patients with Pseudomonas aeruginosa infection access to its experimental inhalable antibiotic aztreonam lysine.

The company's expanded access program, scheduled to begin Aug. 1, will be available through participating treatment centers in the United States to people who have limited treatment options and are at risk for disease progression.

Gilead expects to submit a New Drug Application to the U.S. Food and Drug Administration for aztreonam lysine by the end of 2007.

Aztreonam lysine for inhalation is an investigational formulation of the antibiotic aztreonam, which is currently available and given by injection.

Expanded access programs make investigational drugs available during the later stages of clinical development for the treatment of serious or life-threatening diseases.

((Reporting by Lisa Baertlein, editing by Toni Reinhold; Reuters Messaging: lisa.baertlein.reuters.com@reuters.net; E-mail: lisa.baertlein.reuters.com@reuters.net; Tel +1 213 955 6742)) Keywords: GILEAD CYSTICFIBROSIS

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