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

nam lysine for inhalation in people with CF. Each patient's participation in the study will last up to 18 months. Patients will receive treatment with 75 mg of aztreonam lysine for inhalation with the same regimen they received in AIR-CF1 or AIR-CF2 (BID or TID daily).

Gilead anticipates that data from AIR-CF1 will be available in the second quarter of 2007 and plans 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.

About Aztreonam Lysine for Inhalation

Aztreonam lysine for inhalation is an antibiotic candidate currently being studied in Phase III clinical trials as a treatment for people with CF who have pulmonary P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is a FDA-approved agent for intravenous administration. Aztreonam lysine for inhalation is a proprietary inhaled formulation of aztreonam and has been designated with orphan drug status in the United States and Europe.

About PARI and the eFlow Electronic Nebulizer

Aztreonam lysine is delivered through a novel inhalation device, the eFlow Electronic Nebulizer, developed by PARI Pharma GmbH. The eFlow is an electronic, portable nebulizer that enables efficient aerosolization of liquid medications via a vibrating, perforated membrane.

PARI is dedicated to advancing aerosol therapies through innovative device and formulation technologies. PARI develops and manufactures aerosol delivery systems for patients with lung diseases, and was a partner in developing the aztreonam lysine formulation.

About Cystic Fibrosis

Today, more than 30,000 people in the United States have CF. CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predispo
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