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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

primary objective of the study is to evaluate the safety of repeated exposure to aztreonam 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).

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 granted orphan drug designation in the United States and Europe.

About PARI Pharma and the eFlow Electronic Nebulizer

Aztreonam lysine for inhalation is delivered by a novel inhalation device, the eFlow Electronic Nebulizer, developed by PARI Pharma GmbH. eFlow is a quiet, portable nebulizer that enables efficient aerosolization of liquid medications via a vibrating, perforated membrane. PARI Pharma also contributed to the development and optimization of the drug formulation (aztreonam lysine for inhalation) for delivery via eFlow. Based on PARI's 100-year history working with aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.

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 predisposing patients to lung infections, which continually damage their lungs. Pulmonary in
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