Aptalis reports Phase III data for antibiotic in CF patients

Aptalis Pharma Inc. (Mont-Saint-Hilaire, Quebec) said twice-daily Aeroquin for 28 days met the primary endpoint in one Phase III trial and missed the primary endpoint in a second trial to treat chronic lung infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. In the open-label Phase III 209 trial, Aeroquin met the primary endpoint of non-inferiority to TOBI tobramycin from Novartis AG (NYSE:NVS; SIX:NOVN) in the relative change from baseline at day 28 in percent predicted forced expiratory volume in 1 second (FEV1). However, in the double-blind Phase III 207 trial, Aeroquin missed the primary endpoint of significantly improving time to first pulmonary exacerbation vs. placebo. ...