Almirall, Forest report Phase III COPD data for combo

Almirall S.A. (Madrid:ALM) and partner Forest Laboratories Inc. (NYSE:FRX) said two fixed-dose combinations of aclidinium bromide and the long acting beta agonist (LABA) formoterol delivered via Almirall's Genuair inhaler met the co-primary endpoints in the Phase III ACLIFORM/COPD trial to treat chronic obstructive pulmonary disease (COPD). Both combinations improved morning pre-dose trough forced expiratory volume in 1 second (FEV1) from baseline to week 24 vs. formoterol (p<0.01 for both) and improved FEV1 from baseline at one hour post-dose vs. aclidinium bromide (p<=0.0001 for both). The double-blind, international trial enrolled 1,729 patients with moderate to severe COPD to receive placebo, formoterol, aclidinium bromide, twice-daily 400/6 ug aclidinium/formoterol or twice-daily 400/12 ug aclidinium/formoterol.

Data from a second Phase III trial of the combination are expected in "the coming weeks." Forest plans to submit an NDA to FDA in early 2014, while Almirall plans to submit an MAA to EMA by year end. Almirall was up EUR 0.02 to EUR 10.45 on Tuesday. ...