Almirall rises on positive Ph III results for aclidinium in COPD, partnered with Forest; Likely FDA 'no' to Forests' Bystolic in CHF

Spain's largest drugmaker Almirall saw its share price rise 3.9% to 9.51 euros in morning trading yesterday when - together with US licensee Forest Laboratories - it announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing their developmental chronic obstructive pulmonary disease (COPD) drug aclidinium (trade name Eklira) 200mcg and 400mcg BID versus placebo.

Aclidinium bromide produced statistically significant (p<0.0001) changes from baseline in morning pre-dose (trough) fev1 versus placebo at week 12, which was the primary endpoint for the study. changes from baseline values in morning trough fev1 compared to placebo were 86ml and 124 ml for the 200mcg and 400mcg bid groups, respectively. this is the first of three pivotal phase iii studies investigating the bid administration of aclidinium in copd patients. >

This is good news for the companies after, in the spring of last year, Forest and Almirall said that a planned New Drug Application filing for their new COPD drug would be delayed for an uncertain amount of time after the US Food and Drug Administration made it clear that they will need to conduct additional studies on aclidinium.