Almirall starts Ph III COPD trial; collaborates with BioFocus; and posts sales and earnings downturn

There was a batch of news from Spain’s largest drugmaker Almirall (ALM. MC), starting with the announcement that, with its US partner Forest Laboratories (NYSE: FRX), it has initiated a Phase III clinical program of the fixed dose combination (FDC) of aclidinium bromide and formoterol fumarate twice daily (BID) delivered in the Genuair inhaler, for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD).

The Phase III program involves approximately 3,500 patients with moderate to severe COPD and consists of two large pivotal studies -one conducted mainly in Europe and another in North America- evaluating the efficacy and safety of the FDC of aclidinium plus formoterol during 24 weeks, as well as a long-term safety study of 52 weeks which is also performed in North America. Protocols of these clinical trials have been designed to fulfil both EMA and FDA requirements.