Almirall says it is putting on hold the European filing of a once-daily regimen for its investigational chronic obstructive lung disease drug Eklira to concentrate on the twice-daily dosing for the drug.

The Spanish drugmaker says the move is based primarily on the recent positive top-line results from the first Phase III study of Eklira (aclidinium bromide), investigating the twice-daily (BID) administration of the drug in COPD patients. Given this data, and promising findings from a Phase II study, Almirall “will give full priority to the development and filing of the BID dosing of Eklira”.

Jorge Gallardo, chief executive of Almirall, said “this strategic decision has been taken following discussions with European regulatory experts and key opinion leaders from which it became clear that BID dosing is likely to provide a superior benefit for COPD patients”. He added that “focusing on BID also has the benefit to increase the likelihood of product approval and long-term value for shareholders” and “strengthens the opportunity for the Eklira franchise (both monotherapy and in combination with formoterol) to generate worldwide blockbuster potential”.

Two additional Phase III studies are currently underway and the results will be available between the second half of 2010 and early 2011. Also two Phase IIb trials of aclidinium and formoterol are ongoing and top-line results are expected at the end of the year.