Almirall defies critics to progress COPD drug

Almirall, Spain's largest drugmaker, and US partner Forest Laboratories have confirmed that they plan to progress the development of aclidinium bromide, an inhaled anticholinergic medicine for the treatment of chronic obstructive pulmonary disease, despite the drug failing to match data produced by Boehringer Ingelheim's Spiriva (tiotropium; Marketletter September 15).

"Almirall is moving forward with aclidinium bromide. It continues to show great promise as a new treatment option in COPD, where there are considerable unmet medical needs," said Jorge Gallardo, chief executive. "We believe this medicine remains a substantial engine for long-term growth and value creation that can bring significant upside to our business. Negotiations with potential partners in Europe and Japan will continue," he added. The firm reiterated financial guidance for 2008 and also extended its predictions for 2009 with expected single digit growth in sales, R&D expense, EBITDA and normalized net income.

In the USA, Almirall and Forest plan to file a New Drug Application in late 2009/early 2010, pending Food and Drug Administration feedback. European filing is currently anticipated for 2011. The firms say they will further explore the utility of aclidinium at higher doses once daily and/or twice daily in new studies, claiming the adverse event profile from the ACCLAIM studies clearly suggests that higher doses will be well tolerated.