Laboratorios Almirall has completed late-stage trials of its investigational compound for chronic obstructive pulmonary disease, aclidinuim bromide, a product that would transform the Spanish drugmaker if it receives approval.

Almirall and partner Forest Laboratories say its two Phase III ACCLAIM/COPD studies, which involved 1,647 COPD patients in 23 centres worldwide worldwide, has now closed. Preliminary, top-line results from both of the trials are expected to be available during the third quarter of 2008.

Late last year on a media trip to Almirall’s state-of-the-art R&D facilities near Barcelona, the firm’s executive director of R&D, Per Olof Andersson, told PharmaTimes World News that the company hopes to file aclidinium bromide in 2009. He hopes that the drug will then be in a position to challenge Boehringer Ingelheim's blockbuster Spiriva (tiotropium bromide), which is marketed by Pfizer, for the number one spot in COPD.

Much of Almirall’s enthusiasm about its product centres around the multidose dry powder inhaler, named Genuair, which will deliver the drug. At the aforementioned meeting, head of pharmaceutical development Carsten Niederlaender described the device as the “new gold standard" in inhalers.

Specifically, Genuair, which operates on the ‘one press and inhale’ concept, has been designed with a coloured control window that indicates the correct use. The inhaler contains 30 doses with a visible dose level indicator and Almirall said it incorporates “significant safety features” such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.