Almirall, Forest COPD drug misses goal in PhIII study

Spain's Laboratorios Almirall fell the most in two years after results from a study of aclidinium bromide, an investigative bronchodilator, showed a smaller benefit for patients what had been observed in previous studies, Bloomberg reports. Almirall is partnered with Forest Laboratories on the product.

The ACCORD COPD II study in 544 patients with moderate to severe COPD is the second of three double-blind, placebo-controlled Phase III studies investigating twice-daily aclidinium bromide, 200 and 400 ug. The drug did seem to help patients; however, for the expected therapeutic dose, 400 ug, the magnitude of effect compared with placebo was less than that observed in three other studies.

If approved, the product would compete with  Boehringer Ingelheim's Spiriva. The disappointing results follow a similar announcement in September 2008 that Almirall's drug hadn't matched the effect shown in previous trials, says Francisco Salvador, a Madrid-based strategist at Iberian Equities, as quoted by Bloomberg.

The companies will continue to analyze the results. In addition, a third double-blind placebo controlled trial (ATTAIN) is under way, with results expected in Q1 2011. If they obtain positive results from the study, it--along with the previously reported ACCORD COPD I Phase III trial--will serve as the core for the U.S. and EU regulatory filings anticipated in mid-2011.

- read the Almirall statement
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