Recently, Forest Laboratories (FRX) and Spain based Almirall announced positive phase III top-line results of Forest’s pipeline candidate aclidinium, a multi dose dry-powder inhaler for the treatment of chronic obstructive pulmonary disease (COPD).

It was observed that aclidinium met its primary end point – it produced statistically significant improvement from the baseline in morning pre-dose (trough) FEV1 versus placebo at week 12. While the drug has been developed by Almirall, Forest holds the US rights. Reported adverse events were similar across the study arms, which included COPD exacerbation, dyspnea, headache and nasopharyngitis.

Earlier, in 2008, Forest came out with mixed data on aclidinium from two phase III programs called ACCLAIM/COPD I & II. While safety and tolerability were excellent, efficacy data was disappointing. Although the primary endpoint was met, the improvement in FEV1 was lower than expected. In addition, though one of the trials could meet the secondary endpoint, the other trial failed, which caused a significant delay to the first moderate to severe exacerbation.

Overall, the efficacy data looks to be considerably inferior to Pfizer’s (PFE) Spiriva, which brought into question the marketability of the drug at the 200mcg/day dose. In March 2009, following a consultation with the US Food and Drug Administration (FDA), Forest decided to pursue additional testing at higher and/or more frequent doses.

Two additional phase III studies (one in North America and the other in Europe and the rest of the world) have been undertaken to assess the efficacy and safety of the drug in patients with COPD. Forest expects to come out with the results between the second half of 2010 and early 2011.

COPD refers to the obstruction of airways caused by chronic bronchitis. The disease affects about 14 million people in the U.S. and is the fourth most common cause of death. On approval, aclidinium could garner a portion of the highly competitive COPD market.

The lucrative COPD market led Forest Laboratories to enter into a deal with Switzerland-based Nycomed last year for the U.S. marketing rights of an experimental lung disease drug, Daxas. Forest is looking at alternatives to boost its pipeline to offset the loss of sales following the genericization of its biggest product, Lexapro, in the coming years. Given the scenario, Forest has acquired the rights to many products generally in mid- to late-stage development either through licensing deals or acquisitions.

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