Forest Seeks FDA Nod for COPD Drug

Forest Laboratories, Inc. (FRX - Analyst Report) and partner Almirall, S.A. recently announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for their chronic obstructive pulmonary disease (COPD) candidate, aclidinium bromide.

Aclidinium bromide is a long-acting inhaled antimuscarinic agent which has been developed for the treatment of COPD.

Top-Line Results Presented in Jan 2011

Forest Labs and Almirall had announced positive top-line data on aclidinium earlier this year. Results were presented from a pivotal phase III study (ATTAIN) that compared the safety and efficacy of aclidinium bromide (200μg and 400μg dosed twice daily) with placebo.

Results from the six month double-blind placebo-controlled ATTAIN study, which was conducted in 828 patients with moderate to severe COPD, showed that aclidinium achieved its primary as well as secondary endpoints. The COPD candidate was also found to be well tolerated. In late October 2010, Forest Labs and Almirall had presented positive top-line results on aclidinium from another phase III study - ACCORD COPD II.

The companies had also presented data from two phase IIb dose-ranging studies which compared fixed-dose combinations of aclidinium bromide + formoterol with aclidinium bromide alone, formoterol alone and placebo. The fixed dose combination achieved statistical significance compared to placebo in both studies. Forest Labs and Almirall intend to move the fixed dose combination into phase III studies in the second half of 2011.

Aclidinium’s approval would be a major boost for Forest Labs. While US rights for aclidinium have been in-licensed by Forest Labs from Almirall, ex-US rights remain with Almirall.

The COPD market represents huge commercial potential – according to the World Health Organization (WHO), about 64 million people suffer from COPD across the world. We note that Forest Labs received FDA approval for another COPD candidate, Daliresp, in March 2011.

Neutral on Forest Labs

We currently have a Neutral recommendation on Forest Labs. We are concerned about long-term growth at Forest Labs, especially from 2012 when Lexapro is exposed to generic competition. That puts a lot of pressure on the pipeline to come through.

Read the full analyst report on FRX