FRX Forest Road Acquisition Corp

Forest Laboratories, Inc. (FRX) and Almirall recently announced that they will be presenting additional data on their chronic obstructive pulmonary disease (COPD) candidate, aclidinium bromide, from the phase III ATTAIN study. Data will be presented at the upcoming annual meeting of the American Thoracic Society.

Forest Labs and Almirall had presented positive results on aclidinium bromide from ATTAIN earlier this year. The study compared the safety and efficacy of aclidinium bromide (200μg and 400μg dosed twice daily) with placebo.

Top-Line Results Presented in Jan 2011

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.

Regulatory Filings in Mid-2011

Forest Labs and Almirall are on track to file for regulatory approval of aclidinium (as a monotherapy) in mid-2011. While US rights for aclidinium have been in-licensed by Forest Labs from Almirall, ex-US rights remain with Almirall.

Aclidinum’s approval would be a major boost for Forest Labs. The COPD market represents huge commercial potential – according to the World Health Organization (WHO), about 210 million people suffer from COPD across the world. We note that Forest Labs received US Food and Drug Administration (FDA) approval for another COPD candidate, Daliresp, in March 2011.

Neutral on Forest Labs

We currently have a Neutral recommendation on Forest Labs, supported by a Zacks #3 Rank (short-term Hold rating). With Lexapro losing patent protection in March 2012, roughly half the company’s top-line will be exposed to generic competition.

Namenda will face generic competition in early 2015 -- this would put another $1+ billion at risk. Given the situation, we believe that Forest Labs will continue to seek in-licensing and acquisition activities to grow its pipeline.

 
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