Forest Seeks FDA Nod for COPD Drug - Analyst Blog
July 01 2011 - 10:15AM
Zacks
Forest Laboratories, Inc. (FRX) 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.
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