Positive Data on Forest Candidate - Analyst Blog
April 18 2013 - 12:00PM
Zacks
Forest Laboratories, Inc. (FRX) and Almirall,
S.A. recently announced positive top-line data on their chronic
obstructive pulmonary disease (COPD) fixed dose combination
candidate, aclidinium bromide plus formoterol fumarate.
Two fixed dose combinations – aclidinium/formoterol (400/6mcg
and 400/12mcg given twice a day) – were evaluated in the six-month
pivotal phase III study. Results showed that both combinations
achieved a statistically significant improvement in the co-primary
endpoints compared to formoterol as well as placebo. The
combination showed an improvement in lung function.
Forest Labs said that both doses were found to be well-tolerated
with common adverse events including nasopharyngitis and back pain.
Aclidinium/formoterol was administered using Almirall’s inhaler
Genuair (US trade name: Pressair).
Forest Labs and Almirall are currently waiting for results form
a second pivotal phase III study, which should be out shortly.
Positive results from this study would allow Forest Labs and
Almirall to go ahead and seek marketing approval for the
combination treatment in the US and the EU.
We note that the 400mcg formulation of aclidinium bromide is
already approved under the trade name Tudorza (US trade name; EU
trade name: Eklira). Tudorza, which gained Food and Drug
Administration (FDA) approval in the US in Jul 2012, was launched
in Dec 2012. Tudorza is approved for the long-term maintenance
treatment of bronchospasm associated with COPD including chronic
bronchitis and emphysema. Tudorza sales came in at $12.2 million in
the Dec 2012 quarter.
The successful development and approval of the fixed dose
combination would help strengthen Forest Labs’ position in the COPD
market. According to the World Health Organization (WHO), about 64
million people across the world suffer from COPD.
Forest Labs currently holds a Zacks Rank #3 (Hold). Forest Labs
is facing tough times with Lexapro losing exclusivity. Namenda’s
performance has also been disappointing. Moreover, the performance
of new products, especially Teflaro, has been below expectations.
Meanwhile, Namenda will face generic competition in early 2015
putting another $1+ billion at risk. Forest Labs has, however, made
significant progress with its pipeline and should be on the lookout
for additional deals in the next couple of years.
Companies that look better-positioned include
UCB (UCBJF), QLT Inc. (QLTI) and
Catalyst Pharmaceuticals Partners Inc. (CPRX). All
three are Zacks Rank #1 (Strong Buy) stocks.
CATALYST PHARMA (CPRX): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
QLT INC (QLTI): Free Stock Analysis Report
UCB SA (UCBJF): Get Free Report
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