Positive Data on Forest Combo Drug - Analyst Blog
May 07 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 (LAMA) and formoterol fumarate
(LABA).
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 named AUGMENT COPD. Results showed that
both combinations achieved a statistically significant improvement
in the co-primary endpoints compared to placebo.
Forest Labs said that both doses were found to be well-tolerated
with common adverse events including cough, headache, urinary tract
infection and back pain among others. Aclidinium/formoterol was
administered using Almirall’s inhaler Genuair (US trade name:
Pressair)
The results presented from this study were consistent with
results presented last month from another pivotal phase III study -
ACLIFORM/COPD.
With both phase III studies generating positive results, Forest
Labs intends to file for US and EU approval in the fourth quarter
of 2013.
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 $23 million in
fiscal 2013. Forest Labs expects Tudorza sales of $90 million in
fiscal 2014.
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. 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 Catalyst
Pharmaceuticals Partners Inc. (CPRX), Elan
Corporation (ELN) and Cubist
Pharmaceuticals (CBST). While Catalyst Pharma is a Zacks
Rank #1 (Strong Buy) stock, Cubist Pharma and Elan are Zacks Rank
#2 (Buy) stocks.
CUBIST PHARM (CBST): Free Stock Analysis Report
CATALYST PHARMA (CPRX): Free Stock Analysis Report
ELAN CP PLC ADR (ELN): Free Stock Analysis Report
FOREST LABS A (FRX): Free Stock Analysis Report
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