Forest Laboratories, Inc.
) 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
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
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
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.
). 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
CATALYST PHARMA (CPRX): Free Stock Analysis
ELAN CP PLC ADR (ELN): Free Stock Analysis
FOREST LABS A (FRX): Free Stock Analysis
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