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.
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