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Forest/Almirall Combo Drug Filing Delayed

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Forest Laboratories, Inc. (FRX) and Almirall, S.A. recently announced that they will not be submitting a new drug application (:NDA) for their chronic obstructive pulmonary disease (:COPD) fixed dose combination candidate, aclidinium bromide (:LAMA) and formoterol fumarate (:LABA) in the fourth quarter of 2013 as had been expected earlier.

Forest Labs said that the decision to delay the filing was based on a pre-NDA meeting with the FDA. Certain chemistry, manufacturing and control (CMC) specifications need to be resolved before the NDA can be filed. Forest Labs and Almirall are working with the FDA to determine the requirements. An update should be available once the companies gain more clarity on the information required by the agency. 

Earlier this year, Forest Labs and Almirall had presented encouraging data on two fixed dose combinations of aclidinium bromide and formoterol fumarate (400/6mcg and 400/12mcg given twice a day).

We note that the 400mcg formulation of aclidinium bromide is already approved under the trade name Tudorza (U.S. trade name; EU trade name: Eklira). Tudorza, which gained FDA approval in the U.S. 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.

The successful development and approval of the fixed dose combination would help strengthen Forest Labs’ position in the COPD market.

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.

Companies that currently look well-positioned include Questcor Pharmaceuticals, Inc. (QCOR), Anacor Pharmaceuticals, Inc. (ANAC) and Elan(ELN). While Questcor is a Zacks Rank #1 (Strong Buy) stock, Anacor and Elan carry a Zacks Rank #2 (Buy).

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