Forest Laboratories, Inc.
) 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
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
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
Companies that currently look well-positioned include
Questcor Pharmaceuticals, Inc.
Anacor Pharmaceuticals, Inc.
). While Questcor is a Zacks Rank #1 (Strong Buy) stock, Anacor
and Elan carry a Zacks Rank #2 (Buy).
ANACOR PHARMACT (ANAC): Free Stock Analysis
ELAN CP PLC ADR (ELN): Free Stock Analysis
FOREST LABS A (FRX): Free Stock Analysis
QUESTCOR PHARMA (QCOR): Free Stock Analysis
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