Forest Laboratories and Almirall Decide to Delay NDA Filing for Aclidinium/formoterol Combination
August 14 2013 - 4:02PM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A.
(ALM:MC) today announced that they will delay the planned Q4 2013
submission of a New Drug Application (NDA) for the combination of
aclidinium bromide, a long acting muscarinic antagonist and
formoterol fumarate, a long acting beta agonist, for the indication
of Chronic Obstructive Pulmonary Disease (COPD). This decision was
based on comments provided by the FDA at a recent pre-NDA
meeting.
The delay is related to resolving chemistry, manufacturing and
control (CMC) specifications associated with the combination
formulation. Forest and Almirall are working with the FDA regarding
the CMC related comments provided at the pre-NDA meeting to
determine the appropriate next steps, and expects to provide an
update when more information becomes available. The decision to
delay the NDA filing for the combination does not affect the
Tudorza® (alcidinium bromide) monotheraphy product.
About Aclidinium/formoterol
Forest and Almirall recently announced positive phase III
results from two pivotal clinical trials for aclidinium/formoterol.
The combination was administered twice a day and primary end points
were met which demonstrated statically significant improvements
versus placebo. In addition, aclidinium/formoterol was well
tolerated in both studies.
Aclidinium bromide /formoterol fumarate is an investigational
fixed dose combination of two approved long-acting bronchodilators
with different mechanisms of action and similar pharmocodynamic
profiles. Aclidinium bromide is an anticholinergic or long-acting
muscarinic antagonist (LAMA) that produces bronchodilation by
inhibiting the muscarinic M3 receptor in the airway smooth muscle.
Formoterol fumarate is a long-acting beta-agonist (LABA) that
stimulates the B2-receptors in the bronchial smooth muscle
resulting in bronchodilation.
Both aclidinium bromide (Tudorza®/ Eklira®) and formoterol
fumarate are approved for the maintenance treatment of COPD in the
United States and Europe.
About Almirall
Almirall is a pharmaceutical company committed to provide
valuable medicines from our own R&D, external partnerships,
licenses and collaborations. In 2012, Almirall invested over 23% of
its sales in R&D. Through seeking innovative medicines we aim
to become a relevant player in respiratory and dermatology diseases
with also a strong interest in gastroenterology and pain. With more
than 3,000 employees in 22 countries, Almirall generated total
revenues of 900 million euros in 2012.
The company was founded in 1943 and is headquartered in
Barcelona, Spain. The stock is traded in the Spanish stock exchange
(ticker: ALM). For more information please visit
www.almirall.com.
Tudorza™, Eklira®, Genuair® and Pressair™ are registered
trademarks of Almirall S.A.
About Forest Laboratories
Forest Laboratories' (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective, respiratory,
gastrointestinal and pain management medicine. Forest’s pipeline,
the most robust in its history, includes product candidates in all
stages of development across a wide range of therapeutic areas. The
Company is headquartered in New York, NY. To learn more, visit
www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories’ Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
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Investor/Media:AlmirallMedia
Information:KetchumAna Gonzalez, +34 660 673 173orInvestor
Relations:Jordi Molina, +34 93 291 30
87jordi.molina@almirall.comorForest
LaboratoriesFrank J. Murdolo, 1-212-224-6714Vice President -
Investor Relationsmedia.relations@frx.comorMedia:Sard
Verbinnen & CoHugh Burns / Lesley Bogdanow / Pamela
Blum1-212-687-8080
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