Forest Laboratories and Almirall Provide Update on the Fixed Dose Combination of Aclidinium and Formoterol in the U.S.
April 09 2014 - 3:17AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC)
today announced that they have recently received feedback from the
U.S. Food and Drug Administration (FDA) regarding the fixed dose
combination of aclidinium and formoterol. Although no new issues
have arisen, further discussion is needed with the Agency in order
to address questions related to CMC (Chemistry, Manufacturing and
Control) and a Type C meeting with the FDA is going to be
requested, likely to be held during Q3 this year. Forest and
Almirall believe that the fixed dose combination of aclidinium and
formoterol can be an important therapy for U.S. COPD (Chronic
Obstructive Pulmonary Disease) patients.
About
Aclidinium/formoterol
Forest and Almirall completed two pivotal phase III clinical
trials for aclidinium/formoterol in the spring of 2013. 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 through our own R&D efforts, which exceeded
18% on sales in 2013, together with external partnerships, licenses
and collaborations. 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 3000 employees in 23 countries, Almirall generated total
revenues of 825 million euros in 2013.
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) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in the following therapeutic areas:
central nervous system, cardiovascular, gastrointestinal,
respiratory, anti-infective, and cystic fibrosis. Our strategy of
acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers
and acquisitions allows us to take advantage of attractive
late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. 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.
Investor Relations:AlmirallJordi Molina, +34 93 291 30
87jordi.molina@almirall.comorMedia Relations:Cohn &
WolfeAdriana Ibargüen, +34 91 531 42
67adriana.ibarguen@cohnwolfe.comorMarta Velasco, +34 91 531 50
97marta.velasco@cohnwolfe.comMobile: +34 636 43 83 36orForest
LaboratoriesFrank J. Murdolo, 1-212-224-6713Vice President -
Investor Relationsmedia.relations@frx.comorAmanda Kaufman,
1-646-231-7316Media Relationsamanda.kaufman@frx.com
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