Almirall and Forest Laboratories Announce Positive Phase III Study Results
for Aclidinium and Formoterol Combination in COPD
*Aclidinium / Formoterol Fixed Dose Combinations Twice Daily Show
Statistically Significant Improvements in the Two Co-Primary Endpoints in
the First Pivotal COPD Study
*a Second Pivotal Phase III Study is Still Ongoing, Results Expected in
BARCELONA & NEW YORK -- April 16, 2013
Almirall, S.A. (ALM:MC) and Forest Laboratories, Inc. (NYSE:FRX) today
announced positive topline results from a six month pivotal phase III clinical
trial evaluating the efficacy and safety of fixed dose combinations of
aclidinium bromide, (LAMA) and formoterol fumarate (LABA) delivered by
Almirall’s inhaler Genuair^® (Pressair™ in the USA).
Both combinations of aclidinium/formoterol (400/6mcg and 400/12mcg given twice
a day) demonstrated statistically significant improvements in the co-primary
endpoints of change from baseline in morning predose trough FEV1 versus
formoterol 12mcg and in FEV1 at 1 hour post-dose versus aclidinium 400mcg at
week 24 (p<0.01 and p≤0.0001, respectively). In addition, both combinations of
aclidinium/formoterol (400/6mcg and 400/12mcg) provided statistically
significant improvements versus placebo in the above two variables (both
Both fixed-dose combination treatment arms were well tolerated in this study.
The most common adverse events (greater than or equal to 3% and reported more
frequently with aclidinium/formoterol than placebo) were nasopharyngitis (7.9%
for 400/6mcg and 7.8% for 400/12mcg fixed-dose combinations and 7.2% for
placebo) and back pain (3.4% for 400/6mcg and 4.7% for 400/12mcg fixed-dose
combinations and 4.6% for the placebo group).
Results from a second pivotal Phase III clinical study are expected in the
coming weeks. If the second clinical trial is successful those results,
combined with the positive results of this study, will support our intention
to file an NDA with the FDA and an MAA to the EMA.
“We expect this novel combination of aclidinium/formoterol to offer patients a
new option in COPD treatment. In addition to the improved efficacy shown in
this study, the safety profile was comparable to placebo”, commented Bertil
Lindmark, Chief Scientific Officer at Almirall. “Indeed, these positive
results confirm Almirall’s potential to build an innovative worldwide
respiratory franchise around our Genuair^® device and aclidinium bromide
“By successfully achieving the primary endpoints in this pivotal trial, we
have demonstrated the superior improvement in lung function that can be
achieved by combining two proven bronchodilators with complementary modes of
action,” said Dr. Marco Taglietti, President of Forest Research Institute.
“Aclidinium/formoterol has the potential to further expand the success of the
Forest respiratory franchise which includes Tudorza^TM Pressair^TM (aclidinium
bromide 400mcg), as a treatment option for COPD patients who could benefit
from additional bronchodilation”.
About the Phase III Study
ACLIFORM/COPD (ACLIdinium/FORMoterol fumarate combination for Investigative
use in the treatment of moderate to severe COPD) was a 24-week randomized
double-blind trial evaluating the 400/6mcg and 400/12mcg fixed dose
combinations of aclidinium bromide/formoterol fumarate compared with
aclidinium bromide 400mcg, formoterol fumarate 12mcg and placebo administered
BID through the Genuair^®/Pressair™ inhalers in 1729 patients with moderate to
severe COPD, in 22 countries including Europe, Korea and South Africa.
For the co-primary efficacy endpoint of change from baseline in morning
pre-dose trough FEV1 at week 24, aclidinium/formoterol 400/6mcg and 400/12 mcg
demonstrated statistically significant improvements versus formoterol 12mcg
(53mL and 85mL, respectively) and placebo (111mL and 143mL, respectively). For
the second co-primary endpoint of change from baseline in FEV1 at 1 hour
post-dose versus aclidinium 400mcg, aclidinium/formoterol 400/6mcg and 400/12
mcg demonstrated statistically significant improvements versus aclidinium
400mcg (69mL and 125mL, respectively) and placebo (244mL and 299mL,
The full results of this study will be presented at future scientific
Aclidinium bromide/formoterol fumarate (400/6mcg and 400/12mcg) are
investigational fixed dose combinations 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^TM/Eklira^®) and formoterol fumarate are approved for the
maintenance treatment of COPD in the United States and Europe.
Aclidinium/formoterol was administered using a multiple-dose dry powder
inhaler, Pressair^™ (outside of the United States the inhaler is marketed as
Genuair^®), which delivers 60 doses of aclidinium bromide/formoterol fumarate
powder for inhalation. The Pressair inhaler has a colored control window which
confirms successful inhalation of the full dose and a dose indicator to let
patients know approximately how many doses remain in the inhaler. The
Pressair^TM / Genuair^® inhaler is approved in the United States and Europe
for the administration of Tudorza^TM/ Eklira^®.
Aclidinium/formoterol combines two effective bronchodilators with
complementary mechanisms of action and is being evaluated as a potential
treatment for COPD patients who could benefit from two bronchodilators
administered in a single multi-dose inhaler.
COPD, or chronic obstructive pulmonary disease, is a common, progressive, and
debilitating lung disease characterized by persistent airflow limitation that
makes it hard to breathe. The World Health Organization (WHO) has described
COPD as a global epidemic; an estimated 64 million people have COPD worldwide.
More than 3 million people died of the condition in 2005, which is equal to 5%
of all deaths globally that year. Total deaths from COPD are projected to
increase by more than 30% in the next 10 years without interventions to cut
risks, particularly exposure to tobacco smoke. WHO predicts that COPD will
become the third leading cause of death worldwide by 2030^1. COPD is already
the third leading cause of death in the U.S.
In patients with COPD the airways in the lungs typically lose their
elasticity, produce excess mucus and become thick and inflamed, limiting the
passage of air. The most common symptoms of COPD are breathlessness (or a
"need for air"), abnormal sputum (a mix of saliva and mucus in the airway),
and chronic cough. As the condition worsens and breathlessness increases,
daily activities, such as walking up a short flight of stairs or carrying a
suitcase, can become very difficult. New therapies to treat this debilitating
disease may be of value.
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 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
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.
^1 WHO Burden of COPD
Bianca Daneshfar-Nia, +44 20 76113510
Jordi Molina, +34 93 291 30 87
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
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