BARCELONA and NEW YORK, April 16,
2013 /PRNewswire/ --
- 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 coming weeks
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 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 both 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 p<0.0001).
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. The successful completion of the
second clinical trial combined with the positive results of this
study will support our intention to file an NDA to the FDA and a
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
(Eklira®/Bretaris®)".
"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 also at week 24, aclidinium/formoterol 400/6mcg and
400/12 mcg demonstrated statistically significant improvements
versus aclidinium 400mcg (69mL and 125mL, respectively) and placebo
(244mL and 299mL, respectively).
The full results of this study will be presented at future
scientific meetings.
About Aclidinium/Formoterol
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.
About COPD
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[i]. 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.
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 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 http://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
http://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.
i. WHO Burden of COPD