Almirall and Forest Laboratories Announce Positive Results of a Phase III Study for Aclidinium and Formoterol Combination in

Almirall and Forest Laboratories Announce Positive Results of a Phase III 
Study 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 coming weeks

BARCELONA AND NEW YORK, April 16, 2013 /CNW/ - 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 theForestrespiratory franchise,which includes 
Tudorza([)(TM])Pressair([)(TM])(aclidinium bromide 400mcg),as a treatment 
option for COPD patients who could benefit from additional bronchodilation".

AboutthePhase III Study

ACLIFORM/COPD(ACLIdinium/FORMoterol fumarate combination for Investigative 
use in the treatment of moderate to severeCOPD) 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 visithttp://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, visithttp://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

Almirall: Media information: Ketchum, Simon Perry,simon.perry@ketchum.com , 
Tel.: +44-20-76113562. Investor Relations enquiries: Almirall, Jordi  
Molina,jordi.molina@almirall.com , Tel.: +34-93-291-30-87. ContactForest: 
Forest Laboratories, Inc.,  Frank J. Murdolo, +1-212-224-6714, Vice President 
- Investor Relations, media.relations@frx.com .

SOURCE: Almirall

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CO: Almirall
ST: New York
NI: MTC 

-0- Apr/16/2013 13:38 GMT


 
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