Almirall and Forest Laboratories Announce Positive Results for the Second Phase III Study for Aclidinium and Formoterol

 Almirall and Forest Laboratories Announce Positive Results for the Second  Phase III Study for Aclidinium and Formoterol Combination in COPD        --  Aclidinium/formoterol demonstrates consistent, statistically         significant lung function improvement in the second pivotal         efficacy trial     --  Positive outcomes also were seen in TDI (breathlessness) and         SGRQ (quality of life) in this study     --  Regulatory filings in the United States Food and Drug         Administration (FDA) and European Medicines Agency (EMA) are         planned in Q4 2013  BARCELONA and NEW YORK, May 2, 2013 /CNW/ - Almirall, S.A. (ALM:MC) and Forest  Laboratories, Inc. (NYSE:FRX) today announced positive topline results from  AUGMENT/COPD, the second six-month pivotal phase III clinical trial evaluating  the efficacy and safety of investigational fixed dose combinations of  aclidinium bromide (LAMA) and formoterol fumarate (LABA) for the treatment of  Chronic Obstructive Pulmonary Disease (COPD), delivered in the  Pressair™inhaler (Genuair(®) outside the USA).  The 400/12mcg combination of aclidinium/formoterol given twice daily  demonstrated statistically significant improvements in change from baseline  for the co-primary endpoints of Forced Expiratory Volume (FEV1) at 1 hour  post-dose versus aclidinium 400mcg (p<0.0001), and morning predose trough FEV1  versus formoterol 12mcg at week 24 (p<0.05). The 400/6mcg combination  demonstrated statistically significant improvements in (FEV1) at 1 hour  post-dose versus aclidinium 400mcg (p<0.0001). For the change from baseline in  morning pre-dose trough FEV1, the 400/6mcg combination did not reach  significance versus formoterol 12mcg at week 24 (p>0.05).  Both combinations of aclidinium/formoterol (400/12mcg and 400/6mcg) provided  statistically significant improvements versus placebo in the above two  comparisons (both p<0.0001).  The positive results of the aclidinium/formoterol 400/12mcg combination in  this study are consistent with the statistically significant improvement in  lung function demonstrated by aclidinium/formoterol 400/12mcg in the  previously completed ACLIFORM/COPD Phase III study. In both studies, the  400/12mcg dose successfully met the required regulatory "Combination Rule" for  testing two or more drugs combined in a single dosage form.  Both studies included secondary endpoints. The endpoints analyzed to date were  change from baseline vs placebo at 24 weeks in TDI (Transitional Dyspnea  Index, which measures breathlessness) and in SGRQ (St. George's Respiratory  Questionnaire, a respiratory-specific disease-related quality of life  assessment). Positive outcomes were seen with the two combinations achieving  the MCID (Meaningful Clinical Important Difference) of a one point change  (p<0.0001) in TDI in both studies, and a four point change (p<0.0001) in SGRQ  in the AUGMENT/COPD study. Additional analyses, including those on pooled  data, will be presented at future scientific meetings.  Additionally, both aclidinium/formoterol treatment arms were well-tolerated in  this study. The most common adverse events (greater than or equal to 3% and  reported more frequently with either aclidinium/formoterol 400/12mcg or  aclidinium/formoterol 400/6mcg than placebo respectively) were: cough (5.1%,  3.9% and 3.6%); nasopharyngitis (4.8%, 5.1% and 3.6%); headache (4.8%, 4.2%  and 3.3%); urinary tract infection (4.5%, 2.1% and 3.0%); upper respiratory  tract infection (3.0%, 3.9% and 1.5%); back pain (3.0%, 1.5% and 2.7%);  diarrhea (2.7% 3.0% and 2.4%); nausea (1.5%, 4.5% and 1.2%); and dyspnea  (1.5%, 3.3% and 1.8%).  "We are very pleased with these results which confirm the efficacy and safety  profile of the novel combination of aclidinium/formoterol", commented Dr.  Bertil Lindmark, Chief Scientific Officer at Almirall. "The positive results  in breathlessness and quality of life measures combined with the patient  preferred Pressair/Genuair multidose device could place this new combination  as a treatment option for patients suffering from COPD. The successful  completion of both pivotal studies marks an important milestone towards  achieving an innovative global respiratory franchise around aclidinium and the  Almirall's Genuair inhaler."  "By successfully achieving the primary endpoints in these two pivotal trials,  we have demonstrated that aclidinium/formoterol, 400/12mcg, delivers  statistically significant improvement in lung function" said Dr. Marco  Taglietti, President of Forest Research Institute. "The success of this Phase  III program supports the potential of aclidinium/formoterol as a new treatment  option for COPD patients who could benefit from the enhanced bronchodilation  of two complementary, proven therapies."  Regulatory filings in the USA (FDA) and Europe (EMA) are planned in Q4 2013.  About AUGMENT/COPD Phase III Study  AUGMENT (Aclidinium/formoterol FUmurate Combination for InvestiGative use in  the TreatMENT of Moderate to Severe COPD) was a 24-week randomized  double-blind trial evaluating the 400/12mcg and 400/6mcg fixed dose  combinations of aclidinium bromide/formoterol fumarate compared with  aclidinium bromide 400mcg, formoterol fumarate 12mcg and placebo administered  BID through the Pressair inhaler (Genuair outside the USA) in 1,692 patients  with moderate to severe COPD in the USA, Australia and New Zealand.  Two co-primary endpoints, designed to take in account the different  contributions of the individual components in terms of efficacy, were  developed in consultation with FDA/EMA to meet the "Combination Rule" (i.e.,  showing superiority in FEV1 at week 24 of the fixed dose combination over  aclidinium at one hour post-dose and over formoterol at morning pre-dose  trough):    1. The first co-primary endpoint consisted of the comparison between      the fixed dose combinations of aclidinium/formoterol 400/12mcg and      400/6mcg versus aclidinium alone in change from baseline in FEV1      at 1 hour post-dose at week 24. The aclidinium/formoterol      400/12mcg and 400/6mcg achieved statistically significant      improvements compared with aclidinium 400mcg (108mL and 87mL,      respectively).    2. The second co-primary endpoint consisted of the comparison between      the fixed dose combinations of aclidinium/formoterol 400/12mcg and      400/6mcg versus formoterol alone in change from baseline in      morning pre-dose trough FEV1 at week 24. The aclidinium/formoterol      400/12mcg demonstrated statistically significant improvement      versus formoterol 12mcg (45mL). Aclidinium/formoterol 400/6mcg did      not demonstrate statistically significant improvement versus      formoterol 12mcg (26mL).  In this AUGMENT/COPD study, the aclidinium/formoterol 400/12mcg and 400/6mcg  also demonstrated superior efficacy in the secondary efficacy comparison for  each co-primary parameter as compared to placebo, achieving statistically  significant benefits 1-hour post-dose FEV1 (284mL and 263mL, respectively) and  in trough FEV1 (130mL and 111mL, respectively).  The positive results of the aclidinium/formoterol 400/12mcg combination in  this study are consistent with the statistically significant improvement in  lung function demonstrated by aclidinium/formoterol 400/12mcg in the  previously completed ACLIFORM/COPD Phase III study.  About the ACLIFORM/COPD 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 1,729 patients with  moderate to severe COPD, in 22 countries including Europe, Korea and South  Africa.  The full results of both studies will be presented at future scientific  meetings.  Aboutaclidinium/formoterol  Aclidinium bromide /formoterol fumarate (400/12mcg and 400/6mcg) 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™/Elkira(®) 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 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™/Genuair(®) inhaler is approved in the United States and Europe  for the administration of Tudorza™/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  Chronic Obstruction Pulminary Disease (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. 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 its 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 around  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 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.  Contact Almirall: Media information: Ketchum, Simon  Perry,simon.perry@ketchumpleon.com, Tel.: +44-20-76113562 ; Investor  Relations enquiries: Almirall, Jordi  Molina,jordi.molina@almirall.com ,  Tel.: +34-93-291-30-87 ; Contact Forest: Forest Laboratories, Inc.,  Frank J.  Murdolo, +1-212-224-6714, Vice President - Investor Relations,  media.relations@frx.com  SOURCE: Almirall, S.A. and Forest Laboratories, Inc.  To view this news release in HTML formatting, please use the following URL:  http://www.newswire.ca/en/releases/archive/May2013/02/c2785.html  CO: Almirall, S.A. and Forest Laboratories, Inc. ST: New York NI: MTC   -0- May/02/2013 08:13 GMT    
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