Almirall and Forest report preliminary topline results from the ACCORD COPD II Phase III study of aclidinium bromide in Chronic Obstructive Pulmonary Disease (COPD)
Barcelona and New York, October 29, 2010.- Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE: FRX) today announced top-line results from ACCORD COPD II, a 12-week Phase III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD. This is the second of three double-blind placebo-controlled pivotal Phase III studies investigating twice-daily (BID) aclidinium bromide 200ug and 400ug. The improvement from baseline in FEV1, the primary endpoint, was statistically significant in the 200ug (p=0.019) and 400ug (p=0.001) BID dose groups, however, for the expected therapeutic dose, 400ug, the magnitude of effect compared to placebo, 72 mL, was less than that observed in three other studies; i) the similarly designed ACCORD COPD I Phase III trial reported in January this year, ii) a previously reported 15-day Phase II trial comparing aclidinium 400ug BID to placebo or tiotropium 18ug once daily, and iii) a recently completed 7-day Phase II trial comparing aclidinium 400ug BID to placebo or formoterol. Across these other trials the difference in FEV1 from baseline ranged from 124 mL to 186 mL.
Further analyses of the results of the present trial are ongoing. Aclidinium was well tolerated in this study with a profile that was consistent with prior studies. In addition, a third double-blind placebo controlled trial (ATTAIN) of the 400ug BID aclidinium dose of six months duration assessing efficacy and safety in patients with COPD is currently underway with results from that study expected to be available in 1Q 2011. The ATTAIN study, if positive, along with the previously reported ACCORD COPD I Phase III trial of aclidinium BID, will serve as the core for the monotherapy US NDA and EU filings anticipated in mid-2011.
"We remain confident that the ongoing Phase III ATTAIN trial will confirm a clinical effect of aclidinium BID similar to that as reported in January of this year for the ACCORD COPD I trial and the Phase II comparison studies" said Lawrence S. Olanoff, President and Chief Operating Officer of Forest Laboratories.
"We believe aclidinium bromide has the potential to be an important treatment option for the millions of COPD patients suffering with this debilitating disease" said Per-Olof Andersson, Executive Director Research and Development at Almirall.
About the studies:
Phase III ACCORD COPD II
This randomized, double-blind, placebo-controlled study assessed the efficacy, safety, and tolerability of two doses of aclidinium bromide compared with placebo for 12 weeks. The study was conducted in North America and randomized a total of 544 patients. Mean baseline FEV1 at randomization ranged from 1,262 to 1,447mL.
The primary endpoint, which was significant (p<0.02) at both aclidinium doses, assessed morning pre-dose (trough) FEV1 at week 12.
Phase II Study Comparison to Formoterol
This randomized, double-blind, double-dummy 5-period 7-day crossover study assessed the efficacy of three doses of aclidinium bromide (100ug, 200ug or 400ug) BID compared to formoterol 12ug BID and placebo in 79 patients. The primary endpoint, which was significant for all active treatments versus placebo (p<0.05), was change from baseline in normalized FEV1 area under the curve over the 12-hour period following morning dosing at Day 7.
About aclidinium bromide and the Genuair® inhaler
Aclidinium bromide is a novel, long-acting inhaled investigational anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories, Inc. licensed US rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.
Aclidinium bromide is administered to patients using a novel, investigational, state-of-the-art multidose dry powder inhaler (MDPI), Genuair®. The Genuair® inhaler was designed with a feedback system, which through a 'coloured control window' and an audible click helps confirm that the patient has inhaled correctly. It contains multiple doses of aclidinium, includes a visible dose level indicator and also incorporates safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler. Genuair® is a trademark owned by Almirall, S.A.
The World Health Organisation (WHO) has described COPD as a global epidemic; an estimated 210 million people have COPD worldwide and 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.
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 a chronic cough. Daily activities, such as walking up a short flight of stairs or carrying a suitcase, can become very difficult as the condition gradually worsens. There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function, reduce symptoms and control exacerbations.
Almirall, an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing.
The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions.
Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.
About Forest Laboratories
Forest Laboratories, Inc. (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, 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 Report on Form 10-Q, and any subsequent SEC filings.
SOURCE: Almirall, S.A. and Forest Laboratories, Inc.
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