Forest and Almirall to Present Data from Phase III Studies of Aclidinium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
--Data to be presented at 2011 American Thoracic Society International Conference--
NEW YORK--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they are presenting additional data from ATTAIN, a pivotal Phase III study comparing the efficacy and safety of inhaled aclidinium bromide 200μg and 400μg twice daily (BID) versus placebo in patients with moderate to severe COPD, at ATS 2011, the annual International Conference of the American Thoracic Society taking place in Denver May 13-18, 2011. Positive top-line results from this six-month double-blind placebo-controlled study were first reported in January 2011.
Additional detail from the ATTAIN study, which was accepted as a late-breaker, will be presented in poster format on Sunday, May 15th (8:15 am - 4:30 pm, Session A45, D100, PW Jones).
Three other clinical posters on aclidinium will also be presented at ATS on Sunday, May 15th. These posters include additional analyses from the Phase III ACCORD COPD I study regarding the effects of aclidinium therapy on symptoms and quality of life, as well as the use of rescue medication (8:15 am - 4:30 pm, Session A45, D75, EM Kerwin; D97, A D'Urzo; D99, AF Gelb).
Results from one pharmacokinetic study with aclidinium BID (Sunday, May 15th at 8:15 am - 4:30 pm, Session A45, D98, K Lasseter) and five preclinical studies (Sunday, May 15th Session A45, D66, J Milara; and Monday, May 16th Session B69, L21, J Milara; L30, J Milara; L29, D Dominguez-Fandos; L23, E Ferrer) will also be presented.
About ATTAIN Phase III study
ATTAIN (Aclidinium To Treat Airway obstruction In COPD patieNts) was conducted in Europe and South Africa. It was a 24-week study, which assessed the long-term bronchodilator efficacy and safety of inhaled aclidinium bromide 200μg and 400μg, both administered BID, compared to placebo in 828 moderate to severe COPD patients (mean baseline FEV1= 1480mL). In addition, it assessed the benefits of aclidinium bromide 200μg and 400μg, compared to placebo in disease-related health status and COPD symptoms.
About aclidinium bromide and the Genuair® inhaler
Aclidinium bromide is a novel, long-acting inhaled 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. In clinical trials evaluating aclidinium for the treatment of COPD, the two most frequently reported side effects were headache and nasopharyngitis. 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 was administered to patients in the trials 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 'colored 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 registered trademark owned by Almirall, S.A.
The World Health Organization (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 and new therapies may be of value.
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), gastrointestinal disorders, 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.
For further information please visit: www.almirall.com.
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 and respiratory medicine. The Company'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.
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Annabel Gillett, +44 20 7611 3559
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Forest Laboratories, Inc.
Frank J. Murdolo, +1-212-224-6714
Vice President - Investor Relations
Posted: May 2011