NEW YORK, March 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. today announced after consultation with the U.S. Food and Drug Administration (FDA), that additional clinical studies of aclidinium bromide for the treatment of chronic obstructive pulmonary disease (COPD) will be conducted to provide further support for the selected regimens, including higher and/or more frequent doses. This decision follows a meeting with the FDA to review the previously reported ACCLAIM/COPD I and II studies. The Companies originally anticipated filing a New Drug Application (NDA) in the fourth quarter of 2009 or the first quarter of 2010, pending FDA feedback. Timelines for the development of the additional clinical studies and the future filing date of an NDA, including the ACCLAIM studies, are being determined.
About COPD
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.
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(1). There are significant unmet needs in the treatment of COPD including limited therapeutic options to improve lung function and control exacerbations.
About aclidinium bromide and Genuair(R)
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. Forest Laboratories 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, state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R)(2). Genuair(R) was designed with an intuitive feedback system, which through a ‘colored control window’ and an audible click indicates that the patient has inhaled correctly. The Genuair(R) inhaler contains multiple doses with a visible dose level indicator and also incorporates significant safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
About Forest Laboratories
Forest Laboratories (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.
About Almirall
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 dermatology in general.
Almirall is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.
For further information please visit the website at: www.almirall.com
(1) WHO fact sheet 315. May 2008. Chronic obstructive pulmonary Disease (COPD).
(2) Genuair is a registered trademark of Laboratorios Almirall, S.A. It is the proposed registered trademark for the Multiple-Dose Dry Powder Inhaler (MDPI) and is pending regulatory approval.
SOURCE Forest Laboratories, Inc.
