Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Developme...( NEW YORK March 6 /- Forest Laborato...),Health

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.

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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
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