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Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Date:9/2/2008

NEW YORK, Sept. 3 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Laboratorios Almirall, S.A. today announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructive pulmonary disease (COPD). In both the ACCLAIM/COPD I&II (AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to Severe COPD Patients) studies, once-daily aclidinium bromide showed a statistically significant difference vs. placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in moderate to severe COPD patients.

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In both studies aclidinium therapy demonstrated a significant difference vs placebo in trough FEV1 at 12 weeks (p-value <0.001) and 28 weeks (p-value <0.001). The effect of aclidinium compared to placebo in trough FEV1 was maintained over one year (p-value <0.001). The improvement in the trough FEV1, at weeks 12 and 28, of aclidinium arms compared to placebo was in the range of 60 to 70 mL in both trials. The change from baseline in peak FEV1 observed after dosing aclidinium compared to placebo at 12 and 28 weeks was between 154 and 177 mL (p-value <0.0001), with a median time to peak of 2 hours.

"The studies confirm the bronchodilatory effect of aclidinium at the dose tested, although the magnitude was lower than seen in previous studies. We are working actively with Forest and members of the ACCLAIM/COPD Steering Committee to fully understand these findings to determine the best way forward including the extent of the
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SOURCE Forest Laboratories, Inc.
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