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Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
Date:5/20/2008

ll tolerated at all doses, and the majority of AEs were considered mild. The most commonly reported adverse events were coughing (n=2) and dysphagia (n=1). One serious AE (hospitalization due to severe diarrhea) occurred after the last dose of 800 mcg and was judged by the investigator as unrelated to treatment. There were no clinically relevant changes in laboratory parameters, vital signs or ECG.

"These clinical data suggest that aclidinium may be a valuable treatment option for patients suffering from COPD," said Dr. Jorge Gallardo, Chairman and Chief Executive Officer of Almirall. "We remain committed to our partnership with Forest Laboratories to jointly develop aclidinium."

Results of pre-clinical animal and in vitro studies announced at the meeting showed that aclidinium exhibited low potential for cardiovascular effects and was broken down in the plasma within 1.8 to 38 minutes, across the models studied. In addition, aclidinium had a potent and long-lasting effect on preventing bronchoconstriction in both the human bronchi and several animal models assessed.

Abstracts from ATS 2008 will be available upon request.

About Aclidinium Bromide

Aclidinium bromide is a novel, inhaled anticholinergic bronchodilator that is currently in phase III clinical development as a once-daily maintenance treatment for COPD. Almirall licensed US rights to aclidinium to Forest Laboratories. The companies are jointly involved in the development of the compound.

About COPD

COPD is a preventable and treatable lung disease characterized by chronic airflow limitation that interferes with normal breathing and is not fully reversible. Globally, an estimated 80 million people have moderate to severe COPD. In excess of 3 million people died of the condition in 2005, accounting for 5% of all deaths worldwide.

About Forest Laboratories and Its Products

Forest Laboratories is a U.S.-based pharmaceutical company dedicated to iden
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SOURCE Forest Laboratories, Inc.
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