Positive top-line results from Phase III study of aclidinium bromide announced

Jan 7 2010

Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced positive top-line results from ACCORD COPD I, a three-month Phase III study comparing aclidinium 200µg and 400µg BID versus placebo. Aclidinium bromide produced statistically significant (p<0.0001) changes from baseline in morning pre-dose (trough) FEV₁ versus placebo at week 12, which was the primary endpoint for the study. Changes from baseline values in morning trough FEV₁ compared to placebo were 86mL and 124 mL for the 200µg and 400µg BID groups, respectively. This is the first of three pivotal Phase III studies investigating the BID administration of aclidinium in COPD patients.

“Together, these data suggest that aclidinium administered BID provides a clinically important bronchodilatory effect with good tolerability in patients with COPD.”

Aclidinium was well tolerated in this study. The percentage of patients reporting adverse events and serious adverse events was similar across the study treatment arms. The most frequent adverse event observed was COPD exacerbation, which occurred in 9.2%, 7.4% and 12.4% of patients receiving aclidinium 200µg, aclidinium 400µg and placebo, respectively. Other frequently observed adverse events included dyspnea, headache and nasopharyngitis and occurred at similar rates across the treatment groups.

“We are very pleased with the results of this study which confirm the decision made by Forest and Almirall to investigate a BID dosing regimen for aclidinium”, said Lawrence S. Olanoff, President and Chief Operating Officer of Forest Laboratories. “Together, these data suggest that aclidinium administered BID provides a clinically important bronchodilatory effect with good tolerability in patients with COPD.”

These top-line results are consistent with previously announced positive findings from a 15 day, Phase II study comparing aclidinium bromide 400µg BID, tiotropium 18µg once daily (QD) and placebo. In this Phase II study, both products showed a statistically significant difference in normalized AUC (0-12 hours) FEV₁ compared to placebo (p<0.0001). Improvements versus placebo for aclidinium and tiotropium in terms of normalized AUC (12-24 hours) FEV1 on Day 15 were also statistically significant and the effect was significantly higher for aclidinium than tiotropium during the 12-24 hour period>

”We are encouraged by the positive top-line results shown in this Phase III study. Taken together with the Phase II study vs tiotropium, it indicates that aclidinium bromide BID provides significant bronchodilation and is well tolerated in patients with moderate to severe COPD”, said Per-Olof Andersson, Executive Director Research and Development at Almirall. ”We look forward to presenting full results from both studies at upcoming scientific meetings and in publications."

The Phase II and III studies above are part of Almirall and Forest’s ongoing development program for aclidinium bromide. Two additional placebo-controlled Phase III studies (ACCORD COPD II and ATTAIN) assessing efficacy and safety in patients with COPD are currently underway, one in North America and the other in Europe and the rest of the world. Results from these studies are expected to be available between the second half of 2010 and early 2011.