Forest, Almirall to present data on aclidinium bromide for COPD and LAS100977 for asthma at ATS conference

May 11 2010

Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC) today announced that they are presenting data from several studies of two investigational inhaled respiratory compounds at the annual American Thoracic Society International Conference taking place in New Orleans May 14-19, 2010. Data on aclidinium bromide, an inhaled muscarinic antagonist, which is in Phase III development for COPD, and LAS100977, a long-acting beta 2-agonist, in Phase II development for asthma, will be presented in 11 separate posters. In addition, 3 posters reporting data on the Genuair^® inhaler, which is used to administer the compounds, will be presented.

“We are pleased to have the opportunity, along with our partner Almirall, to present data on two of our key pipeline products at the ATS conference. The data presented here reinforce the commitment we have to the development of useful treatments for important respiratory diseases”

"We are pleased to have the opportunity, along with our partner Almirall, to present data on two of our key pipeline products at the ATS conference. The data presented here reinforce the commitment we have to the development of useful treatments for important respiratory diseases," said Lawrence S. Olanoff, President and Chief Operating Officer of Forest Laboratories.

Key Aclidinium Bromide Data - Tuesday, May 18th

The following study results will be presented:

• Efficacy and safety of aclidinium bromide 400 µg BID compared with placebo and tiotropium in patients with moderate to severe COPD (F77, H. Magnussen)
• Aclidinium bromide improves exercise endurance, dyspnea and inspiratory capacity in patients with moderate to severe COPD (F65, F. Maltais)
• Safety and tolerability of aclidinium bromide administered intravenously and absolute bioavailability of inhaled aclidinium bromide in healthy subjects (F101, S. Ortiz)
• Pharmacokinetics of aclidinium bromide 200 µg and 400 µg in young and elderly patients with chronic obstructive pulmonary disease (F83, S. de la Motte)
• Metabolism and excretion of aclidinium bromide following intravenous administration of [¹⁴C] aclidinium bromide in healthy subjects (F100, S. Flach)

In addition, two preclinical studies characterizing the profile of aclidinium by comparison to glycopyrrolate will be presented (A55, J. Beleta and F85, A. Galvada).

Key LAS100977 Data - Wednesday, May 19th

The following two clinical posters will be presented:

• Efficacy and safety of single inhaled doses of LAS100997, a novel long acting B2-agonist in patients with persistent asthma (221, J. Beier)
• Single doses of LAS100977, a novel long acting beta 2-agonist, show high activity and long duration in healthy subjects (E31, W. Timmer)

In addition, two preclinical studies assessing the potency, selectivity and duration of action for LAS100977 will be presented (E43, M. Aparici and E44, M. Miralpeix).

Genuair® Inhaler Data

Three posters assessing the reliability of the technical features of the inhaler, stability of aclidinium bromide in the inhaler under various storage conditions, and aerodynamics and particle size of aclidinium bromide administered using the inhaler will be presented (B57, R. Greguletz, B56, K. Block, and B58, K. Block).

"The studies being presented here demonstrate that aclidinium bromide administered BID provides significant bronchodilation and is well tolerated," said Per-Olof Andersson, Chief Scientific Officer at Almirall. "Additionally the results of the LAS100977 studies show that the compound has potential for the treatment of respiratory diseases. The presentations further explain the reliability and technical features of the Genuair® inhaler used to effectively deliver both compounds."