Forest and Almirall to Present Data from Studies of Aclidinium Bromide in Chronic Obstructive Pulmonary Disease (COPD) and LAS100977 in Asthma

--Data to be presented at 2010 American Thoracic Society International Conference--

NEW YORK--(BUSINESS WIRE)--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,” 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."

About aclidinium bromide and the Genuair® inhaler

Aclidinium bromide, which is in Phase III testing for COPD, is a novel, long-acting inhaled anticholinergic bronchodilator which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest Laboratories, Inc. licensed U.S. rights for aclidinium from Almirall, while Almirall maintains rights for the rest of the world. The companies are jointly involved in the development of the compound.

Aclidinium bromide is administered to patients using a novel, state-of-the-art multidose dry powder inhaler (MDPI), Genuair®. The Genuair® inhaler was designed with an easy-to-use intuitive feedback system, which through a 'colored control window' and an audible click confirms that the patient has inhaled correctly. It contains multiple doses of aclidinium, includes a visible dose-level indicator, and also incorporates significant safety features such as an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.

Genuair® is a trademark owned by Almirall, S.A.

About LAS100977

LAS100977 is a highly potent, novel, once daily long-acting beta 2-agonist (LABA) that in early Phase II testing demonstrated fast onset and long-lasting (24-hour) bronchodilating effects with a good tolerability profile in patients with stable asthma after multiple dosing. Forest entered an agreement with Almirall to develop, market and distribute LAS100977 in the United States in December 2009. The compound will be developed in combination with an undisclosed corticosteroid using Almirall's proprietary Genuair® inhaler for the treatment of both asthma and COPD.

About Almirall

Almirall, an international pharmaceutical company based on innovation and committed to health, headquartered in Barcelona, Spain, researches, develops, manufactures and commercializes its own R&D and licensed drugs with the aim of improving people's health and wellbeing.

The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology in general.

Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 11 affiliates.

For further information, please visit www.almirall.com.

About Forest Laboratories

Forest Laboratories, Inc. (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.

 

Contact: Forest Laboratories, Inc
Frank J. Murdolo, +1-212-224-6714
Vice President - Investor Relations
Frank.Murdolo@frx.com

 

Posted: May 2010

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