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Almirall and Forest to present data from studies of Eklira® (aclidinium bromide) in Chronic Obstructive Pulmonary Disease (COPD) and LAS100977 in asthma
·Data to be presented at 2010 American Thoracic Society International Conference
Barcelona May 11, 2010 – Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE: FRX) today announced that the companies 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 Eklira®[i](aclidinium bromide), an inhaled muscarinic antagonist which is in Phase III development for COPD, and the long acting beta agonist (LABA) LAS100977 in Phase II development for asthma, will be presented in 11 separate posters. In addition, three posters reporting data on the Genuair® 1 inhaler, which is used to administer the compounds, will be presented.
"The studies being presented at the ATS demonstrate that Eklira® administered BID provides significant bronchodilation and is well tolerated;"said Per-Olof Andersson, Chief Scientific Officer at Almirall. "Additionally the results of the LAS100977studies show that the compound has potential for the treatment of respiratory diseases. The presentations will further explain the reliability and technical features of the Genuair® inhaler used to effectively deliver both compounds".
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, Magnussen, H)
·Aclidinium bromide improves exercise endurance, dyspnea and inspiratory capacity in patients with moderate to severe COPD (#F65, Maltais, F)
·Safety and tolerability of aclidinium bromide administered intravenously and absolute bioavailability of inhaled aclidinium bromide in healthy subjects (#F101, Ortiz, S)
·Pharmacokinetics of aclidinium bromide 200 µg and 400 µg in young and elderly patients with chronic obstructive pulmonary disease (#F83, de la Motte, S)
·Metabolism and excretion of aclidinium bromide following intravenous administration of [14C] aclidinium bromide in healthy subjects (#F100, Flach, S)
In addition to those above, two preclinical studies characterizing the profile of aclidinium by comparison to glycopyrrolate will be presented. (#A55, #F85)
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 Beier, J)
·Single doses of LAS1009977, a novel long acting B2-agonist, show high activity and long duration in healthy subjects (#E31, Wolfgang, T)
In addition, two preclinical studies assessing the potency, selectivity and duration of action for LAS100977 will be presented. (#E43, Aparici, M and #E44 Miralpeix, M)
Genuair® inhaler data
Three posters assessing the reliability of the technical features of the inhaler, stability of Eklira® (aclidinium bromide) in the inhaler under various storage conditions, and aerodynamics and particle size of aclidinium bromide administered using the inhaler will be presented. (#1710, #1733, #1739)
"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.
About aclidinium bromide and the Genuair® inhaler
Eklira® (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 US 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.
Eklira® is administered to patients using the novel, state-of-the-art, multidose dry powder inhaler (MDPI), Genuair®. The Genuair® inhaler was designed with an intuitive feedback system, which through a 'coloured 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.
About LAS100977
LAS100977 is a highly potent, novel, once daily long-acting beta2 agonist (LABA) that in early Phase II testing demonstrated fast onset and long-lasting (24-hour) bronchodilator 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 commercialises 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.
Media contact:
Ketchum Pleon UK
Amanda Sefton - +44 20 7611 3653 / +44 7707 812968
Annabel Gillett + 44 20 7611 3559
[i]Eklira® and Genuair® are trademarks owned by Almirall, S.A. and their use is pending approval from the appropriate regulatory authorities.
Press release