Laboratorios Almirall, S.A. and Forest Laboratories, Inc. presented
results from four clinical trials assessing the efficacy and
safety of aclidinium bromide, an investigational treatment for chronic
obstructive pulmonary disease (COPD). Data from four preclinical studies
further describing the properties of aclidinium were also presented at the
meeting.
Presentations included data from a 464-patient randomized,
double-blind, four-week, Phase IIb study that evaluated both the efficacy and
tolerability of once-daily aclidinium (25 mcg, 50 mcg, 100 mcg, 200 mcg or
400 mcg) or placebo in patients with moderate to severe COPD. An open-label
tiotropium (18 mcg) arm was included as an active control. The study
demonstrated aclidinium (200 mcg and 400 mcg), administered via a multi-dose
dry powder inhaler, significantly increased trough (24 hour) forced
expiratory volume in one second (FEV1) - an important measure of lung
function - on Day 29 compared with placebo (p
"There are still significant unmet needs in the treatment of
COPD. These efficacy and safety data from the Phase II trials are very
encouraging," said Lawrence S. Olanoff, M.D., Ph.D., President and Chief
Operating Officer of Forest Laboratories. "We look forward to the completion
of ACCLAIM I & II trials and continuing the clinical development of
aclidinium for the treatment of COPD."
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.(5) In addition, aclidinium had a potent
and long-lasting effect on preventing bronchoconstriction in both the human
bronchi and several animal models assessed. (6),(7)
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, whilst keeping rights for the rest of the
world. 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.(8) 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.(9)
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 COPD (Chronic Obstructive Pulmonary
Disease), asthma, psoriasis, rheumatoid arthritis and multiple sclerosis.
Almirall's medicines are currently present in over 70
countries with direct presence in Europe and Latin America.
almirall
About Forest Laboratories
Forest Laboratories is a U.S.-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Campral(R)* (acamprosate calcium),
indicated in combination with psychosocial support for the maintenance of
abstinence from alcohol in patients with alcohol dependence who are abstinent
at treatment initiation; and Bystolic(R) (nebivolol), a beta-adrenergic
receptor blocking agent indicated for the treatment of hypertension. For more
information, visit frx.
* Campral is a registered trademark of Merck Sant?© s.a.s., a subsidiary
of Merck KGaA, Darmstadt, Germany.
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.
References
(1) Chanez P, Burge S, Dahl R, et al. Once-daily administration of
aclidinium bromide, a novel, long-acting anticholinergic: a Phase II, dose
finding study. American Thoracic Society, May 2008. Poster.
(2) Lasseter KC, Aubets J, Gil E Garcia. Aclidinium bromide, a novel
long-acting anticholingergic, does not affect QT interval in health subjects.
American Thoracic Society, May 2008. Poster.
(3) Ferrer P, Jansat JM, Gil E Garcia. Pharmokinetics and safety of
aclidinium bromide, a novel long-acting, inhaled anticholinergic, in healthy
subjects. American Thoracic Society, May 2008. Poster.
(4) De Miquel G, Schr?¶dter A, Miletzki B, et al. Low systemic exposure to
aclidinium bromide, a novel long-acting anticholinergic, after multiple
doses. American Thoracic Society, May 2008. Poster.
(5) Gras J, Gavald? A, Llenas J. The preclinical cardiovascular safety
profile of aclidinium bromide, a novel long-acting anticholinergic drug.
American Thoracic Society, May 2008. Poster.
(6) Miralpeix M, Otal R, Carre?±o C, et al. Aclidinium bromide, a novel
anti-muscarinic, reverses cholinergic-induced bronchoconstriction with a fast
onset of action and a long-lasting effect in guinea pigs. American Thoracic
Society, May 2008. Poster.
(7) Cortijo J, Sarri?? B, Gavald? A. In vitro characterization of
aclidinium bromide, a novel long-acting anticholinergic: effects on isolated
human bronchi. American Thoracic Society, May 2008. Poster.
(8) Global Initiative for Chronic Obstructive Lung Disease. Global
strategy for diagnosis, management, prevention of COPD
(goldcopd) accessed 3 September 2007.
(9) World Health Organisation (WHO). Chronic obstructive pulmonary
disease (COPD). Factsheet number 315; November 2006.
almirall
View drug information on Campral.
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