Data Presented at the 2008 International Conference of the American
Thoracic Society
TORONTO, May 20 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and
Laboratorios Almirall, S.A. today 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
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<0.05 vs placebo). There
was a dose response observed for lung function improvement with once-daily
aclidinium. Aclidinium was well tolerated, with no dose-dependent effect on
ECG, laboratory parameters, or adverse events. Overall, the most frequently
reported adverse events were headache (4.1% of patients), dry mouth (2.8%
of patients), exacerbation of chronic obstructive airways disease (1.7% of
patients) and cough (1.7% of patients). Based on these results, aclidinium
200 mcg administered once every 24 hours was selected as the dose for
investigation in the two ongoing Phase III clinical trials, ACCLAIM COPD I
and II, which are expected to report out during the second half of this
year.
"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."
Additional Clinical Data
Three additional clinical trials assessing the safety and
pharmacokinetics of aclidinium were also presented at this meeting.
A randomized, double-blind, placebo- and active-controlled clinical
trial evaluating the cardiovascular safety and pharmacokinetics of
aclidinium (200 or 800 mcg) in 272 healthy subjects, showed no effect on QT
interval at doses up to 800 mcg. Furthermore, aclidinium was
well-tolerated, with most adverse events being of mild intensity, related
to electrode attachment, and of similar incidence across treatment groups.
Maximum concentration of aclidinium was reached 5 to 30 minutes post-dose
and aclidinium was not detectable in the plasma after one hour.
Results of two other randomized, placebo-controlled studies, each in 16
healthy subjects, were presented. In the first, subjects were exposed to
single doses of aclidinium (600 -- 6000 mcg) and placebo to determine
pharmacokinetics, safety and tolerability, and maximum tolerated dose. For
all doses, aclidinium was undetectable in plasma beyond 3 hours post-dose.
Aclidinium was well tolerated across this dosage range, with headache
(n=10) and fatigue (n=5) being the most frequently reported adverse events.
No serious adverse events were reported. The second study assessed the
safety, tolerability, and pharmacokinetics of aclidinium after multiple
doses. Subjects received 5 days of treatment with aclidinium 200, 400, 800
mcg or placebo. Aclidinium was undetectable in plasma after all studied
doses beyond 1 hour post-dose. Aclidinium was well tolerated at all doses,
and the majority of AEs were considered mild. The most commonly reported
adverse events were coughing (n=2) and dysphagia (n=1). One serious AE
(hospitalization due to severe diarrhea) occurred after the last dose of
800 mcg and was judged by the investigator as unrelated to treatment. There
were no clinically relevant changes in laboratory parameters, vital signs
or ECG.
"These clinical data suggest that aclidinium may be a valuable
treatment option for patients suffering from COPD," said Dr. Jorge
Gallardo, Chairman and Chief Executive Officer of Almirall. "We remain
committed to our partnership with Forest Laboratories to jointly develop
aclidinium."
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. In addition, aclidinium had a potent and long-lasting
effect on preventing bronchoconstriction in both the human bronchi and
several animal models assessed.
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. 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. 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.
About Forest Laboratories and Its Products
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 http://www.frx.com.
* Campral is a registered trademark of Merck Sante s.a.s., a subsidiary of
Merck KGaA, Darmstadt, Germany.
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.
For further information please visit the website at: http://www.almirall.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.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
http://www.almirall.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Investors: Charles E. Triano, Vice
President-Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Charles.Triano@frx.com, or Jordi Molina, Head
Investor Relations of Laboratorios Almirall, S.A.,
jordi.molina@almirall.es; Media: Rachel Bannister of Tonic Life
Communications for Laboratorios Almirall, S.A.,
+44(0)20-798-9900, Rachel.Bannister@toniclc.com
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