Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium...

Forest and Almirall Announce Positive Results of Clinical Studies for
Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for
COPD
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.
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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 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: 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.

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