NEW YORK, Sept. 3 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Laboratorios Almirall, S.A. today announced results from
two global Phase III studies of aclidinium bromide, a novel long-acting
inhaled anticholinergic for the treatment of patients with chronic
obstructive pulmonary disease (COPD). In both the ACCLAIM/COPD I&II
(AClidinium CLinical Trial Assessing Efficacy and Safety In Moderate to
Severe COPD Patients) studies, once-daily aclidinium bromide showed a
statistically significant difference vs. placebo in the primary endpoint
trough FEV1, a measure of pulmonary function that is decreased in moderate
to severe COPD patients.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
In both studies aclidinium therapy demonstrated a significant
difference vs placebo in trough FEV1 at 12 weeks (p-value <0.001) and 28
weeks (p-value <0.001). The effect of aclidinium compared to placebo in
trough FEV1 was maintained over one year (p-value <0.001). The improvement
in the trough FEV1, at weeks 12 and 28, of aclidinium arms compared to
placebo was in the range of 60 to 70 mL in both trials. The change from
baseline in peak FEV1 observed after dosing aclidinium compared to placebo
at 12 and 28 weeks was between 154 and 177 mL (p-value <0.0001), with a
median time to peak of 2 hours.
"The studies confirm the bronchodilatory effect of aclidinium at the
dose tested, although the magnitude was lower than seen in previous
studies. We are working actively with Forest and members of the
ACCLAIM/COPD Steering Committee to fully understand these findings to
determine the best way forward including the extent of the benefit possible
from dosing alternatives", commented Per-Olof Andersson, Executive Director
R&D of Almirall.
Aclidinium significantly improved the percentage of patients showing a
clinically relevant improvement (greater than or equal to 4 points) in
health-related quality of life compared with placebo in the ACCLAIM/COPD I
study (week 52; p-value=0.025) as measured by the St. George's Respiratory
Questionnaire (SGRQ). ACCLAIM/COPD II did not reach statistical
significance for SGRQ at week 52 (p-value=0.074), however the study showed
statistical significance at all previous time-points (p-value<0.001).
Pooled analysis of both studies showed a statistically significantly higher
percentage of patients improving greater than or equal to 4 units in the
SGRQ at week 52 (p- value=0.04).
Secondary endpoint results demonstrated that aclidinium significantly
delayed the time to the first moderate to severe exacerbation in patients
with COPD in ACCLAIM/COPD II (p-value=0.01), whereas results were not
significant in ACCLAIM/COPD I. In the pooled analysis of both studies,
there was a positive trend in delaying the time to first moderate or severe
exacerbation (p-value=0.054).
"Forest is pleased with the results of these studies and remains
committed with Almirall to the development of aclidinium bromide in COPD",
said Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories.
ACCLAIM/COPD study design and results
Two double-blind, multicenter, parallel-group, placebo-controlled Phase
III studies were conducted, one in Europe (ACCLAIM/COPD I) and the other
primarily in North America (ACCLAIM/COPD II), to evaluate the efficacy and
safety of inhaled aclidinium administered once daily. A total of 1,647
patients, across 23 countries participated in these trials. Patients had a
diagnosis of moderate to severe COPD and were a minimum of 40 years of age
with at least a 10 pack-year smoking history. The mean FEV1 values at
baseline were 1.406 and 1.199L for ACCLAIM/COPD I and ACCLAIM/COPD II,
respectively. Patients were randomized to receive aclidinium bromide (200
micrograms once daily) or placebo over a one-year treatment period.
The primary endpoints for ACCLAIM/COPD I and II were bronchodilation at
the end of the dosing interval, assessed as trough FEV1 (measured at 23-24h
post-dose). For both trials, the primary endpoint was measured at week 12
and week 28 to fulfill FDA and European requirements, respectively.
Aclidinium bromide and placebo were administered to patients using the
Genuair(R)(1) device, a multi-dose dry powder inhaler which operates by a
'one press and inhale' technique.
Overall, safety and tolerability were comparable between aclidinium and
placebo in terms of percentage of patients with Serious Adverse Events
(aclidinium: 9.1%, placebo 10.7%), Fatal Adverse Events (aclidinium: 1.1%,
placebo: 1.7%), or with Adverse Events leading to treatment discontinuation
(aclidinium: 4.0%, placebo: 5.7%). The most frequently reported adverse
events across both studies were nasopharyngitis (aclidinium: 14.5%,
placebo: 12.9%) and headache (aclidinium: 12.7%, placebo: 12.6%). Potential
anticholinergic adverse events were observed in a similarly low percentage
of patients, (e.g. dry mouth - aclidinium: 0.7%, placebo: 1.2%).
"Almirall remains committed to continue the efforts to provide
treatment options for COPD patients with aclidinium bromide", commented
Jorge Gallardo, Chairman and Chief Executive Officer of Almirall.
About COPD
The World Health Organisation (WHO) has described COPD as a global
epidemic; an estimated 210 million people have COPD worldwide and more than
3 million people died of the condition in 2005, which is equal to 5% of all
deaths globally that year. Total deaths from COPD are projected to increase
by more than 30% in the next 10 years without interventions to cut risks,
particularly exposure to tobacco smoke.
The most common symptoms of COPD are breathlessness (or a "need for
air"), abnormal sputum (a mix of saliva and mucus in the airway), and a
chronic cough. Daily activities, such as walking up a short flight of
stairs or carrying a suitcase, can become very difficult as the condition
gradually worsens(2). There are significant unmet needs in the treatment of
COPD including limited therapeutic options to improve lung function and
control exacerbations.
About aclidinium bromide and Genuair(R)
Aclidinium bromide 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 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.
Aclidinium bromide is administered to patients using a novel,
state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R).
Genuair(R) was designed with an intuitive feedback system, which through a
'coloured control window', an audible click and a slightly sweet taste
indicates that the patient has inhaled correctly. The Genuair(R) inhaler
contains 30 doses with 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 Forest Laboratories
Forest Laboratories (NYSE: FRX) is a US-based pharmaceutical company
with a long track record of building partnerships and developing and
delivering 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 http://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.
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 is currently present in over 70 countries with direct presence
in Europe and Latin America through 11 affiliates.
For further information please visit the website at: http://www.almirall.com
(1) Genuair is a registered trademark of Laboratorios Almirall, S.A. It is
the proposed registered trademark for the Multiple-Dose Dry Powder
Inhaler (MDPI) and is pending regulatory approval.
(2) WHO fact sheet 315. May 2008. Chronic obstructive pulmonary disease
(COPD).
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:
Frank Perier, Jr. Senior Vice President -
Finance and Chief Financial Officer of Forest Laboratories, Inc.,
+1-212-224-6611, Frank.Perier@frx.com; or Helen Swift, Senior
Account Manager, direct +44-(0)- 207798-9924, mobile
+44-(0)-77-7966-0939, or Scott A. Clark, Chief Executive Officer,
direct +44-(0)-20-7798-9901, fax +44-(0)-20-7233-8780, both of
Tonic Life Communications Ltd., +44-(0)-20-7798-9900, for
Almirall
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