Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Progr
March 06 2009 - 2:30AM
PR Newswire (US)
NEW YORK, March 6 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) and Laboratorios Almirall, S.A. today announced
after consultation with the U.S. Food and Drug Administration
(FDA), that additional clinical studies of aclidinium bromide for
the treatment of chronic obstructive pulmonary disease (COPD) will
be conducted to provide further support for the selected regimens,
including higher and/or more frequent doses. This decision follows
a meeting with the FDA to review the previously reported
ACCLAIM/COPD I and II studies. The Companies originally anticipated
filing a New Drug Application (NDA) in the fourth quarter of 2009
or the first quarter of 2010, pending FDA feedback. Timelines for
the development of the additional clinical studies and the future
filing date of an NDA, including the ACCLAIM studies, are being
determined. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) About
COPD The World Health Organization (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(1). 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)(2). Genuair(R) was designed with an intuitive feedback
system, which through a 'colored control window' and an audible
click indicates that the patient has inhaled correctly. The
Genuair(R) inhaler contains multiple 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 U.S.-based
pharmaceutical company with a long track record of building
partnerships and developing and marketing 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 Report 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) WHO fact sheet 315. May 2008. Chronic
obstructive pulmonary Disease (COPD). (2) 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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Frank J. Murdolo, Vice President
- Investor Relations of Forest Laboratories, Inc., +1-212-224-6714,
Web Site: http://www.frx.com/ Company News On-Call:
http://www.prnewswire.com/comp/329163.html
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