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 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: 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.
SOURCE Forest Laboratories, Inc.
CONTACT:
Frank J. Murdolo, Vice President - Investor Relations of
Forest
Laboratories, Inc., +1-212-224-6714,
Frank.Murdolo@frx.com
Web Site: http://www.frx.com
(FRX)