Forest Laboratories and Almirall Announce FDA has Extended the Review Period for Aclidinium Bromide
March 29 2012 - 2:30AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC)
announced today that the U.S. Food and Drug Administration (FDA)
will require a three-month extension to complete its review of the
data supporting the New Drug Application (NDA) for aclidinium
bromide, a new long-acting antimuscarinic for the maintenance
treatment of Chronic Obstructive Pulmonary Disease (COPD). No
additional data has been requested by the agency to complete the
review. FDA action is now expected by July 2012.
This FDA notification follows the Pulmonary-Allergy Drugs
Advisory Committee (PADAC) February 2012 meeting during which the
committee endorsed the efficacy and safety of twice-daily
aclidinium bromide 400ug with a positive 12 to 2 vote in favor of
approval.
The efficacy and safety of aclidinium was studied in a clinical
trial program including 2,717 COPD patients in 9 studies. In these
trials, aclidinium demonstrated significant improvement in lung
function, with a low incidence of side effects, comparable to
placebo.
About aclidinium bromide
Aclidinium bromide is a novel, long-acting inhaled
antimuscarinic agent, often referred to as an anticholinergic, that
has a long residence time at M3 receptors and a shorter residence
time at M2 receptors. When given by inhalation, aclidinium leads to
bronchodilation by inhibiting airway smooth muscle contraction.
Aclidinium is rapidly hydrolyzed in human plasma into two major
inactive metabolites. Forest Laboratories, Inc. licensed U.S.
rights for aclidinium from Almirall, while Kyorin Pharmaceutical
Co., Ltd holds marketing rights in Japan and Daewoong
Pharmaceutical Co., Ltd is licensed to market aclidinium in Korea.
Almirall has recently given rights of joint commercialization in
the majority of European member states and a number of non-EU
countries to Menarini. Almirall maintains rights for the rest of
the world. Almirall and Forest are jointly involved in the
development of the compound.
Aclidinium bromide was administered to patients in trials using
a novel, investigational state-of-the-art multidose dry powder
inhaler (MDPI). This inhaler was designed with a feedback system
which, through a ‘colored control window’ and an audible click,
helps confirm that the patient has inhaled correctly. It contains
multiple doses of aclidinium, includes a visible dose-level
indicator, and also incorporates 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 COPD
The World Health Organization (WHO) has described COPD as a
global epidemic; an estimated 64 million people have COPD
worldwide. 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. WHO predicts that COPD will become the
third leading cause of death worldwide by 2030.
In patients with COPD the airways in the lungs typically lose
their elasticity, produce excess mucus and become thick and
inflamed, limiting the passage of air. 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. New therapies to treat this debilitating disease may be of
value.
About Almirall
Almirall is an international pharmaceutical company based on
innovation and committed to health. Headquartered in Barcelona,
Spain, it researches, develops, manufactures and commercializes its
own R&D and licensed drugs with the aim of improving people’s
health and wellbeing.
Almirall focuses its research resources on therapeutic areas
related to the treatment of asthma, COPD, gastrointestinal
disorders, psoriasis and other dermatological conditions.
Almirall’s products are currently present in more than 70
countries while it has direct presence in Europe and Latin America
through 12 affiliates.
For further information please visit: www.almirall.com.
About Forest Laboratories
Forest Laboratories' (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory
medicine. The Company's pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more, 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 Reports on Form
10-Q, and any subsequent SEC filings.
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