Forest & Almirall Announce Positive FDA Advisory Committee’s Recommendation for Approval of Aclidinium Bromide for the Trea...
February 23 2012 - 7:00PM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC)
announced today that the U.S. Food and Drug Administration’s (FDA)
Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 12 to 2 in
favor of approving the New Drug Application (NDA) for aclidinium
bromide, a new long-acting antimuscarinic for the maintenance
treatment of COPD. The Committee was also asked to separately
evaluate if the efficacy and safety of the 400 ug twice daily dose
had been adequately demonstrated. The members voted unanimously in
favor of efficacy and 10 to 3 (1 member abstained) in favor of
safety.
Today’s committee recommendations, although not binding, will be
considered by the FDA as it completes its review of the NDA for
aclidinium bromide. Forest and Almirall anticipate receiving FDA
feedback on the filing in the second quarter of calendar year
2012.
About aclidinium bromide
Aclidinium bromide is a novel, long-acting inhaled
antimuscarinic agent, which is 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 to two major inactive metabolites. Forest Laboratories, Inc.
licensed U.S. rights for aclidinium from Almirall, Kyorin for Japan
and Daeowoong for Korea while 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 the 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 percent of all deaths globally that year.
Total deaths from COPD are projected to increase by more than 30
percent in the next 10 years without interventions to cut risks,
particularly exposure to tobacco smoke.
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 (Chronic Obstructive
Pulmonary Disease), 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.
Photo Notes:
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