Forest and Almirall to Present Aclidinium Bromide Clinical Data at the American Thoracic Society (ATS) International Conference
May 18 2012 - 6:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A.
(ALM.MC) today announced that they will present aclidinium-related
data in 1 poster discussion session and 3 poster presentations at
the American Thoracic Society (ATS) International Conference
scheduled May 18 - 23 in San Francisco, CA. Positive top-line
results from the aclidinium pivotal double-blind placebo-controlled
studies were first reported in 2011. Aclidinium bromide is a new,
inhaled long-acting antimuscarinic agent currently under review by
the FDA for the maintenance treatment of Chronic Obstructive
Pulmonary Disease (COPD).
The poster discussion titled “Long-Term Efficacy And Safety of
Twice-Daily Aclidinium Bromide in COPD Patients: A One-Year Study”
will take place on Sunday, May 20 from 2:00 - 4:30 pm. This
presentation will report the results from the long-term efficacy
and safety study of aclidinium bromide in 600 patients over 52
weeks of treatment.
In addition, there will be the following poster
presentations:
- Long-Term Extension Study Of ACCORD
COPD I: Effects Of Two Doses Of Twice-Daily Aclidinium Bromide In
COPD Patients (Poster D43: Monday, May 21 from 8:15 am - 4:30
pm)
- Nighttime Symptoms Of COPD And
Associated Reductions In Quality Of Life In A Clinical Trial
Population (Poster D56: Wednesday, May 23 from 8:15 am - 4:30
pm)
- COPD Patients’ Experience Of Early
Morning Symptoms: Results From Qualitative Research (Poster D57:
Wednesday, May 23 from 8:15 am - 4:30 pm)
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 multi-dose 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
COPD, or Chronic Obstructive Pulmonary Disease, is a common,
progressive, and debilitating lung disease characterized by
persistent airflow limitation that makes it hard to breathe. 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. COPD is already the third leading cause of death
in the United States.
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, respiratory,
gastrointestinal and pain management medicine. Forest’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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