BARCELONA, Spain and
NEW YORK, July 24, 2012 /PRNewswire/ --
- COPD is currently the third leading cause of mortality in
the USA
- Tudorza™ Pressair™ (aclidinium bromide inhalation powder)
will be available in the fourth quarter 2012
- European approval of aclidnium expected in Q3 2012
Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE:FRX)
announced that the U.S. Food and Drug Administration (FDA) has
approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder)
for the long-term maintenance treatment of bronchospasm associated
with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema.
COPD is a common, progressive, and debilitating lung disease
characterized by persistent airflow limitation that makes it hard
to breathe; it is currently the third leading cause of mortality in
the US. Characteristic symptoms include breathlessness, excessive
production of sputum, and a chronic cough.
Tudorza™ is a twice-daily inhaled long-acting anticholinergic,
also referred to as a long-acting muscarinic antagonist (LAMA).
Tudorza™ produces bronchodilation by inhibiting acetylcholine's
effect on muscarinic receptors in the airway smooth muscle. Forest
expects Tudorza™ Pressair™ to be available to wholesalers in the
fourth calendar quarter of 2012.
"The FDA approval of Tudorza™ Pressair™
demonstrates our steadfast commitment to the development of
respiratory compounds, such as aclidinium, innovative delivery
devices, and our unfailing belief in their potential for the
treatment of COPD. Today, we celebrate this achievement for our
company and, most importantly, for the patients we
serve," commented Jorge
Gallardo, President of Almirall.
"We are pleased with the FDA approval of Tudorza.
As the first long-acting inhaled anticholinergic agent
approved in over 8 years for COPD, Tudorza will be an important
treatment option available for the millions of patients living with
this serious disease. Tudorza's approval marks an
important milestone in our ongoing partnership with Almirall and
advances Forest's respiratory franchise and our
commitment to COPD patients," commented Howard Solomon, Chairman, Chief Executive
Officer, and President of Forest Laboratories.
Professor Richard Casaburi, MD,
Associate Chief for Research in the Division of Respiratory and
Critical Care Physiology and Medicine, Harbor-UCLA Medical Center,
stated, "the Global Initiative for Chronic
Obstructive Lung
Disease 2011 guidelines recommendlong-acting
anticholinergics as a first-line therapy for a broad
range of COPD patients with moderate to very severe
disease. Tudorzawill be a
valuable anticholinergic option in the
clinical armamentarium available to manage this serious
disease."
Data Highlights
The Tudorza™ Pressair™ clinical development program included a
dose-ranging trial and 3 confirmatory pivotal trials. The two
12-week and one 24-week pivotal placebo-controlled trials evaluated
the efficacy and safety of Tudorza™ 400 mcg twice daily in 1,277
patients. Patients enrolled in these trials had a clinical
diagnosis of COPD, were 40 years of age or older, had a smoking
history of at least 10 pack-years, a post-bronchodilator forced
expiratory volume in one second (FEV1) of at least 30%
and less than 80% of predicted normal value, and a ratio of
FEV1 over forced vital capacity (FEV1/FVC) of
less than 0.7.
In all 3 pivotal trials, Tudorza™ Pressair™ demonstrated
statistically significant improvements in bronchodilation, as
measured by change from baseline in morning pre-dose trough
FEV1 at 12 weeks (the primary endpoint) compared to
placebo. The mean 12-week pre-dose FEV1 improvements vs
placebo were 0.12 L, 0.07 L, and 0.11 L in the 3 trials, with a
24-week improvement of 0.13 L in the 6-month trial. Mean peak
improvements in lung function assessed after the first dose of
Tudorza were similar to those observed at week 12 in each study.
Tudorza™ had a low incidence of side effects in these trials.
The most common adverse reactions that occurred in the Tudorza™
Pressair™ group with a frequency of greater than or equal to 3% and
exceeding placebo were headache (6.6% vs 5.0%), nasopharyngitis
(5.5% vs 3.9%), and cough (3.0% vs 2.2%). Three long-term safety
studies, evaluating 891 patients treated with Tudorza™ Pressair™
400 mcg twice daily for 40 to 52 weeks reported similar adverse
events, with no new safety findings compared to the
placebo-controlled trials.
Additionally, serial spirometric evaluations of FEV1
were performed over 12 hours in a subset of patients in the three
trials. Improvement of lung function with Tudorza™ Pressair™ versus
placebo was achieved for the first 12 hours on day 1 and was
consistent over the 3- or 6-month treatment period evaluated.
In two of the three trials, patients treated with Tudorza
Pressair also used less daily rescue albuterol compared to placebo
treated patients.
About Tudorza™ Pressair™
Tudorza™ Pressair™ (aclidinium bromide inhalation powder) 400
mcg is an anticholinergic indicated for the long-term maintenance
treatment of bronchospasm associated with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and
emphysema. When given by inhalation, aclidinium produces
bronchodilation by inhibiting the muscarinic M3 receptor in the
airway smooth muscle. Aclidinium is rapidly hydrolyzed in human
plasma into two major inactive metabolites.
Tudorza is administered using a multiple-dose dry powder
inhaler, Pressair, which delivers 60 doses of aclidinium bromide
powder for inhalation. The Pressair inhaler has a colored control
window and audible "click" which confirm successful inhalation of
the dose and a dose indicator to let patients know the approximate
number of doses remaining in the inhaler.
In 2005, 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.
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 U.S.
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 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.
Important Safety Information
Tudorza™ Pressair™ is not indicated for the initial treatment of
acute episodes of bronchospasm (i.e., rescue therapy).
Inhaled medicines, including Tudorza, may cause paradoxical
bronchospasm. If this occurs, treatment with Tudorza should be
stopped and other treatments considered.
Tudorza should be used with caution in patients with
narrow-angle glaucoma or urinary retention. Instruct patients to
consult a physician immediately should any signs or symptoms of
narrow-angle glaucoma or prostatic hyperplasia or bladder-neck
obstruction develop.
Immediate hypersensitivity reactions may occur after
administration of Tudorza. If such a reaction occurs, therapy with
Tudorza should be stopped at once and alternative treatments
considered. Patients with a history of hypersensitivity reactions
to atropine should be closely monitored for similar
hypersensitivity reactions to Tudorza. Use with caution in patients
with severe hypersensitivity to milk proteins.
About Almirall
Almirall is an international pharmaceutical company based on
innovation and committed to health. Headquartered in Barcelona, it researches, develops,
manufactures and commercialises its own R&D and licensed drugs
with the aim of improving people's health and wellbeing. Almirall
focuses its research resources on respiratory, gastrointestinal,
dermatology and pain. Almirall's medicines are currently present in
over 70 countries in the five continents. It has direct presence in
Europe and Mexico through 12 affiliates.
For further information please visit:
http://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
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 Reports on Form
10-Q, and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this rerelease to
reflect new information or future events or developments.