Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC)
announced today 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 US1. 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.
“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 commented.
“The FDA approval of TudorzaTM PressairTM 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.
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
recommend long-acting anticholinergics as a first-line therapy for
a broad range of COPD patients with moderate to very severe
disease. Tudorza will 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 1,276
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 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 (FEV1)
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
pivotal 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 how many doses
remain 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
products 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: 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. Forest assumes no obligation
to update forward-looking statements contained in this rerelease to
reflect new information or future events or developments.
1. Murphy SL et al. Deaths: Preliminary Data for 2010. National
Vital Statistics Reports. Volume 60, Number 4. January 11,
2012.
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