Forest Laboratories and Almirall announce commercial availability of Tudorza™ Pressair™ in US pharmacies
December 11 2012 - 2:30AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC)
announced today that Tudorza™ Pressair™ (aclidinium bromide
inhalation powder) 400mcg is now available in pharmacies throughout
the United States. Tudorza is a long-acting anticholinergic
recently approved by the U.S. Food and Drug Administration (FDA)
for the long-term, maintenance treatment of bronchospasm associated
with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema.
Tudorza is the first long-acting inhaled anticholinergic
approved by the FDA in over 8 years for COPD and is administered
twice daily through the preloaded, multidose Pressair inhaler.
Almirall granted commercialization rights in the U.S. for
aclidinium to Forest Laboratories, Inc., Forest and Almirall will
co-promote aclidinium in Canada. Almirall maintains rights for the
rest of the world.
Visit www.tudorza.com for more information about Tudorza
Pressair.
About Tudorza Pressair
Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg
is an anticholinergic for the long-term, maintenance treatment of
bronchospasm associated with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and emphysema. When given by
inhalation, Tudorza produces bronchodilation by inhibiting the
muscarinic M3 receptor in the airway smooth muscle.
Tudorza provides statistically significant improvements in
bronchodilation, as measured by change from baseline in morning
pre-dose trough FEV1 at 12 weeks (the primary endpoint) and 24
weeks compared to placebo. Mean peak improvements in lung function
(FEV1) assessed after the first dose of Tudorza were similar to
those observed at week 12. Tudorza is not indicated for the initial
treatment of acute episodes of bronchospasm (ie, rescue
therapy).
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 which confirms successful inhalation of the full dose and a
dose indicator to let patients know how many doses remain in the
inhaler. For a complete description of how to use the Tudorza
Pressair inhaler and when to get a new inhaler, see the
step-by-step Instructions for Use within the Prescribing
Information.
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. As the
condition worsens and breathlessness increases, daily activities,
such as walking up a short flight of stairs or carrying a suitcase,
can become very difficult. 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 (ie, rescue
therapy).
- Inhaled medicines, including TUDORZA,
may cause paradoxical bronchospasm. In addition, immediate
hypersensitivity reactions may occur after administration of
TUDORZA. If either of these 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.
- 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.
- The most common adverse reactions (≥3%
incidence and greater than placebo) were headache (6.6% vs 5.0%),
nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for
TUDORZA and placebo, respectively.
About Almirall
Almirall is a pharmaceutical company committed to innovate
through valuable medicines. Headquartered in Barcelona, Spain, it
researches, develops, manufactures and commercialises its own
R&D and licensed drugs with the aim of improving people’s
health and wellbeing now and to future generations. Almirall
medicines, focused on respiratory, dermatology, gastrointestinal
and pain, are currently in over 70 countries while the company has
direct presence in Europe, Mexico and Canada through 13
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 release to
reflect new information or future events or developments.
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