Forest Laboratories and Almirall announce commercial availability of Tudorza™ Pressair™ in US pharmacies
NEW YORK & BARCELONA, Spain--(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
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
for more information 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 FEV at 12 weeks (the primary endpoint) and 24 weeks
compared to placebo. Mean peak improvements in lung function (FEV)
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
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.
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 peoples 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.
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. Forests
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
Forest Laboratories, Inc.Frank J.
Murdolo, 212-224-6714Vice President - Investor Relationsmedia.firstname.lastname@example.org
San Segundo, email@example.comInvestor
Relations:AlmirallJordi Molina, firstname.lastname@example.org
Source: Forest Laboratories, Inc.