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Forest Laboratories and Almirall announce commercial availability of Tudorza™ Pressair™ in US pharmacies

  Forest Laboratories and Almirall announce commercial availability of
  Tudorza™ Pressair™ in US pharmacies

            New treatment for COPD now available in US pharmacies

Business Wire

NEW YORK & BARCELONA, Spain -- December 11, 2012

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 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

Tudorza provides statistically significant improvements in bronchodilation, as
measured by change from baseline in morning pre-dose trough FEV[1] at 12 weeks
(the primary endpoint) and 24 weeks compared to placebo. Mean peak
improvements in lung function (FEV[1]) 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

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.


  * 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
  * 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:

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

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.


Contact Forest:
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
Contact Almirall:
Media information:
Sonia San Segundo, 00-34-91-788-32-00
Investor Relations:
Jordi Molina, 00-34-93-291-30-87
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