Almirall and Forest Announce Positive Results from the ATTAIN Phase III Study of Aclidinium Bromide and the Phase IIb Studies With the Fixed Dose Combination with Formoterol in Moderate to Severe COPD Patients

By Forest Laboratories Inc., PRNE
Monday, January 3, 2011

BARCELONA and NEW YORK, January 4, 2011 -

    - ATTAIN results confirm clinically significant
      bronchodilation and improvement ofsymptoms in COPD patients treated
      with aclidinium bromide twice daily

    - Regulatory filings in Europe and USA for aclidinium bromide
      monotherapy are planned for mid 2011

    - Positive results of two Phase IIb studies with the fixed
      dose combination of aclidinium bromide and formoterol will enable Phase
      III to start in second half 2011

Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE:
FRX) today announced positive top-line results of ATTAIN, a six month
double-blind placebo-controlled pivotal Phase III study comparing the
efficacy and safety of inhaled aclidinium bromide 200 micrograms and 400
micrograms twice daily (BID) versus placebo, in 828 patients with moderate to
severe COPD.

Aclidinium 200 micrograms and 400 micrograms produced
statistically significant increases from baseline in morning pre-dose
(trough) FEV1 versus placebo at week 24 (99mL and 128mL, respectively;
p<0.0001), which was the primary endpoint of the study for Europe, and at
week 12 (77mL and 105mL, respectively; p<0.0001) which was the primary
endpoint for the US.

All secondary endpoints demonstrated statistically significant
differences vs placebo for both doses. These endpoints included peak FEV1,
and the percentage of patients achieving a clinically meaningful reduction in
breathlessness (assessed by a 1 unit improvement in Transition Dyspnea Index)
and the percentage of patients with improved health status (assessed by a
4-unit improvement in the St. George's Respiratory Questionnaire).

Additionally, throughout the entire study, aclidinium produced
statistically significant changes from baseline in trough FEV1 vs placebo at
each time-point, which ranged from 77mL to 105mL for aclidinium 200
micrograms and from 105mL to 140mL for aclidinium 400 micrograms.

Aclidinium was well tolerated in this study. The incidence of
adverse events and serious adverse events was similar across the three study
treatment arms.

"We are very pleased with these results which demonstrate that
aclidinium provided consistent bronchodilation and symptom control in COPD
for patients suffering from this debilitating disease", said Jorge Gallardo,
Chairman and Chief Executive Officer at Almirall. "With these results, we
anticipate regulatory filings for aclidinium BID monotherapy this year".

Regulatory submissions in Europe and the US for aclidinium
bromide monotherapy are both planned for mid 2011.

Aclidinium and formoterol fixed dose combination Phase IIb
Studies

Two Phase IIb dose-ranging studies comparing fixed-dose
combinations (aclidinium bromide/ formoterol) to aclidinium bromide alone,
formoterol alone and placebo, administered BID in patients with stable
moderate to severe COPD, have also been successfully completed. Both studies
showed statistically significant (p<0.001) differences for the fixed dose
combination 2 on the primary endpoint versus placebo (normalized AUC 0-12
hours FEV1). The fixed dose combinations provided improved bronchodilation
compared to aclidinium and formoterol alone. Following regulatory
consultations, Phase III with the fixed dose combination will commence in the
second half of 2011.

"Together with our partner Almirall, we are delighted with the
ATTAIN results which confirm the efficacy reported in the ACCORD COPD I
study. We are also encouraged by the results achieved with the fixed dose
combination of aclidinium and formoterol in the Phase IIb studies, a
combination of two bronchodilators, each with a different mode of action. We
believe that aclidinium, a proprietary long-acting inhaled muscarinic
antagonist, and formoterol, a long-acting inhaled beta agonist may be a
desired combination for the treatment of COPD," said Howard Solomon Chairman
and Chief Executive Officer of Forest Laboratories.

About ATTAIN Phase III study

ATTAIN (Aclidinium To Treat Airway obstruction In COPD
patieNts) was conducted in Europe and South Africa. It was a 24 week study,
which assessed the long term bronchodilator efficacy and safety of inhaled
aclidinium bromide 200 micrograms and 400 micrograms, both administered BID,
compared to placebo in 828 moderate to severe COPD patients (mean baseline
FEV1= 1480mL).

In addition, it assessed the benefits of aclidinium bromide
200 micrograms and 400 micrograms, compared to placebo, in disease-related
health status and COPD symptoms.

Aclidinium 200 micrograms and 400 micrograms produced
statistically significant increases from baseline in morning pre-dose
(trough) FEV1 versus placebo at week 24 (99mL and 128mL, respectively;
p<0.0001), which was the primary endpoint of the study for Europe, and at
week 12 (77mL and 105mL, respectively; p<0.0001) which was the primary
endpoint for the US.

Aclidinium also demonstrated statistically significant
improvement vs placebo on the three secondary endpoints assessed in the
study:

    - Changes from baseline in peak FEV1 observed after morning
      dosing with 200 micrograms or 400 micrograms of aclidinium at weeks 12
      and 24 (p<0.0001 for both doses at both time points).

    - Percentage of patients experiencing a clinically meaningful
      improvement of greater than or equal to 1-unit from baseline in
      shortness of breath at week 24, as measured by the Transition Dyspnea
      Index (TDI), (p=0.032 for aclidinium 200 micrograms; p=0.004 for
      aclidinium 400 micrograms).

    - Percentage of patients achieving a clinically meaningful
      improvement of greater than or equal to 4-units from baseline in health
      related quality of life, as measured by the St. George's Respiratory
      Questionnaire (SGRQ) at week 24 (p=0.0004 for aclidinium 200
      micrograms; p=0.0014 for aclidinium 400 micrograms).

Additionally, throughout the entire study, aclidinium produced
statistically significant changes from baseline in trough FEV1 vs placebo at
each time-point, which ranged from 77mL to 105mL for aclidinium 200
micrograms and from 105mL to 140mL for aclidinium 400 micrograms.

Aclidinium was well tolerated in this study. The percentage of
patients reporting adverse events and serious adverse events was similar in
the placebo, 200 micrograms and 400 micrograms treatment arms. The most
common adverse events (higher than 5% and reported more frequently with
aclidinium than placebo) were headache and nasopharyngitis. Also, the
incidence of anticholinergic adverse events was low and comparable to
placebo (e.g. dry mouth and constipation were both <1%).

Endpoint Definitions

    - FEV1 - Forced expiratory volume in one second, or the amount
      of air that can be exhaled in the first second, following an
      inhalation.

    - Morning pre-dose (trough) FEV1 - average of two FEV1
      measurements within 1 hour before morning treatment administration.

    - Normalized AUC (0-12 hours) FEV1 - Average area under the
      FEV1 curve over 12 hours, from dosing in the morning until pre-dose
      twelve hours later (0-12 hours).

About aclidinium bromide and the Genuair(R) inhaler

Aclidinium bromide is a novel, long-acting inhaled
anticholinergic bronchodilator which has a long residence time at the M3
receptors and a shorter residence time at the M2 receptors. Aclidinium is
rapidly hydrolyzed in human plasma to two major inactive metabolites. Forest
Laboratories, Inc. licensed US rights for aclidinium from Almirall, while
Almirall maintains rights for the rest of the world. The companies are
jointly involved in the development of the compound.

Aclidinium bromide is administered to patients using a novel,
investigational, state-of-the-art multidose dry powder inhaler (MDPI),
Genuair(R). The Genuair(R) inhaler was designed with a feedback system, which
through a 'colored control window' and an audible click helps confirm that
the patient has inhaled correctly. It contains multiple doses of aclidinium,
includes a visible dose-level indicator and also incorporates safety features
such as an antidouble- dosing mechanism and an end-of-dose lock-out system to
prevent use of an empty inhaler. Genuair(R) is a registered trademark owned
by Almirall, S.A.

About COPD

The World Health Organization (WHO) has described COPD as a
global epidemic; an estimated 210 million people have COPD worldwide and 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.

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 a 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. There are significant unmet needs in the
treatment of COPD including limited therapeutic options to improve lung
function, reduce symptoms and control exacerbations.

About Almirall

Almirall is an international pharmaceutical company based on
innovation and committed to health. Headquartered in Barcelona, Spain, it
researches, develops, manufactures and commercializes its own R&D and
licensed drugs with the aim of improving people's health and wellbeing.

Almirall focuses its research resources on therapeutic areas
related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary
Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other
dermatological conditions.

Almirall's products are currently present in over 70 countries
while it has direct presence in Europe and Latin America through 12
affiliates.

For further information please visit the website at:
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 medicine. The Company'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.

Almirall media contacts: Annabel Gillett, Ketchum Pleon, +44-(0)-207.611.3559,
annabel.gillett at ketchumpleon.com, Forest contacts: Frank J. Murdolo, Vice President - Investor Relations, Forest Laboratories, Inc, +1-212-224-6714, Frank.Murdolo at frx.com

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