Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of
Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM.MC)
today announced that they have entered an agreement to develop,
market and distribute LAS100977 in the United States. LAS100977 is
an inhaled, once-daily administered long-acting beta2 agonist
(LABA) that until now has been developed by Almirall to treat
bronchoconstriction in asthmatic patients. Forest and Almirall will
develop LAS100977 in combination with an undisclosed corticosteroid
using Almirall’s proprietary GENUAIR® inhaler for the
treatment of both asthma and Chronic Obstructive Pulmonary Disease
(COPD).
Under the terms of the agreement, Forest will make an upfront
payment to Almirall of $75 million and will pay future, undisclosed
milestone payments and sales based royalty payments. Forest will
assume responsibility for the United States regulatory approval and
commercialization.
"We are very pleased with this new agreement. Extending our
collaboration with Forest is an excellent opportunity to maximize
the value of LAS100977 for patients and investors," said Jorge
Gallardo, Chairman and Chief Executive Officer of Almirall. "Forest
has first class development and commercial capabilities and both
parties can leverage from the current EKLIRA® (aclidinium
bromide) collaboration to move forward these exciting respiratory
compounds. This agreement is also a milestone in our aim to offer
society innovative medicines to fulfill unmet medical needs,” he
added.
Howard Solomon, Chairman and Chief Executive Officer of Forest,
said, "We are pleased to have entered into this second major
collaboration with Almirall, one of the premier innovators in the
respiratory field. This agreement represents an exciting extension
of the strong collaboration established with aclidinium bromide for
COPD three years ago between Forest and Almirall and which will be
completing Phase III studies in 2010. LAS100977 has shown very
encouraging results in the completed Phase II studies, and we
believe it will be a very competitive entrant in this large drug
class. With the addition of LAS100977, Forest rounds out a broad
COPD pipeline that was recently augmented with DAXAS®
(roflumilast) and will also gain access to the larger asthma market
with a once-daily inhaled corticosteroid/LABA combination.”
About LAS100977
LAS100977 is a highly potent novel once daily LABA that in early
Phase II testing demonstrated fast onset and long-lasting (24-hour)
efficacy with a very good tolerability profile in patients with
stable asthma after multiple dosing.
With sales of over five billion dollars in the United States
generating double digit annual growth, the combination LABA/ICS
product class is one of the largest segments in the pharmaceutical
industry. A once daily LAS100977/corticosteroid combination in the
GENUAIR® device could be an attractive alternative to
currently available LABA/corticosteroid combinations delivered
twice daily.
The GENUAIR® inhaler*
LAS100977 will be developed using GENUAIR®, a novel,
state-of-the-art, multi-dose dry powder inhaler (MDPI).
GENUAIR® was designed with an intuitive click and color
feedback system which, through a colored control window and an
audible click, indicates that the patient has inhaled correctly.
The GENUAIR® inhaler incorporates significant safety
features such as a visible dose indicator, an anti-double dosing
mechanism and an end-of-dose lock-out system to prevent use of an
empty inhaler.
About Asthma1
Asthma is a chronic disease characterized by recurrent attacks
of breathlessness and wheezing, which vary in severity and
frequency from person to person. In affected individuals, symptoms
may occur several times in a day or week, and for some people
become worse during physical activity or at night.
The World Health Organization (WHO) estimates that 300 million
people suffer from asthma and 255,000 people died of asthma in
2005. It is an under-diagnosed and under-treated disease that
creates a substantial burden to individuals and families and
possibly restricting individuals’ activities for a lifetime.
About COPD
COPD is not one single disease but an umbrella term used to
describe chronic lung diseases that cause limitations in lung
airflow including 'chronic bronchitis' and 'emphysema.' 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.
COPD is preventable but not curable, although treatment can slow
the progress of the disease. The airflow limitation is usually
progressive and associated with an abnormal inflammatory response
of the lungs to noxious particles or gases. COPD has a significant
impact on quality of life for patients and their families and WHO
estimates that 210 million people suffer from COPD and predicts
that this disease will become the third leading cause of death
worldwide by 20302.
About Almirall
Almirall is an international pharmaceutical company based on
innovation and committed to health, headquartered in Barcelona,
Spain. The company researches, develops, manufactures and
commercializes its own R&D and licensed medicines with the aim
of improving people’s health and wellbeing.
The therapeutic areas on which Almirall focuses its research
resources are related to the treatment of asthma, COPD (Chronic
Obstructive Pulmonary Disease), rheumatoid arthritis, multiple
sclerosis, psoriasis and other dermatology indications.
Almirall’s products are currently present in over 70 countries
while it has direct presence in Europe and Latin America through 11
affiliates.
For further information: www.almirall.com
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical
company with a long track record of building partnerships and
developing and marketing products that make a positive difference
in people's lives. In addition to its well-established franchises
in therapeutic areas of the central nervous and cardiovascular
systems, Forest's current pipeline includes product candidates in
all stages of development and across a wide range of therapeutic
areas. The Company is headquartered in New York, NY. To learn more
about Forest Laboratories, 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 Report on Form
10-Q, and any subsequent SEC filings.
*GENUAIR® and EKLIRA® are registered trademarks of Laboratorios
Almirall, S.A and are pending approval from the appropriate
regulatory authorities.
†DAXAS® is a registered trademark of Nycomed GmbH Corporation
and is pending approval from the appropriate regulatory
authorities.
______________________________________
1 Extracted from www.who.int – Fact sheet No 307, May 2008
2 World Health Organization (WHO): Chronic obstructive pulmonary
disease (COPD), Fact Sheet 315. Website page available at:
http://www.who.int/mediacentre/factsheets/fs315/en/
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