NEW YORK and BARCELONA, Spain, April 10 /PRNewswire-FirstCall/ --
Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest
Laboratories, Inc. (NYSE: FRX) and Almirall, a privately held
pharmaceutical company headquartered in Barcelona, Spain, announced today
that the two companies have entered an agreement to develop, market and
distribute Almirall's novel inhaled, long-acting muscarinic antagonist,
LAS34273, in the United States.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The innovative LAS34273 is now entering Phase III studies in the United
States and Europe for chronic obstructive pulmonary disease (COPD).
LAS34273 has been evaluated in Phase II studies that demonstrate that it
has a fast onset of action and provides 24 hours of bronchodilation. LAS
34273 is designed to have a very specific action in the lungs resulting in
a low level of systemic exposure. Studies to date including cardiovascular
safety studies support a favorable side effects profile. The product is
being developed in a Multi Dose-Dry Powder Inhaler (MDPI) which represents
an improvement in drug delivery over currently available devices.
This new treatment promises to provide relief for the many sufferers of
COPD. According to the World Health Organisation, COPD is the 5th leading
cause of death worldwide and the fourth in the US. Affecting over 12
million adults in the US, it is also estimated that a further 24 million
show some evidence of impaired lung function highlighting a clear under
diagnoses of COPD.(1) The condition, which is mainly caused by smoking,
results in damage to the airways which triggers symptoms such as cough,
breathlessness, excess sputum and chest infections.
Under terms of the agreement, Forest will make an upfront payment of
$60 million to Almirall and will pay future undisclosed milestone payments.
In addition, Almirall will receive royalty payments based on LAS34273
sales. Forest and Almirall will jointly oversee the development and
regulatory approval of LAS34273 and share all expenses for current and
future development programs. Almirall has granted Forest the rights of
first negotiation for other Almirall respiratory products that could be
combined with LAS34273.
Forest will be responsible for sales and marketing of LAS34273 in the
US and Almirall has retained an option to co-promote the product in the
future while retaining commercialization rights for the rest of the world.
In addition to five years of Hatch-Waxman exclusivity granted upon
approval, LAS34273 is protected by an issued US composition of matter
patent expiring in 2020. Extension of exclusivity under Hatch-Waxman
legislation is expected.
Howard Solomon, Chairman and Chief Executive Officer of Forest
commented: "We are very pleased to be entering into this partnership with
Almirall, which is the largest and a highly successful independent
pharmaceutical company in Spain. We expect LAS34273 to become an important
product in the treatment of COPD, a major respiratory disease that affects
over 12 million people in the United States and is the nation's fourth
leading cause of death. We have been very impressed by the clinical profile
of the drug based on the Phase II study results as well as its convenient
inhalation delivery system. LAS34273 is another later stage product that
augments our growing pipeline and validates again our unique position and
our business strategies."
"We are very pleased to be working with Forest to launch LAS34273 into
the fast growing COPD market", said Dr. Jorge Gallardo, Chairman and Chief
Executive Officer of Almirall. "Through this agreement we will collaborate
with a strong and experienced partner who has a successful track record in
building successful brands in the United States. We are confident that this
will be a successful partnership leveraging Forest's proven skills in
clinical development and marketing in the competitive US market. Both
companies believe LAS34273 is a compelling product that has promising
potential to become a leading treatment for patients suffering from COPD."
(1) American Lung Association
About Forest Laboratories
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated
for adults for the initial and maintenance treatment of major depressive
disorder and for generalized anxiety disorder; Namenda(R) (memantine HCl),
an N-methyl- D-aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker, and Benicar*
HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor
blocker and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities 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 the Forest
Laboratories' SEC reports, including the Company's Annual Report on Form
10-K for the fiscal year ended March 31, 2005, and on form 10-Q for the
periods ended June 30, September 30, 2005 and December 31, 2005.
About Almirall
Almirall is an international pharmaceutical company that researches,
develops and commercialises its own R&D and licensed specialties with the
aim of improving health and quality of life. Almirall research products
include AXERT9(R) (Almotriptan) for the treatment of migraine which was
approved by the FDA in 2001 and is marketed by Ortho-McNeil, a division of
Johnson & Johnson.
Almirall is to invest 750 million euros in R&D over the next five
years. Almirall, whose headquarters are in Barcelona (Spain), has a staff
of over 3,200 people, approximately 500 of whom work in R&D and with
approximately 1000 working internationally in Almirall affiliate companies.
The therapeutic areas on which Almirall focuses its research resources
are related to the treatment of COPD, asthma, psoriasis and rheumatoid
arthritis. Almirall is currently present in approximately 100 countries
with its own products and licensed products from other companies. The
company is strengthening its direct presence in Europe and Latin America
via affiliates in France, Germany, Italy, Portugal, Belgium and Mexico.
For more information: http://www.almirall.es
About COPD
COPD is the 4th leading cause of death in the U.S. and is projected to
be the 3rd leading cause of death for both men and women by 2020. In 2000
about 119.000 deaths in the US were due to COPD and in 2002 $18 billion
direct cost and 14 billion indirect costs were caused by COPD. Data from
National Heart Blood and lung Institute COPD fact sheet.
(http://www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf)
SOURCE Forest Laboratories, Inc.; Almirall
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Related links:
http://www.frx.com
http://www.almirall.es
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
CONTACT:
Charles E. Triano, Vice President-Investor
Relations, Forest Laboratories, Inc., +1-212-224-6714,
charles.triano@frx.com; Carla Cudos, carla.cudos@ketchum.com or
Victoria Hernandez, victoria.hernandez@ketchum.com, both of
Ketchum/SEIS, for Almirall, +34-91-788-32-00
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