Forest and Almirall Announce a Development and Marketing Collaboration Agreement on New Therapy for COPD
April 10 2006 - 9:00AM
PR Newswire (US)
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)
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc.; Almirall CONTACT: Charles E. Triano,
Vice President-Investor Relations, Forest Laboratories, Inc.,
+1-212-224-6714, ; Carla Cudos, or Victoria Hernandez, , both of
Ketchum/SEIS, for Almirall, +34-91-788-32-00 Web site:
http://www.frx.com/ http://www.almirall.es/
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