Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of AZOR(TM)
August 21 2007 - 7:58AM
PR Newswire (US)
PARSIPPANY, N.J. and NEW YORK, Aug. 21, 2007 /PRNewswire/ --
Daiichi Sankyo, Inc. and Forest Laboratories, Inc. (NYSE:FRX)
announced today that they have signed a Letter of Intent to enter
into a definitive co-promotion agreement in the United States for
AZOR(TM), a fixed-dose combination of two antihypertensives, the
calcium channel blocker amlodipine besylate and the angiotensin
receptor blocker olmesartan medoxomil. Daiichi Sankyo filed a New
Drug Application (NDA) in November 2006 for the fixed-dose
combination of the two antihypertensives. This investigational
agent is currently under regulatory review in the United States by
the Food and Drug Administration, including trade name review, with
a decision anticipated by late September. "The signing of the
Letter of Intent with Forest to co-promote AZOR(TM) provides us
with important additional resources to support this product as we
continue to increase the size of our own sales force," said Joseph
P. Pieroni, President and CEO, Daiichi Sankyo. "The additional
resources allow us to realize the full potential of AZOR(TM). Our
existing arrangement with Forest on Benicar(R) (olmesartan
medoxomil) and Benicar HCT(R) (olmesartan medoxomil-
hydrochlorothiazide) is nearing the end of its active co-promotion
term. This relationship has been a very successful one for both
companies, and we are pleased to begin a new arrangement with our
valued partner." Under the terms of the Letter of Intent, Forest
will pay Daiichi Sankyo an upfront payment of $20 million. Forest
will enter into a co-promotion arrangement in the U.S., providing
an agreed minimum number of product details, and will receive an
annual co-promotion payment based upon U.S. product net sales.
Daiichi Sankyo will record product sales and bear all marketing and
development expenses for the product during the term of the
agreement. The amount of Forest's payment will be determined by
annual sales levels of AZOR(TM), with Forest eligible to receive
higher levels of payment based upon the product achieving
undisclosed pre-specified sales targets in the U.S. The term of the
agreement is six years. Forest and Daiichi Sankyo will co-promote
the product during the first three years of promotion followed by a
three-year period of residual payments to Forest from Daiichi
Sankyo during which Forest will no longer co-promote the product.
Additional financial terms were not disclosed. Howard Solomon,
Chairman and Chief Executive of Forest, commented: "We are pleased
to build upon a successful partnership with Daiichi Sankyo that
began with our initial co-promotion agreement for Benicar(R) in
2001. During the ensuing years we have fostered a strong
relationship and believe that the agreement for AZOR(TM) will only
further the strength and the success of the partnership."
Hypertension, also known as high blood pressure, affects
approximately 72 million people in the United States and
approximately one billion worldwide.(1),(2) It is often difficult
to control, and of those diagnosed with high blood pressure, 64.9
percent do not have the condition under control.(1) The number of
people with high blood pressure is expected to reach about 1.6
billion worldwide by 2025.(3) About AZOR(TM) AZOR(TM) is a
fixed-dose combination of two antihypertensives, the calcium
channel blocker amlodipine besylate and the angiotensin receptor
blocker olmesartan medoxomil. The results of a Phase III
registration trial for AZOR(TM) were presented for the first time
in May at a late breaker session at the American Society of
Hypertension (ASH 2007) meeting in Chicago. AZOR(TM) was shown to
produce significant mean reductions in seated systolic and
diastolic blood pressure in patients with hypertension. Amlodipine
10mg/day plus olmesartan 40mg/day reduced systolic blood pressure
an average of 30.1 mm Hg and the diastolic reading an average of
19.0 mm Hg. These results were in comparison with mean reductions
of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10mg
alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10mg
alone, amlodipine 10mg/day plus olmesartan 40 mg/day resulted in a
53 percent greater reduction in systolic blood pressure. Amlodipine
combined with olmesartan provides two complementary mechanisms of
action to lower blood pressure: calcium channel blockade with
amlodipine and angiotensin receptor blockade with olmesartan. The
adverse event profile for each of the combinations was similar in
nature to the monotherapy components. Most reported
treatment-emergent adverse events across all treatment groups were
considered mild in severity. About Daiichi Sankyo, Inc. Daiichi
Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S.
subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest
pharmaceutical company and a global leader in pharmaceutical
innovation since 1899. The company is dedicated to the discovery,
development and commercialization of innovative medicines that
improve the lives of patients throughout the world. The primary
focus of Daiichi Sankyo's research and development is
cardiovascular disease, including therapies for dyslipidemia,
hypertension, diabetes and acute coronary syndrome. The company is
also pursuing the discovery of new medicines in the areas of
glucose metabolic disorders, infectious diseases, cancer, bone and
joint diseases and immune disorders. For more information, visit
http://www.dsus.com/. About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com/) is a U.S.-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 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; 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. In addition to our growing product line, Forest also
co-promotes the Daiichi Sankyo, Inc. products 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. *Benicar is a
registered trademark of Daiichi Sankyo, 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 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 the Forest Laboratories' SEC reports,
including the Company's Annual Report on Form 10-K for the fiscal
year ended March 31, 2007. (1)
http://www.americanheart.org/presenter.jhtml?identifier=4621 (2)
Chobanian AV, Bakris GL, Black HR et al. The Seventh Report of the
Joint National Committee on Prevention, Detection, Evaluation, and
Treatment of High Blood Pressure. JAMA. 2003;289:2560-2572 (3)
Kearney PM, et al. Global burden of hypertension: analysis of
worldwide data. Lancet 2005, 365:217-23 DATASOURCE: Daiichi Sankyo,
Inc. CONTACT: Jo-ann Straat of Daiichi Sankyo, +1-973-359-2602, ;
or Charles E. Triano of Forest Laboratories, +1-212-224-6714, Web
site: http://www.dsus.com/ http://www.frx.com/
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