Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
October 12 2007 - 9:01AM
PR Newswire (US)
PARSIPPANY, N.J. and NEW YORK, Oct. 12 /PRNewswire/ -- Daiichi
Sankyo, Inc. and Forest Laboratories, Inc. (NYSE:FRX) announced
today that they have signed a contract for a co-promotion agreement
in the United States for Daiichi Sankyo's AZOR(TM), a fixed
combination of two antihypertensives, the calcium channel blocker,
amlodipine and the angiotensin receptor blocker, olmesartan
medoxomil. The companies announced a signed letter of intent for
the co-promotion agreement on August 21, 2007. Daiichi Sankyo
received U.S. Food and Drug Administration marketing approval for
AZOR on September 26, 2007. As previously announced, Forest will
make an upfront payment of $20 million to Daiichi Sankyo, which
will be made in the current quarter. About AZOR(TM) AZOR is
indicated for the treatment of hypertension, alone or with other
antihypertensive agents. AZOR is not indicated for initial therapy
of hypertension. AZOR is a convenient, once daily, single tablet
combination of amlodipine, the number one prescribed calcium
channel blocker (CCB) on the market, and olmesartan medoxomil. The
combination of these two medications will give doctors a powerful
new treatment option for patients with hypertension who need to
reduce their blood pressure levels or who are uncontrolled on other
medications. In clinical trials, AZOR produced significant mean
reductions in seated systolic and diastolic blood pressure in
patients with hypertension. According to the pivotal registrational
trial, AZOR 10/40 mg 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 10 mg alone (placebo =
4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, AZOR 10/40
mg resulted in a 53 percent greater reduction in the mean change of
systolic blood pressure. IMPORTANT SAFETY INFORMATION ABOUT AZOR
USE IN PREGNANCY When used in pregnancy during the second and third
trimesters, drugs that act directly on the renin-angiotensin system
can cause injury and even death to the developing fetus. When
pregnancy is detected, AZOR should be discontinued as soon as
possible. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity
and Mortality. In volume- and/or salt-depleted patients,
symptomatic hypotension due particularly to the olmesartan
component may occur after initiation of treatment with AZOR.
Treatment should start under close medical supervision. Patients,
particularly those with severe obstructive coronary artery disease,
may develop increased frequency, duration, or severity of angina or
acute myocardial infarction on starting calcium channel blocker
therapy. In studies of ACE inhibitors in patients with unilateral
or bilateral renal artery stenosis, increases in serum creatinine
or blood urea nitrogen (BUN) have been reported. There has been no
long-term use of olmesartan medoxomil in patients with unilateral
or bilateral renal artery stenosis, but similar effects would be
expected with AZOR because of the olmesartan medoxomil component.
Since amlodipine is extensively metabolized by the liver and the
plasma elimination half-life (t1/2) is 56 hours in patients with
severely impaired hepatic function, caution should be exercised
when administering AZOR to patients with severe hepatic impairment.
The only adverse event that occurred in greater than or equal to 3%
of patients treated with AZOR and more frequently than placebo was
edema. The placebo-subtracted incidence was 5.7% (5/20mg), 6.2%
(5/40mg), 13.3% (10/20mg), and 11.2% (10/40mg). The edema incidence
for placebo was 12.3%. Please see full prescribing information for
AZOR. 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, please visit http://www.dsus.com/.
About Forest Laboratories and Its Products 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 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 and Benicar HCT are registered trademarks
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. Jason
Ford Charles E. Triano Daiichi Sankyo Forest Laboratories (973)
359-2634 (212) 224-6714 DATASOURCE: Daiichi Sankyo, Inc.; Forest
Laboratories CONTACT: Jason Ford of Daiichi Sankyo,
+1-973-359-2634, ; Charles E. Triano of Forest Laboratories,
+1-212-224-6714, Web site: http://www.dsus.com/ http://www.frx.com/
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