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.
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
|SOURCE Daiichi Sankyo, Inc.; Forest Laboratories|
Copyright©2007 PR Newswire.
All rights reserved