AzorTreatment for Hypertension
Update: Azor Now FDA Approved - September 26, 2007
Daiichi Sankyo and Forest Laboratories Sign Letter of Intent for Co-Promotion of Azor
PARSIPPANY, N.J. and NEW YORK, August 21, 2007, 2007 /PRNewswire/ -- Daiichi Sankyo, Inc. and Forest Laboratories, Inc. announced today that they have signed a Letter of Intent to enter into a definitive co-promotion agreement in the United States for Azor, 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 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. Our existing arrangement with Forest on Benicar (olmesartan medoxomil) and Benicar HCT (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, 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 in 2001. During the ensuing years we have fostered a strong relationship and believe that the agreement for Azor 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)
Azor 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 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 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 www.dsus.com.
About Forest Laboratories and Its Products
Forest Laboratories (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 (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and generalized anxiety disorder; Namenda (memantine HCl), an N-methyl D- aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; and Campral* (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* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar HCT (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)www.americanheart.org (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
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Posted: August 2007
- Azor Receives FDA Approval as First-Line Treatment for High Blood Pressure - May 13, 2009
- Daiichi Sankyo, Inc. Files Supplemental New Drug Application for Azor as Initial Therapy for High Blood Pressure - September 17, 2008
- Azor Receives FDA Approval for Treatment of High Blood Pressure - September 27, 2007
- Daiichi Sankyo, Inc. Announces Filing of NDA for Amlodipine Besylate / Olmesartan Medoxomil Combination for the Treatment of Hypertension - November 28, 2006