Launch Business Editors PARSIPPANY, N.J.--(BUSINESS WIRE)--April 26, 2002--Sankyo Pharma: FDA Grants Marketing Approval to Benicar(TM) (olmesartan medoxomil) for Treatment of Hypertension Sankyo Pharma announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Benicar, the newest entry to the rapidly growing angiotensin II receptor blocker (ARB) class, for the treatment of high blood pressure. Benicar, which will be available in the first half of 2002, can be administered alone or in combination therapy with other antihypertensive agents. Studies have shown that Benicar 20 mg -- the usual recommended starting dose -- taken once a day, resulted in significant blood-pressure reduction, lowering systolic blood pressure by an average of 15 mm Hg(a) and diastolic blood pressure by an average of 12 mm Hg.(1) "There's a lot of interest in Benicar," said Dr. Michael Weber, professor of Medicine and associate dean of research, State University New York Downstate College of Medicine, Brooklyn, N.Y. "We know Benicar is very effective at reducing blood pressure. And reducing blood pressure, even by a couple of extra points as compared with several existing blood pressure medications, may be important in reducing patients' risks of strokes, heart attacks and kidney disease." Additional studies have shown that Benicar demonstrated superior blood pressure lowering efficacy over ARB market leader Cozaar(R) (losartan potassium).(2)(3) "We are happy to introduce Benicar as the newest addition to our growing line of quality cardiovascular products," said Joseph P. Pieroni, President of Sankyo Pharma Inc. "In this disease category, there's a need for continuous innovation and improvement. Benicar is a new treatment option that can help patients achieve their blood-pressure goals. And from a corporate perspective, it is another example of our commitment to expand in the U.S. market." Benicar(TM), discovered and developed by Sankyo, is the second in a line of cardiovascular products that the company launched and the third product that it will market. In September 2000, Sankyo Pharma launched WelChol(R) (colesevelam hydrochloride) for the treatment of hypercholesterolemia. In less than 12 months after launch, WelChol vaulted to the number one position in its class, with first full-year sales exceeding $90 million in 2001. In addition, Sankyo is co-promoting the GlucoWatch(R) Biographer -- the only glucose monitor to provide readings automatically and non-invasively -- with Cygnus, Inc. Sankyo Pharma has selected Forest Laboratories as a long-term partner to co-promote Benicar (olmesartan medoxomil) to primary care physicians, cardiologists and nephrologists throughout the country. This partnership will increase the sales force that promotes Benicar to over 1,200. Today, an estimated 50 million Americans suffer from hypertension; more than 30 percent are unaware that they have high blood pressure(4), and approximately three-quarters of those being treated are not reaching the recommended goal of 140/90.(5) Sankyo Pharma is increasing its presence in the U.S. with new, advanced cardiovascular products, and is also growing in the diabetes category with a number of products in its pipeline. Recently, Sankyo announced that it has entered into a partnership with MDS Pharma Services, a part of MDS Inc. (NYSE: MDZ; TSE:MDS), in which MDS will build and manage a Clinical Pharmacology Unit exclusively for Sankyo Pharma's clinical development division. About Sankyo Sankyo Pharma is dedicated to developing and marketing important pharmaceutical products for the U.S. market. The company has offices in New York and New Jersey, and a research institute in California. Sankyo Pharma's parent company, Sankyo Co., Ltd. of Tokyo, is Japan's second largest pharmaceutical company with annual worldwide sales of $4.3 billion. Sankyo has a long history of discovering new classes of drugs, including the statin class of lipid lowering drugs with its discovery of the first statin, mevastatin, and the co-discovery of lovastatin, the first statin therapy to be marketed. Additionally, Sankyo discovered, co-developed and manufactures pravastatin. Sankyo independently markets pravastatin throughout the world and through its licensee, Bristol-Myers Squibb. Pravastatin is marketed as Pravachol(R) in the United States. Detailed information about Sankyo Pharma is available at www.sankyopharma.com. Cozaar(R) is a registered trademark of Merck & Co.; Pravachol(R) is a registered trademark of Bristol-Myers Squibb, Co. (a) mm Hg = millimeters of mercury of blood pressure -- the standard for measuring blood pressure. (1) Data on file. (2) Oparil S. Williams D, Chrysant, S, Marbury, T, Neutel, J. Comparative Efficacy of Olmesartan, Losartan, Valsartan, and Irbesartan in the control of essential hypertension. Journal of Clinical Hypertension. 2001;3:283-291. (3) Ball K. A Multi-centre, Double-blind, Efficacy, Tolerability and Safety Study of the Oral Angiotensin II-Antagonist Olmesartan Medoxomil Versus Losartan in Patients with Mild to Moderate Essential Hypertension. J Hypertens. 2001;19 (suppl 2): S153. (4) Preliminary estimate from The Nation Health and Nutrition Examination Survey (NHANES III) (1988- 91) CHC/NCHS. (5) JNC VI.
Sankyo Pharma Inc. Announces Its Second Cardiovascular Product
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