Sankyo Pharma Inc. Announces Its Second Cardiovascular Product

 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. 
 
 
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