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
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
Additional studies have shown that Benicar demonstrated superior
blood pressure lowering efficacy over ARB market leader Cozaar(R)
"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
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.
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
(4) Preliminary estimate from The Nation Health and Nutrition
Examination Survey (NHANES III) (1988- 91) CHC/NCHS.
(5) JNC VI.
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