Sankyo Pharma Submits Supplemental New Drug Application For New
Combination Benicar HCT(TM) (Olmesartan
Medoxomil-Hydrochlorothiazide) For The Treatment Of Hypertension
PARSIPPANY, NJ -- (INTERNET WIRE) -- 08/20/02 -- Sankyo Pharma Inc.
has filed a supplemental new drug application (sNDA) with the U.S.
Food and Drug Administration (FDA) for its combination therapy drug,
Benicar HCT(TM) (olmesartan medoxomil-hydrochlorothiazide) for the
treatment of hypertension. Benicar(TM) (olmesartan medoxomil) was
approved by the FDA in April of this year and is available now.
Benicar is co-promoted by Sankyo Pharma and Forest Laboratories, Inc.
Benicar HCT will join the angiotensin II receptor blocker (ARB)
combination product category, one of the fastest-growing segments of
the rapidly-growing ARB category of antihypertensives. In the last
12 months, ARB combination product sales have increased 33%(1).
Benicar effectively lowers diastolic and systolic blood pressure in
patients who suffer from hypertension, and 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 * and diastolic blood pressure by an average of 12 mm Hg(2).
With hypertension, it is important to achieve optimal blood pressure
control. The Joint National Committee on Prevention, Detection,
Evaluation and Treatment of High Blood Pressure, coordinated by the
National Heart, Lung and Blood Institute, recommends a blood pressure
goal of below 140/90(3).
In two scientifically comprehensive studies, Benicar demonstrated
superior blood pressure-lowering efficacy over ARB market leader
Cozaar(R) (losartan potassium). The first study, published in the
Journal of Clinical Hypertension (September/October 2001), showed a
significantly greater reduction in both cuff systolic and diastolic
blood pressure using the starting doses of both drugs, Benicar 20 mg
daily versus Cozaar 50 mg daily, after 8 weeks of therapy.
Benicar(TM) (olmesartan medoxomil) was also significantly more
effective than Cozaar in reducing average systolic and diastolic
blood pressure as measured by 24-hour ambulatory monitoring, the most
sensitive and objective technique available(4).
In the second study, patients receiving Benicar up to 20 mg daily
achieved a significantly greater reduction of average systolic and
diastolic blood pressure than those taking Cozaar up to 100 mg once a
Benicar demonstrated numerically greater, although not statistically
different, reductions in both cuff and ambulatory systolic and
diastolic blood pressure when compared to the most widely prescribed
antihypertensive agent, Norvasc(R) (amlodipine besylate)(6) ,
according to a head-to-head, starting dose study presented at the
American Society of Hypertension's 17th annual scientific meeting.
When blood pressure control rates were assessed, based on ambulatory
diastolic blood pressure, Benicar(TM) (olmesartan medoxomil) and
Norvasc(R) (amlodipine besylate) were similar in terms of percentage
of patients achieving a blood pressure goal of < 90 mm Hg. However,
Benicar was significantly better than Norvasc in achieving the more
rigorous ambulatory DBP control target of < 85 mm Hg (48% vs.
Angiotensin II is a potent vasoconstrictor that increases blood
Benicar works by blocking angiotensin II receptors in blood vessels,
resulting in lower systolic and diastolic blood pressure. In clinical trials,
Benicar demonstrated a side-effect profile similar to placebo. The
only side effect that occurred in more than 1 percent of patients
treated with Benicar and at a higher incidence versus placebo was
dizziness (3% vs. 1%). Benicar, like all members of the ARB class,
is not recommended for pregnant women.
Benicar also has a favorable drug-drug interaction profile. No
significant drug interactions were reported in studies in which
Benicar was co-administered with digoxin or warfarin. In addition,
Benicar is not metabolized by the cytochrome P450 enzyme system, so
interactions with drugs that inhibit, induce or are metabolized by
that system are not expected. Benicar is also convenient, since it
can be taken with or without food.
Hypertension, also known as high blood pressure, is called the "silent
killer" because it has no specific symptoms and increases the risk of
cardiovascular and related diseases such as stroke, heart attack,
heart and kidney failure(8).
Today, an estimated 50 million Americans suffer from hypertension; more
than 30 percent are unaware that they have high blood pressure(9)
and approximately three-quarters of those being treated are not
reaching the recommended goal(10).
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,
Benicar should be discontinued as soon as possible. See WARNINGS,
Fetal/Neonatal Morbidity and Mortality.
Sankyo Pharma Inc. is dedicated to developing and marketing important
pharmaceutical products for the U.S. market. Sankyo Pharma has
offices in New York and New Jersey with a research institute in
California. A national sales force of 550 representatives promotes
Sankyo Pharma products, and they are supported by dedicated managed
care and field-based medical personnel.
In addition to Benicar, Sankyo Pharma launched WelChol(R)(colesevelam
HCI), a non-systemic lipid-lowering agent, in September 2000. 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.
Sankyo Pharma also markets and distributes the GlucoWatch(R)
Biographer, the first and only monitoring system to provide glucose
readings automatically and non-invasively. The GlucoWatch(R)
Biographer is manufactured by Cygnus, Inc.
Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is Japan's
second largest pharmaceutical company with annual worldwide sales of
$4.5 billion. Sankyo Pharma 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 to be marketed.
Additionally, Sankyo discovered, co-developed and manufactures
pravastatin sodium. Sankyo independently markets pravastatin
throughout the world and through its licensee, Bristol-Myers Squibb
Co. Pravastatin is marketed as Pravachol(R) in the United States.
Forest Laboratories, Inc. develops, manufactures and markets branded
and generic pharmaceutical products in the United States.
Forest's principal products, which are marketed directly by the
Company, include Celexa(TM) (citalopram HBr), a selective serotonin
reuptake inhibitor (SSRI) for the treatment of depression; Tiazac(R)
(diltiazem HCl), a once daily calcium channel blocker for treating
hypertension and angina; Aerobid(R) (flunisolide), a metered dose
inhaler for treating asthma; and Infasurf(R) (calfactant), a lung
surfactant to treat respiratory distress in infants.
The Company's current product pipeline includes: Escitalopram the
single isomer form of Celexa; flunisolide HFA for asthma; Memantine,
for the treatment of Alzheimer's Disease and neuropathic pain
licensed form Merz + Co; Lercanidipine, licensed from Recordati,
S.p.A., for the treatment of hypertension; Dexloxiglumide, licensed
from Rotta Research Laboratorium S.p.A., for the treatment of
constipation-prone irritable bowel syndrome; and Neramexane, licensed
from Merz + Co, for the treatment of various CNS disorders.
*mm Hg = millimeters of mercury -- the standard for measuring blood
(1)IMS National Prescription Audit, June 2002.
(2)Data on file.
(3)Sixth Report of the Joint National Committee on Detection,
Evaluation and Treatment of High Blood Pressure (JNC VI). Bethesda,
Md: National Institute of Health: National Heart, Lung and Blood
Institute; National High Blood Pressure Education Program; November
(4)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.
(5)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.
(6)Data on File.
(7)Data on File.
(8)Preliminary estimate from The Nation Health and Nutrition
Examination Survey (NHANES III) (1988-91) CHC/NCHS.
Norvasc(R) is a registered trademark of Pfizer Inc.; Cozaar(R) is a
registered trademark of Merck & Co.; Pravachol(R) is a registered
trademark of Bristol-Myers Squibb Co.
Please see full prescribing information.
Contact: Deborah Adams, Hill and Knowlton
Contact: Wendy Lu, Hill and Knowlton
Provider ID: 09045565
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