Combination Benicar HCT(TM) (Olmesartan medoxomil-hydrochlorothiazide) for the Treatment of Hypertension PARSIPPANY, N.J., Aug. 20 /PRNewswire/ -- 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. (NYSE: FRX). 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(1*) 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). Benicar Studies 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 day(5). 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. 34%)(7). About Benicar Angiotensin II is a potent vasoconstrictor that increases blood pressure. 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. About Sankyo 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. About Forest 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 HCI), 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 from 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. 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. (*) mm Hg = millimeters of mercury -- the standard for measuring blood pressure (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 1997. (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 National Health and Nutrition Examination Survey (NHANES III) (1988-91) CHC/NCHS. (9) Ibid. (10) JNC VI. MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X26858175 SOURCE Sankyo Pharma Inc. /CONTACT: Deborah Adams, +1-212-885-0449, or Wendy Lu, +1-212-885-0346, both of Hill and Knowlton, for Sankyo Pharma Inc./ /Web site: http://www.sankyopharma.com / (FRX) CO: Sankyo Pharma Inc.; Food and Drug Administration; Forest Laboratories, Inc. ST: New Jersey, Japan IN: BIO HEA MTC SU: PDT EXE
Sankyo Pharma Submits Supplemental New Drug Application for New
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