New data demonstrates that Benicar(R) and Benicar HCT (TM) achieve JNC 7 blood pressure goals

05/26/04

Parsippany, NJ (May 26, 2004) – New data from two different clinical studies demonstrated that patients with hypertension can achieve more aggressive blood pressure goal rates using antihypertensive therapies BENICAR® (olmesartan medoxomil) or BENICAR HCTTM (olmesartan medoxomil/hydrochlorothiazide).

The first, recently published in the Journal of Clinical Hypertension, is a study that demonstrated that nearly seven out of ten or 69.3 percent of patients treated with BENICAR, or if needed with BENICAR HCT, were able to reach a more aggressive blood pressure goal of less than or equal to 130/85 mm Hg.

The second, presented at the annual meeting of the American Society of Hypertension, was a secondary analysis of data from a previously published clinical study. Data from this analysis showed that at the usual recommended starting doses, approximately twice as many patients treated with BENICAR achieved goal blood pressure of less than 140/90 mm Hg* compared to Cozaar® (losartan potassium) and Diovan® (valsartan), the two most commonly prescribed angiotensin II receptor blockers (ARBs).

In 2003, the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure issued its seventh report (JNC 7) outlining its more aggressive guidelines for hypertension prevention and management. These guidelines stress the importance of helping patients achieve goal blood pressure of less than 140/90 mm Hg, or less than 130/80 mm Hg for patients with diabetes or chronic kidney disease. These goals are important because the risk of cardiovascular disease (CVD) doubles with each increment of 20/10 mm Hg beginning at 115/75 mm Hg. JNC 7 guidelines also recommend a step-wise treatment approach, in which the dose of the first antihypertensive agent is titrated upwards and then additional agents added, as necessary, to achieve blood pressure goals.

"Most head-to-head trials of hypertension therapies compare the benefits of each agent in terms of how effective it is in decreasing millimeters of mercury, the measurement units of systolic and diastolic blood pressure," states Suzanne Oparil, MD, Professor of Medicine, and Director, Vascular Biology and Hypertension, University of Alabama at Birmingham. "However, in light of the JNC 7 guidelines, which stress the importance of achieving goal blood pressure rates, physicians also need to know how effective a therapy is in helping a patient reach goal." **

Hypertension, also known as high blood pressure, affects approximately 50 million people in the United States and approximately one billion worldwide. Called the "silent killer" because it often has no specific symptoms, hypertension increases the risk of cardiovascular and related diseases such as stroke, heart attack, heart failure and kidney disease.4

BENICAR and BENICAR HCT in Treating to Goal
An open-label, multicenter clinical study recently published in the Journal of Clinical Hypertension was designed to replicate the way physicians treat hypertension in clinical practice.1 The study assessed the effectiveness of a step-wise treatment regimen consisting of BENICAR and BENICAR HCT in getting patients to goal blood pressure of less than or equal to 130/85 mm Hg. Patients who met entry criteria began treatment with BENICAR (20 mg) once daily. If the blood pressure goal of less than or equal to 130/85 mm Hg was not met after four weeks of treatment, the antihypertensive therapy was titrated at each subsequent 4-week interval according to the following BENICAR-based treatment regimen: week 5 to 8 (BENICAR 40 mg once daily); week 9 to 12 (BENICAR 40 mg/12.5 mg HCTZ once daily); week 13 to 16 (BENICAR 40 mg/ 25 mg HCTZ once daily); week 17 to 20 (BENICAR 40 mg/25 mg HCTZ/5 mg amlodipine once daily); week 21 to 24 (BENICAR 40 mg/25 mg HCTZ/10 mg amlodipine once daily). Once the blood pressure goal of less than or equal to 130/85 was achieved, patients exited the study. Nearly seven out of ten (69.3 percent) patients reached the aggressive combined goal of less than or equal to 130/85 mm Hg using BENICAR or BENICAR HCT after 16 weeks of therapy.

The study also evaluated the effectiveness of the approach in reaching individual systolic and diastolic goals. At week eight, nearly two out of three (65.9 percent) patients reached goal diastolic blood pressure of less than or equal to 85 mm Hg on BENICAR monotherapy alone (20 and 40 mg). At week 16, nearly three out of four (72.6 percent) achieved goal systolic blood pressure of less than or equal to 130 mm Hg, and nearly nine out of ten (87.2 percent) achieved goal diastolic blood pressure of less than or equal to 85 mm Hg using BENICAR or BENICAR HCT.

BENICAR Compared to Other ARBs in Reaching Goal Blood Pressure
A secondary analysis of a previously published study2, presented at the annual meeting of the American Society of Hypertension, was an analysis of a head-to-head monotherapy study comparing the antihypertensive success of the usual starting doses of BENICAR (20 mg) once daily, Cozaar® (losartan potassium) (50 mg) once daily, Diovan® (valsartan) (80 mg) once daily and Avapro® (irbesartan) (150 mg) once daily. The objective of this analysis was to determine the percentage of patients who achieved the blood pressure goal of less than 140/90 mm Hg and less than 130/85 mm Hg with the starting doses of each drug. A total of 588 patients were randomized to eight weeks of double-blind treatment.3

The data demonstrated that twice as many patients who received BENICAR reached goal blood pressure of less than 140/90 mm Hg (32.4% of patients) compared to patients who received Cozaar (16.1% of patients) and Diovan (14.5% of patients), and approximately 25 percent more compared to patients who took Avapro (25.9% of patients). While less than 140/90 is the JNC 7 blood pressure goal for uncomplicated patients with hypertension, further analysis was completed at the more aggressive blood pressure goal of less than 130/85 and found that almost three times as many patients were able to reach this goal on BENICAR (12.5% of patients) compared to Cozaar (4.4% of patients) and Diovan (3.1% of patients), and about one-third more versus Avapro (9.4% of patients).

About BENICAR and BENICAR HCT
Angiotensin II is a hormone that interacts with a receptor on arterial blood vessels, which results in constriction and increasing blood pressure. In addition, angiotensin II stimulates the release of another hormone that causes enhanced sodium and chloride (salt) retention, with a resultant increase in vascular water retention and blood volume, that also contributes to an elevation in blood pressure. BENICAR lowers blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizes the release of the hormone which causes salt retention and increased blood volume. BENICAR HCT combines BENICAR with the diuretic hydrochlorothiazide. BENICAR and BENICAR HCT are approved for the treatment of hypertension. BENICAR and BENICAR HCT, like all drugs that act directly on the renin-angiotensin system such as members of the ARB class, should not be used in pregnant women. When pregnancy is detected, BENICAR and BENICAR HCT should be discontinued as soon as possible. BENICAR and BENICAR HCT should not be used by people who are allergic to any component of the medication. Because of the hydrochlorothiazide component, BENICAR HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. In volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur. Treatment should start under close medical supervision. Both products are co-promoted in the United States by Sankyo Pharma Inc. and Forest Laboratories, Inc.

About Sankyo Pharma
Sankyo Pharma Inc. is dedicated to developing and marketing important pharmaceutical products for the U.S. market. A national sales force of 530 representatives promotes Benicar and WelChol® (colesevelam HCI), and they are supported by dedicated managed care personnel. Sankyo Pharma promotes Benicar and Benicar HCT with its co-promote partner Forest Laboratories, Inc.

Sankyo Pharma launched WelChol, a non-systemic lipid-lowering agent, in September 2000. Currently, WelChol is the number one prescribed branded agent in its category with 2003 sales in excess of $100 million dollars. Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is one of Japan's largest pharmaceutical companies, with annual worldwide sales of $4.5 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 to be marketed. Additionally, Sankyo discovered, co-developed and manufactures pravastatin sodium.

About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro® an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and Generalized Anxiety Disorder; Celexa®, an antidepressant; Namenda®, an N-methyl D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Tiazac®, a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar®, an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCTTM, an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; and Aerobid®, an inhaled steroid indicated for the treatment of asthma.

Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2003, and Quarterly Reports on Form 10-Q for the periods ending June 30, 2003, September 30, 2003, and December 31, 2003. Actual results may differ materially from those projected.

Source: Eurekalert & others

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