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BENICAR HCT(TM) (olmesartan medoxomil-hydrochlorothiazide) Now Available For the Treatment of Hypertension

Clinical Studies Demonstrate Combination's Significant Blood Pressure Lowering

Wednesday, September 10, 2003 8:08 am EDT



Public Company Information:


Sankyo Pharma Inc. and Forest Laboratories, Inc. (NYSE: FRX) announced today that BENICAR HCT(TM) (olmesartan medoxomil-hydrochlorothiazide) is now available via prescription in the United States. BENICAR HCT combines the angiotensin II receptor blocker (ARB) BENICAR(R) (olmesartan medoxomil) with the diuretic hydrochlorothiazide (HCTZ) for the treatment of hypertension. Clinical studies have demonstrated significant blood pressure lowering with BENICAR HCT.

"Studies prove that the combination of BENICAR plus hydrochlorothiazide yields very significant blood pressure drops in hypertensive patients," said Steven Chrysant, MD, PhD, lead investigator of the combination's pivotal trial and Professor of Medicine, University of Oklahoma and Director, Oklahoma Cardiovascular and Hypertension Center. "Hypertension is a multifactorial disease, with many patients requiring more than one agent for adequate blood pressure control. The new JNC 7 guidelines (1) recommend ARBs for a wider range of patients than previous guidelines, and also emphasize the need for more aggressive blood pressure lowering. The data on BENICAR HCT demonstrate the effectiveness of combination therapy."

National guidelines state that most hypertension patients will require two or more anti-hypertensive medications to achieve goal blood pressure levels of less than 140/90 mm Hg* (systolic/diastolic).(1+) Combination therapy with BENICAR HCT has been shown to produce significant placebo-adjusted average reductions in systolic and diastolic blood pressure -- up to 24/14 mm Hg, respectively. (2)


BENICAR HCT is approved for use in the treatment of hypertension. It is a new option for patients who are currently taking other anti-hypertension medications but not reaching goal. BENICAR alone is indicated for initial treatment using a starting dose of 20 mg with a demonstrated dose response for patients increased to 40 mg. Patients can be switched to BENICAR HCT if further blood pressure lowering is needed.

By combining BENICAR with hydrochlorothiazide, BENICAR HCT works by blocking angiotensin II receptors in the blood vessels and increasing excretion of sodium and chloride in approximately equivalent amounts, resulting in lower systolic and diastolic blood pressure. Angiotensin II increases blood pressure by causing the constriction of blood vessels, while sodium and chloride cause the retention of water, increase in blood volume and ultimately an increase in blood pressure.

Approved in June 2003 by the U.S. Food and Drug Administration (FDA), BENICAR HCT is available in three fixed-dose combinations: 20 mg olmesartan medoxomil/12.5 mg HCTZ; 40 mg olmesartan medoxomil/12.5 mg HCTZ; 40 mg olmesartan medoxomil/25 mg HCTZ, offering a range of dosing options for patients with hypertension. These complement the previously available monotherapy doses of BENICAR 20 mg and 40 mg.

BENICAR HCT(TM) (olmesartan medoxomil-hydrochlorothiazide)

Clinical Trial Data

The safety and efficacy of BENICAR HCT was evaluated in clinical trials of more than 1,200 patients. These trials included one placebo-controlled factorial trial, which evaluated 502 men and women with mild-to-moderate hypertension, who received combinations of BENICAR(R) (olmesartan medoxomil of 10 mg, 20 mg, or 40 mg) and HCTZ (12.5 mg, or 25 mg), or placebo. BENICAR HCT, given once a day, in doses of 20 mg olmesartan medoxomil/12.5 mg HCTZ; 40 mg olmesartan medoxomil/12.5 mg HCTZ; 40 mg olmesartan medoxomil/25 mg HCTZ produced placebo adjusted average blood pressure reductions ranging from 17/8 to 24/14 mm Hg. Onset of action occurred within one week of starting BENICAR HCT. (2)

Important Safety Information about BENICAR HCT

BENICAR HCT should not be used in women who are pregnant or by people who are allergic to any component of the medication. Because of the HCTZ component, this product 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.

BENICAR HCT has been evaluated for safety in more than 1,200 hypertensive patients. Treatment with BENICAR HCT was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of BENICAR HCT.

In a placebo-controlled clinical trial, the following adverse events reported with BENICAR HCT occurred in more than 2% of patients, and more often on the BENICAR HCT combination than on placebo, regardless of drug relationship: dizziness (9%), upper respiratory tract infection (7%), hyperuricemia (4%), and nausea (3%).

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 HCT should be discontinued as soon as possible. For full prescribing information, please refer to package insert.


BENICAR was approved by the FDA in April 2002. Studies have shown that BENICAR 20 mg taken once a day provides effective diastolic blood pressure reductions versus baseline and has shown a demonstrated dose response in patients when titrated to 40 mg. In two separate clinical trials, BENICAR established superior blood pressure-lowering efficacy over the ARB Cozaar(R) (losartan potassium). (3)

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 and BENICAR HCT are co-promoted by Sankyo Pharma and Forest Laboratories, Inc.

About Sankyo

Sankyo Pharma Inc. is dedicated to developing and marketing important pharmaceutical products for the U.S. market. A national sales force of 550 representatives promotes Sankyo Pharma products, and they are supported by dedicated managed care personnel.

Sankyo Pharma launched WelChol(R) (colesevelam HCI), a non-systemic lipid- lowering agent, in September 2000. Currently, WelChol is the number one prescribed agent in its category with 2002 sales in excess of $100 million dollars.

Sankyo Pharma also markets and distributes the GlucoWatch(R) G2(TM) Biographer, which is the first and only monitoring system to provide glucose readings automatically and non-invasively, and is used in conjunction with traditional blood glucose monitoring. The GlucoWatch G2 Biographer is developed and manufactured by Cygnus, Inc.

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, Inc. develops, manufactures, and sells pharmaceutical products that are used for the treatment of a wide range of illnesses. Forest Laboratories' growing line of products includes: Lexapro(TM), indicated for the initial and maintenance treatment of major depressive disorder; Celexa(TM), an antidepressant; Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment of asthma.

Except for historical information contained herein, this release contains forward-looking statements that involve 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, 2002 and subsequent quarterly reports on Form 10-Q. Actual results may differ from those projected.

* ?mm Hg = millimeters of mercury - units of blood pressure measurement

+ The Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure issued its seventh report (JNC 7) which specified that two or more antihypertensive agents may be required to achieve goal blood pressure in many patients with hypertension. The report also states that at least one of the agents should be a thiazide- type diuretic such as HCTZ.

Cozaar(R) is a registered trademark of Merck & Co.


(1) The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, April 4, 2003.
(2) BENICAR HCT Product Insert
(3) Data on file