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AZOR(TM) Receives FDA Approval for Treatment of High Blood Pressure
Date:9/27/2007

Powerful New Combination Treatment Option Reduces Mean Systolic Blood

Pressure Up to 30 Points

PARSIPPANY, N.J., Sept. 27, 2007 /PRNewswire/ -- Daiichi Sankyo, Inc. announced today that the United States Food and Drug Administration (FDA) has approved AZOR(TM) (amlodipine and olmesartan medoxomil) for the treatment of hypertension, also known as high blood pressure. AZOR is a convenient, once daily, single tablet combination of amlodipine, the number one prescribed calcium channel blocker (CCB) on the market(1), and olmesartan medoxomil, the active ingredient in Benicar(R), which is the fastest growing angiotensin receptor blocker (ARB).(2) The combination of these two medications will give doctors a powerful new treatment option for patients with hypertension who need to reduce their blood pressure levels or who are uncontrolled on other medications.

In clinical trials, AZOR produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension. According to the pivotal registrational trial, AZOR 10/40 mg reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison with mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, AZOR 10/40 mg resulted in a 53 percent greater reduction in the mean change of systolic blood pressure.

"AZOR is a valuable treatment addition, since so many people in the United States with hypertension do not have their blood pressure adequately controlled,"(3) said Michael A. Weber, MD, Professor of Medicine, State University of New York, Downstate College of Medicine. "AZOR with its established efficacy and favorable side effect profile provides two complementary mechanisms of action to lower blood pressure. It will give physicians a new treatment option for patients wh
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SOURCE Daiichi Sankyo, Inc.
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