PARSIPPANY, N.J. and NEW YORK, Oct. 12 Daiichi Sankyo, Inc.and Forest Laboratories, Inc. (NYSE: FRX) announced today that they havesigned a contract for a co-promotion agreement in the United States forDaiichi Sankyo's AZOR(TM), a fixed combination of two antihypertensives, thecalcium channel blocker, amlodipine and the angiotensin receptor blocker,olmesartan medoxomil. The companies announced a signed letter of intent forthe co-promotion agreement on August 21, 2007.
Daiichi Sankyo received U.S. Food and Drug Administration marketingapproval for AZOR on September 26, 2007. As previously announced, Forest willmake an upfront payment of $20 million to Daiichi Sankyo, which will be madein the current quarter.
AZOR is indicated for the treatment of hypertension, alone or with otherantihypertensive agents. AZOR is not indicated for initial therapy ofhypertension. AZOR is a convenient, once daily, single tablet combination ofamlodipine, the number one prescribed calcium channel blocker (CCB) on themarket, and olmesartan medoxomil. The combination of these two medicationswill give doctors a powerful new treatment option for patients withhypertension who need to reduce their blood pressure levels or who areuncontrolled on other medications.
In clinical trials, AZOR produced significant mean reductions in seatedsystolic and diastolic blood pressure in patients with hypertension. Accordingto the pivotal registrational trial, AZOR 10/40 mg reduced systolic bloodpressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0mm Hg. These results were in comparison with mean reductions of 19.7 mm Hgsystolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo = 4.8/3.1 mmHg). When compared to amlodipine 10 mg alone, AZOR 10/40 mg resulted in a 53percent greater reduction in the mean change of systolic blood pressure.
IMPORTANT SAFETY INFORMATION ABOUT AZOR
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs thatact directly on the renin-angiotensin system can cause injury and even deathto the developing fetus. When pregnancy is detected, AZOR should bediscontinued as soon as possible. See WARNINGS AND PRECAUTIONS, Fetal/NeonatalMorbidity and Mortality.
In volume- and/or salt-depleted patients, symptomatic hypotension dueparticularly to the olmesartan component may occur after initiation oftreatment with AZOR. Treatment should start under close medical supervision.
Patients, particularly those with severe obstructive coronary arterydisease, may develop increased frequency, duration, or severity of angina oracute myocardial infarction on starting calcium channel blocker therapy.
In studies of ACE inhibitors in patients with unilateral or bilateralrenal artery stenosis, increases in serum creatinine or blood urea nitrogen(BUN) have been reported. There has been no long-term use of olmesartanmedoxomil in patients with unilateral or bilateral renal artery stenosis, butsimilar effects would be expected with AZOR because of the olmesartanmedoxomil component.
Since amlodipine is extensively metabolized by the liver and the plasmaelimination half-life (t1/2) is 56 hours in patients with severely impairedhepatic function, caution should be exercised when administering AZOR topatients with severe hepatic impairment. The only adverse event that occurredin greater than or equal to 3% of patients treated with AZOR and morefrequently than placebo was edema. The placebo-subtracted incidence was 5.7%(5/20mg), 6.2% (5/40mg), 13.3% (10/20mg), and 11.2% (10/40mg). The edemaincidence for placebo was 12.3%.
Please see full prescribing information for AZOR.
About Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S.subsidiary of Daiichi Sankyo Co., Ltd., Japan's second lar