Study Demonstrates LIVALO(R) Is an Efficacious Treatment for Achieving Lipid Goals LIVALO Superior to Simvastatin in Reducing LDL-C When Comparing Starting Doses

MONTGOMERY, Ala., Oct. 22 /PRNewswire/ -- New Phase III data published today in "Current Medical Research and Opinion" highlight that the recommended starting dose of 2 mg of LIVALO (pitavastatin), a novel synthetic statin, was statistically superior to simvastatin at a dose of 20 mg over 12 weeks in reducing low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC) in patients with primary hypercholesterolemia and combined dyslipidemia. With respect to LDL-C goal attainment, treatment with LIVALO was comparable to simvastatin according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines, but was superior based on European Atherosclerosis Society (EAS) guidelines.

Although statins are proven to reduce LDL-C levels, many patients treated with statins fail to reach or maintain recommended LDL-C goals. As many as six out of ten patients stop taking statins during the first twelve months, often due to poor compliance and/or side effects. Untreated and undertreated patients are at an increased risk for cardiovascular events, especially patients with a chronic condition such as diabetes.

"A need exists for an effective, well-tolerated statin that improves LDL-C and other lipid parameters while offering a low-dose regimen that may encourage patient compliance," said Leiv Ose, M.D., Ph.D., Rikshospitalet University Hospital, Norway. "The results of this study show that LIVALO is an efficacious, low-dose therapy that is comparable to the most commonly prescribed doses of simvastatin."

The prospective trial examined 857 subjects with primary hypercholesterolemia or combined dyslipidemia, comparing percent change in LDL-C in patients treated with LIVALO or simvastatin. Subjects were randomized to one of four treatment groups: LIVALO 2 mg, LIVALO 4 mg (2 mg for 4 weeks titrated to 4 mg for 8 weeks), simvastatin 20 mg and simvastatin 40 mg (20 mg for 4 weeks titrated to 40 mg for 8 weeks). The results showed that LIVALO 2 mg was statistically significantly superior to simvastatin 20 mg in lowering LDL-C, as well as non-HDL-C and TC. At the higher dose comparison across all lipid parameters, 4 mg of LIVALO was comparable to 40 mg of simvastatin.

Secondary endpoints included LDL-C target attainment, as defined by the NCEP ATP III and EAS guidelines. Although a greater percentage of patients treated with 2 mg or 4 mg of LIVALO achieved target LDL-C goals by NCEP criteria, results were comparable to simvastatin. However, by EAS criteria, low-dose LIVALO was statistically superior to low-dose simvastatin in percentage of patients achieving LDL-C goal. The safety and tolerability of both agents were comparable across low- and high-dose comparisons.

"This study demonstrated that when compared to an established first-line lipid-lowering agent, LIVALO is a clinically effective treatment choice for patients with primary hypercholesterolemia or combined dyslipidemia," said Dr. Neil Hounslow, vice president of scientific affairs, Kowa Research Europe. "LIVALO is poised to offer practical and clinical treatment advantages, which could encourage patient compliance and maintenance of treatment goals."

About LIVALO

LIVALO® was approved by the U.S. Food and Drug Administration in August 2009 as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

LIVALO is a fully synthetic and highly potent statin that differs from other, currently available statins in the United States in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater LDL-C clearance and reduction of plasma cholesterol. Importantly, LIVALO is only minimally metabolized by the liver through the cytochrome P450 pathway, a common pathway for the metabolism of many other medications.

In pivotal Phase III trials, LIVALO effectively reduced LDL-C and improved other parameters of lipid metabolism in special patient populations, including the elderly, patients with diabetes and patients at higher cardiovascular risk. The overall safety and tolerability of LIVALO are consistent with other commonly prescribed statins.

Since its launch in Japan, South Korea, Thailand and China, LIVALO has been successfully used in these countries to treat primary hypercholesterolemia and combined dyslipidemia, and has accumulated millions of patient-years of exposure. It is frequently prescribed in these countries as first-line therapy for a broad range of patients, including the elderly, patients with diabetes and those whose treatment is complicated by concurrent disease and concomitant medications. Kowa also filed for approval of LIVALO in Europe in August 2008, using the decentralized authorization procedure.

About Dyslipidemia and Hypercholesterolemia

Dyslipidemia refers to abnormal levels of fatty substances in the blood, or a disorder of the production or breakdown process of lipoprotein. Dyslipidemia may be marked by an elevation of TC, LDL-C, and TG concentrations and a decrease in HDL-C in the blood. An elevated level of cholesterol in the blood is called hypercholesterolemia, commonly referred to as high cholesterol.

Dyslipidemia is well established as one of the strongest independent predictors of cardiovascular morbidity and mortality. Despite the availability of treatments in the United States, there is still a need for better control of and treatment for dyslipidemia. According to the American Heart Association, approximately one out of every three American adults has an LDL-C level of 130 mg/dL or higher, which is a major risk factor for coronary heart disease (CHD) and stroke. In addition, less than half of patients who qualify for any kind of lipid-modifying treatment( )for CHD risk reduction are receiving it, and only about( )one-third of patients who are on treatment are achieving their LDL-C( )goals.

About Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Kowa Research Europe, Ltd.

Kowa Company, Ltd. (KCL) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in various manufacturing and commercial activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. KCL's pharmaceutical division is focused on cardiovascular therapeutics, with sales of the company's flagship product, LIVALO, totaling $340 million (12% market share) in Japan during the 2008 fiscal year and expected to exceed $600 million in the near future.

Kowa Pharmaceuticals America, Inc. (KPA) is a specialty pharmaceutical company focused primarily in the area of cardiometabolic therapeutics. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by KCL in September of 2008. A privately held company, KPA focuses its efforts on the acquisition, development, licensing and marketing of pharmaceutical products. Its lead product, LIPOFEN® (fenofibrate capsules), is indicated as adjunctive therapy to diet to reduce elevated TG and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

Kowa Research Europe, Ltd. (KRE), established in 1999 in the United Kingdom, is responsible for European clinical trials for Kowa's strategic global pharmaceutical development.

For more information about Kowa, please visit www.kowapharma.com.

SOURCE Kowa Company, Ltd.



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