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LIVALO(R) Demonstrates Sustained, Long-Term Efficacy and Tolerability in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Date:9/1/2009

BARCELONA, Spain, Sept. 1 /PRNewswire/ -- New data presented today showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks. Additionally, LIVALO was found to have comparable efficacy to atorvastatin and simvastatin, as measured by reduction in LDL-C from baseline. The Phase III data were presented at the European Society of Cardiology Congress (ESC) in Barcelona, Spain.

"These studies confirm that the efficacy of LIVALO is comparable to other commonly used statins, and that it is an effective and well tolerated long-term treatment option for patients," said Leiv Ose, M.D. Ph.D., Rikshospitalet University Hospital, Norway, and study investigator. "With many patients not reaching LDL-C targets with current statin therapies due to a number of factors, including noncompliance and the risk for drug-drug interactions, there is a need for a statin that has the potential to improve long-term treatment."

The primary objective of the two Phase III, double-blind, active-controlled studies was to demonstrate non-inferiority of LIVALO to atorvastatin and simvastatin, as measured by the reduction of LDL-C. Secondary objectives of the study were to assess National Cholesterol Education Program (NCEP) and European Atherosclerosis Society (EAS) LDL-C target attainment, other lipid and lipoprotein fractions, safety and tolerability. An open-label extension study was also conducted to assess the long-term safety and tolerability of LIVALO 4 mg once daily for up to 52 weeks.

"Data from these pivotal, Phase III studies show that LIVALO has a robust efficacy, safety and tolerability profile, and in terms of LDL-C reduction, stands up to atorvastatin and simvastatin at usual therapeutic doses," said Roger E. Morgan, M.D., Chief Medical Officer, Kowa Research Institute. "With sustained efficacy, low rates of discontinuation due to adverse events and steady, progressive increases in HDL-C observed over 52 weeks, LIVALO shows great promise for the long-term treatment of patients with hypercholesterolemia or mixed dyslipidemia."

Study 1

A total of 830 patients were randomized to one of four treatment groups: LIVALO (2 mg or 4 mg) or atorvastatin (10 mg or 20 mg), once daily. Results showed that LIVALO was comparable to atorvastatin in terms of reduction in LDL-C, and no significant differences emerged in the other endpoints. Adverse events with LIVALO and atorvastatin were also similar.

Study 2

A total of 857 patients were randomized to LIVALO (2 mg or 4 mg) or simvastatin (20 mg or 40 mg), once daily. Results showed that LIVALO 4 mg and simvastatin 40 mg were comparable in LDLC reduction, with low-dose LIVALO (2 mg) resulting in a greater reduction in LDL-C than simvastatin 20 mg. Additionally, low-dose LIVALO also showed significantly better decreases in total cholesterol and non-HDL-C than simvastatin 20 mg. Moreover, the percentage of patients who met the LDL-C goal, according to EAS guidelines, was also greater with low-dose LIVALO compared with simvastatin 20 mg. The tolerability profiles of LIVALO and simvastatin were similar.

Extension Study

The extension study demonstrated a favorable safety and tolerability profile for LIVALO 4 mg over the 52-week trial. Reductions in LDL-C were sustained over the 52-week period. In addition, a higher proportion of LIVALO-treated patients met the defined LDL-C target at the end of the extension study than at the end of the core study (74.0% NCEP and 73.5% EAS). Steady increases in HDL-C were observed throughout the extension period, reaching more than 14%.

About LIVALO

LIVALO(R) 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 Institute, Inc.

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 $500 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(R) (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 Institute, Inc. (KRI), a division of KCL located in the Research Triangle Park area of North Carolina, is responsible for the clinical development of drug candidates in the United States for KCL. KRI was established in California in 1997 and began operations at its current location in 2003.

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


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SOURCE Kowa Company Ltd., Kowa Pharmaceuticals America, Inc., and Kowa Research Institute, Inc.
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