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FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia
Date:8/3/2009

MONTGOMERY, Ala. and MORRISVILLE, N.C., Aug. 3 /PRNewswire/ -- Kowa Research Institute (KRI) based in Morrisville, NC and Kowa Pharmaceuticals America, Inc. (KPA), a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. Food and Drug Administration (FDA) has approved LIVALO(R) (pitavastatin), a potent HMG-CoA reductase inhibitor (statin), for the primary treatment of hypercholesterolemia and combined dyslipidemia.

"The approval of LIVALO is a testament to the commitment and skill of Kowa's clinical development and regulatory groups in successfully bringing a new therapeutic option to a large, competitive market for cardiometabolic disorders," said Ben Stakely, CEO and President, KPA. "KPA is very pleased with the approval of LIVALO and is excited about the opportunity to introduce this new therapeutic option to physicians and patients."

"LIVALO has a robust safety, efficacy and tolerability profile and offers an attractive alternative for patients with primary hypercholesterolemia or combined dyslipidemia," said Antonio M. Gotto Jr., M.D., D.Phil, the Stephen and Suzanne Weiss Dean of Weill Medical College of Cornell University, New York. "LIVALO has very positive attributes that will help continue to fill current unmet needs in the statin market for clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions."

About LIVALO

LIVALO is a fully synthetic and highly potent statin engineered in Japan. LIVALO differs from other, currently available statins in the U.S. 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 low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. Importantly, pitavastatin is only minimally metabolized by the liver through the cytochrome P450 pathway, through which many other medications are metabolized.

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.

LIVALO is expected to launch in the U.S. during Q1 of 2010 and will be available in 3 low dosages (1 mg, 2 mg and 4 mg). After a thorough review of the statin market, KPA is also seeking a co-promotion partner in order to broaden the reach of KPA's rapidly growing internal sales force. Partnering with another organization to expand the sales efforts for this product is aligned with KPA's long-term vision to become a leader in the cardiometabolic therapeutic arena.

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.

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 total cholesterol, LDL-C, and triglyceride (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 U.S., 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 cholesterol level of 130mg/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( )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(R) (pitavastatin), 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 therapeutic area. 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 triglycerides 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 U.S. for KCL. KRI was established in California in 1997 and began operations at its current location in 2003.

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


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SOURCE Kowa Pharmaceuticals America, Inc.
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