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New meta-analysis on pitavastatin demonstrates no adverse effect compared with placebo or other statins on new-onset diabetes in non-diabetic patients at risk for cardiovascular disease

First-ever meta-analysis of pitavastatin confirms no significant adverse effect compared with placebo or other statins on fasting blood glucose, HbA1c, or new-onset diabetes

FOR IMMEDIATE RELEASE

MONTGOMERY, AL, May 4, 2015 – Kowa Pharmaceuticals America, Inc., announced that the results of a meta-analysis of 15 randomized, controlled clinical trials, to assess the effects of LIVALO® (pitavastatin) on glycemic parameters and new-onset diabetes (NOD) in non-diabetic individuals were presented as a late-breaking abstract at the 83rd European Atherosclerosis Society (EAS) Congress held in Glasgow, UK. The analysis was performed by Professor Kausik Ray, now of Imperial College London, and a team at St George’s, University of London, UK. This first-ever meta-analysis of pitavastatin data showed that pitavastatin had no significant adverse effect on parameters of glucose metabolism [fasting blood glucose (FBG) or HbA1c] or NOD.

A total of 15 randomized controlled studies (including four unpublished studies), involving 4,815 non-diabetic patients, were included in the meta-analysis. The weighted mean follow-up overall (n=15 studies) was 17.3 ± 17.7 weeks (approx. 1,600 person-years). Most studies had a follow-up time of 12 weeks (n=11 studies). For those with a longer follow-up (n=4 studies), this time ranged from 32 to 120 weeks with a weighted mean follow-up of 59.5 ± 28.5 weeks. Overall results confirmed, no significant differences associated with pitavastatin versus placebo/other statins were observed for FBG [mean difference (95% CI): -0.01(-0.77-0.74); for HbA1c: -0.03 (-0.11-0.05)] or for NOD [risk ratio: 0.70 (0.30-1.61); risk difference: -0.00 (-0.00-0.00)].

“This new meta-analysis confirms the results of our previously presented retrospective and prospective, prespecified data on glucose parameters for pitavastatin from our phase 3 and phase 4 clinical studies,” said Dr. Craig Sponseller, Vice President of Medical Affairs at Kowa Pharmaceuticals America, Inc. “Importantly, this analysis included doses ranging from 1 mg to as high as 8 mg, and the results suggest there is no dose-dependent relationship.”

“Current guidelines emphasize appropriate statin selection for patients with hypercholesterolemia,” said Ben Stakely, CEO and President, Kowa Pharmaceuticals America, Inc. “It is important for healthcare providers and patients to discuss therapeutic options and relevant clinical data like this to best approach individual treatment and patient-centric care, particularly for those at risk for cardiovascular disease.”

About LIVALO

LIVALO is a HMG-CoA reductase inhibitor (statin) indicated 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 high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use:

LIVALO was launched in the U.S. in June 2010.

Primary Hyperlipidemia and Mixed Dyslipidemia

Primary hyperlipidemia is defined as an elevation of cholesterol, particularly "bad" cholesterol (LDL-C), triglycerides (TG), or both. Mixed dyslipidemia is usually characterized by an elevation of LDL-C, TG, and a decrease in the "good" cholesterol (HDL-C) in the blood.

Important Safety Information for LIVALO® (pitavastatin) tablets

Who should NOT take LIVALO?

LIVALO is not right for everyone. Do not take LIVALO if:

What is the most important information I should know and talk to my doctor about?

What are the most common side effects of LIVALO?

The most common side effects of LIVALO in clinical studies were:

This is not a complete list of side effects. Talk to your healthcare provider for more information. You are encouraged to report negative side effects of all drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store and take LIVALO?

Other important information I should know about LIVALO.

For additional information please see the full Prescribing Information.
©Kowa Pharmaceuticals America Inc. (2013) LIV-RA-0086 10/2013

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

Kowa Company, Ltd. (Kowa) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceuticals, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on research and development for cardiovascular therapeutics (dyslipidemia, type 2 diabetes and atherosclerosis), ophthalmology and anti-inflammatory agents. The company’s flagship product, LIVALO® (pitavastatin), is approved in 45 countries around the world.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of cardiometabolic diseases. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.

LIVALO is a registered trademark of the Kowa group of companies.

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