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Data Showed After 52 Weeks, LIVALO® (pitavastatin) 4 mg Maintained Similar Safety and Significantly Greater LDL-C Reduction Compared with Pravastatin 40 mg in HIV-infected Adults with Dyslipidemia

May 1, 2014

Study results presented at the National Lipid Association Scientific Sessions 2014

ORLANDO, Fla., May 1, 2014 /PRNewswire/ — Kowa Pharmaceuticals America, Inc. announced results of a pre-specified safety analysis from the INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) trial evaluating the effect of LIVALO(®) (pitavastatin) 4 mg compared with pravastatin 40 mg in HIV-infected adults with dyslipidemia following completion of the 40-week safety extension. INTREPID was a Phase 4, multicenter, 12-week randomized superiority study demonstrating superior LDL-C reduction for LIVALO 4 mg vs. pravastatin 40 mg at Week 12 and included a 40-week safety extension (NCT01301066) with secondary objectives to compare the safety and lipid profiles at Week 52.

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Results of the extension showed that, after 52 weeks of therapy, safety profiles were maintained and consistent with 12-week results with an overall incidence of treatment emergent adverse events (TEAEs) of 67.5% for pitavastatin (N=126) and 69.8% for pravastatin (N=126). The most frequently reported TEAEs overall (occurring in >5% of subjects in either group) included upper respiratory infection (19 subjects, 7.5%); diarrhea (16 subjects, 6.3%); sinusitis (14 subjects, 5.6%); nasopharyngitis (13 subjects, 5.2%); bronchitis (11 subjects, 4.4%); nausea (11 subjects, 4.4%); and headache (10 subjects, 4.0%). Eleven subjects discontinued due to TEAE (4.4%) and there were no deaths. In addition, pitavastatin 4 mg maintained significantly greater reductions in LDL-C compared with pravastatin 40 mg at 52 weeks (pitavastatin -47.8 mg/dL and pravastatin -32.6 mg/dL, 30% vs. 20% reduction in LDL-C, respectively; LS mean % change -8.4, p<0.001). The results of the 40-week extension study and the pre-specified safety and efficacy analysis are being presented this week at the National Lipid Association’s Scientific Sessions in Orlando, FL.

According to the recent 2013 IDSA Update of Primary Care Guidelines for the management of persons infected with HIV, people with HIV are living longer, creating a larger need for physicians to focus on preventative care for high cholesterol and diabetes. Dyslipidemia is a common co-morbidity and HIV-infected adults are at an increased risk for cardiovascular disease due to many factors, including lipid abnormalities.

“We are pleased the results showed the adverse event profiles and overall safety was maintained and consistent with 12-week safety data,” said Dr. Craig Sponseller, Vice President of Medical Affairs at Kowa Pharmaceuticals America, Inc. “Moreover, pitavastatin 4 mg continued to demonstrate significantly greater LDL-C reduction compared with pravastatin 40 mg after 52 weeks of treatment in the HIV-infected adult population with high cholesterol.”

Study investigator, Dr. Judith Aberg, Director of Infectious Disease, Icahn School of Medicine at Mount Sinai, New York, NY, said, “The findings of the INTREPID study are an important advance in potential treatment options for HIV-infected adults with high cholesterol. These results will serve to further physician education on statin use for HIV-infected individuals.”

Additional INTREPID data presented separately from a post-hoc analysis evaluating age as a risk factor for CVD and change in lipid profiles, revealed that over 70% of subjects had age as a risk factor and that pitavastatin 4 mg demonstrated significantly greater reductions in atherogenic lipid parameters (LDL-C, apolipoprotein B, and non-HDL-C) compared with pravastatin 40 mg in men 45 years and older and women age 55 years and older.

About the Study

In the 12-week, Phase 4, randomized (1:1), double-blind, double-dummy superiority study, 252 patients were randomized to receive once-daily doses of pitavastatin 4 mg or pravastatin 40 mg, followed by a 40-week, double-blind safety extension study. Only patients who had fasting serum LDL-C levels between 130-220 mg/dL and triglycerides levels equal to or less than 400 mg/dL after the minimum 4-week dietary stabilization period were included in these analyses. Mean changes from baseline to week 52 were compared between treatments using ANCOVA, with percent change in lipid parameter as the dependent variable, and treatment as the independent variable, adjusting for site and hepatitis B or C at randomization.

About LIVALO

LIVALO is a HMG-CoA reductase inhibitor 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:

    --  Doses of LIVALO greater than 4 mg once daily were associated with an
        increased risk for severe myopathy in premarketing clinical studies. Do
        not exceed 4 mg once daily dosing of LIVALO.
    --  The effect of LIVALO on cardiovascular morbidity and mortality has not
        been determined.
    --  LIVALO has not been studied in Fredrickson Type I, III, and V
        dyslipidemias.

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 you have a known
        allergy to LIVALO or any of its ingredients.
    --  You have active liver problems, including some abnormal liver test
        results.
    --  You are nursing, pregnant or may become pregnant, as it may harm the
        baby.
    --  You are currently taking cyclosporine or gemfibrozil.

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

    --  Call your healthcare provider or get help right away if you experience
        any symptoms of an allergic reaction, such as rash, itching, or hives.
    --  Muscle problems may be an early sign of rare, serious conditions. Tell
        your doctor right away if you have any unexplained muscle pain,
        weakness, or tenderness, particularly if accompanied by malaise or
        fever, or if these muscle signs or symptoms persist after discontinuing
        LIVALO.
    --  Serious liver problems have been reported rarely in patients taking
        statins, including LIVALO. Your doctor should do liver tests before you
        start, and if you have symptoms of liver problems while you are taking
        LIVALO. Tell your healthcare provider right away if you feel more tired
        than usual, have a loss of appetite, upper belly pain, dark-colored
        urine, or yellowing of the skin or eyes.
    --  Tell your doctor about all your medical conditions and medications you
        take including nonprescription medicines, vitamins, or herbal
        supplements.
    --  Increases in blood sugar levels have been reported with statins,
        including LIVALO.
    --  Tell your doctor about your alcohol use.

What are the most common side effects of LIVALO?

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

    --  Back pain
    --  Muscle pain
    --  Constipation
    --  Pain in the legs or arms
    --  Diarrhea

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?

    --  Store LIVALO tablets at room temperature, in a dry place, and out of the
        reach of children.
    --  LIVALO can be taken at any time of day, with or without food.
    --  Swallow the tablet whole. Do not split, crush, dissolve, or chew.

Other important information I should know about LIVALO.

    --  LIVALO has not been studied to evaluate its effect on reducing
        heart-related disease or death.
    --  LIVALO is available by prescription only.

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 cardiovascular therapeutics, and the company’s flagship product, LIVALO(®) (pitavastatin) is approved in 40 countries around the world.

Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is a cardiology and primary care pharmaceutical company focused primarily in the area of cardiovascular disease. Established in September 2008, Kowa Pharmaceuticals America focuses its efforts on the acquisition, licensing and marketing of pharmaceutical products. For more information about Kowa Pharmaceuticals America, visit www.kowapharma.com.

This press release contains certain forward-looking statements about LIVALO(®), a HMG-CoA reductase inhibitor 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. This release reflects Kowa’s current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to-date or that LIVALO will be commercially successful.

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

Refer to: Lisa Garman

Kowa Pharmaceuticals America, Inc.

Mobile (334) 296-1917

lgarman@kowapharma.com

Eliza Merves

Makovsky for Kowa Pharmaceuticals America, Inc.

Office (212) 508-9631

Mobile (908) 256-1243

emerves@makovsky.com

Logo – http://photos.prnewswire.com/prnh/20140429/81841

SOURCE Kowa Pharmaceuticals America, Inc.


Source: PR Newswire



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