NFL MVP Kurt Warner And Wife Brenda Tackle A Public Health Issue Affecting Millions Of Americans With National Cholesterol Awareness Campaign

NEW YORK, April 2, 2014 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. today announced a partnership with Kurt Warner, Super Bowl winner and two-time NFL MVP, and his wife Brenda, to launch First and Goal, a national education initiative to help people prioritize heart health. The campaign encourages the 71 million Americans living with high cholesterol to develop a personalized game plan to get to "goal." 

"I first started treating my high cholesterol when I was still in the NFL. I found the key to success is making small steps toward achieving your goal; whether managing your cholesterol, making the cut in professional football, or taking home a championship ring," shared Kurt Warner. "I'm excited to launch First and Goal with Kowa and my wife, Brenda, my biggest coach and cheerleader when it comes to family health. We hope to inspire others struggling with treatment to get back in the game."

Kurt was diagnosed with high cholesterol nearly a decade ago. With a growing family and a pro career to stay healthy for, Kurt knew he needed to be 100% committed to his treatment plan. And not just for a few months; for the rest of his life. 

Now, as a father of seven and an on-the-go lifestyle, staying heart healthy is more important than ever. In partnership with his doctor and Brenda, Kurt is managing his cholesterol with LIVALO^® (pitavastatin), a once-daily statin, in conjunction with a diet and exercise regimen.

First and Goal helps initiate productive conversations around cholesterol treatment, a significant public health issue. Up to 75% of Americans stop taking statins, the most commonly prescribed therapy, within the first year, demonstrating the clear need for more education and supportive resources.  The campaign also includes prompts to speak with their doctor about the potential for drug-drug interactions, a common reason why patients stop taking statins.

"Additionally, studies show many people with high cholesterol are not successful in their first treatment attempt, be it diet and exercise or taking medication as prescribed by their doctor. This leaves a large number of patients feeling discouraged about achieving long-term control of their cholesterol levels," said Dr. Eliot Brinton, President of the Utah Lipid Center. "The First and Goal initiative is an important effort to promote cardiovascular education among patients with high cholesterol. It is designed to renew and re-focus the treatment dialogue between patients and their doctors."

The online hub, FirstandGoalHeartHealth.com, is designed for both people with high cholesterol and their support systems at home, and includes:

• Kurt's personal treatment experience and lessons learned over a decade of cholesterol management
• Brenda's healthy lifestyle tips, including advice on meal planning and making lasting changes to get the entire family more active
• Four Downs of Cholesterol Management tracker to log each user's personalized treatment plan and track progress in collaboration with a healthcare professional
• My Medication Tracker to share important information across your team of healthcare providers and identify any drug interaction concerns—a significant discussion point, as eight out of ten patients use at least one medication or supplement with a known statin interaction potential

People are encouraged to visit FirstandGoalHeartHealth.com for updates on campaign activities and to store their cholesterol game plan.

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.

In addition to being launched in the U.S. in June 2010, LIVALO has been approved in 33 other countries around the world as of May 2013.

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. (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 $567 million in Japan in 2012, and was launched in the United States in June 2010.

Kowa Pharmaceuticals America, Inc. (KPA) is a pharmaceutical company specializing primarily in the area of cardiometabolic diseases. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by KCL in September of 2008. A privately held company, KPA directs its efforts towards the acquisition, licensing and marketing of pharmaceutical products.

exchange rate used $1=90JPY

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.

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SOURCE Kowa Pharmaceuticals America, Inc.