NFL Legend Kurt Warner Announces First and Goal "Big Game Sweepstakes"

NEW YORK, May 29, 2014 /PRNewswire/ -- National heart-health initiative, First and Goal, today announced the launch of a consumer sweepstakes encouraging those living with high cholesterol and their support systems to join the First and Goal Team and pledge to prioritize heart health. The Campaign is a partnership with Kurt Warner, Super Bowl champion and two-time NFL MVP, his wife Brenda and Kowa Pharmaceuticals America, Inc.

Now through November 30, 2014, by completing the Four Downs of Cholesterol Management or sharing a heart-healthy tailgating recipe, you can enter for a chance to win a trip for two to the 2015 Big Game, with round trip transportation to Glendale, Arizona and hotel accommodations. Plus, 100 First Prize winners will receive one of the following: either an autographed Kurt Warner football, a $100 gift card to host a heart-healthy tailgating party or a gift bag with First and Goal items. All winners will be selected in a random drawing and announced in early 2015. Entries can be submitted on the Campaign website, FirstandGoalHeartHealth.com.

"For me, cholesterol management is about taking small steps to get to the big win," shared Kurt Warner. "We are excited to launch this new sweepstakes that gives people more information and resources to put their heart health first, and the chance to celebrate their wins by going to the biggest game in pro football."

As one of the most recognized names in football, Kurt holds numerous league records and is ranked among the top quarterbacks to ever play the game. Nearly a decade ago, while still in the pros, Kurt was diagnosed with high cholesterol. After his retirement from football, he tried several medications and, in conversations with his doctor about his lifestyle and concerns with treatment-related side effects, he developed a personalized game plan to manage his high cholesterol. Kurt's game plan includes the once-daily statin, LIVALO^® (pitavastatin), and a diet and exercise regimen with support from his doctor and wife, Brenda.

First and Goal seeks to re-engage people in their treatment by offering downloadable resources that focus on small steps that lead to reaching their personalized heart health goals.  At the start of the football season, the Campaign will launch an education effort around heart-healthy recipes, providing sports fans the opportunity to enjoy tailgating food while still sticking to their cholesterol game plan. Selected recipes will be turned into a digital cookbook available to those who join the First and Goal Team. 

"Getting high cholesterol under control can be a daunting prospect, as many patients have trouble sticking with their treatment game plan," said Dr. Eliot Brinton, President of the Utah Lipid Center. "First and Goal enables patients to work closely with their physicians and families to take charge of their heart health and create a plan that works well for them, and, most importantly, inspires them to stay engaged with the goal of long-term success."

For more information and to access the sweepstakes official rules for entry, visit FirstandGoalHeartHealth.com/Sweepstakes.

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 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 40 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.

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.

Lisa Garman
Kowa Pharmaceuticals America, Inc.
Mobile (334) 296-1917
[email protected]

Eliza Merves
Makovsky for Kowa Pharmaceuticals America, Inc.
Office (212) 508-9631
Mobile (908) 256-1243
[email protected]

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SOURCE Kowa Pharmaceuticals America, Inc.