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Kowa Pharmaceuticals America, Inc. Enters into Co-Promotion Agreement with Allergan for BYSTOLIC® (nebivolol) in the United States

Kowa’s sales force will promote its cholesterol-lowering drug LIVALO® (pitavastatin) in tandem with Allergan’s blood pressure-lowering medication

FOR IMMEDIATE RELEASE

MONTGOMERY, AL, January 29, 2019 — Kowa Pharmaceuticals America, Inc. announced today that it has entered into an agreement with Allergan plc. to co-promote Allergan’s BYSTOLIC® (nebivolol), a beta blocker approved for the treatment of hypertension to lower blood pressure, in the United States. Kowa’s nationwide sales force will co-promote BYSTOLIC to cardiologists and select primary care healthcare providers across the country along with the company’s cholesterol-lowering drug LIVALO® (pitavastatin) tablets.

“Kowa has a long history of successfully co-promoting products within the cardiometabolic space, and this new partnership with Allergan aligns closely with our focus and expertise in the area of cardiometabolic diseases,” said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. “We remain committed to patients and healthcare professionals, and to providing therapies that help address serious and chronic conditions including high cholesterol and high blood pressure. Adding BYSTOLIC to our product portfolio expands our offering and will enhance our ability to support patients suffering from these diseases, which represent a significant public health issue.”

Under the terms of the co-promotion agreement, Kowa will deploy its approximately 300 cardiometabolic sales specialists to promote BYSTOLIC to cardiologists and select primary care healthcare providers, starting in February. Allergan will continue to promote BYSTOLIC to primary care healthcare providers.

The financial terms of this non-exclusive co-promotion agreement were not disclosed.

About High Cholesterol

High cholesterol is defined as total cholesterol ≥240 mg/dL based on guidelines from the National Institutes of Health (NIH). When cholesterol levels rise, thick, hard buildup can occur in the artery wall, narrowing arteries and slowing down or even blocking blood flow to the heart and brain. High cholesterol is a major risk for stroke and heart disease, the leading causes of death in the United States. It can be lowered through a healthy diet, exercise, and by taking a medication (like a statin) as recommended by a physician.

About Hypertension

According to the U.S. Centers for Disease Control and Prevention, hypertension has been called the "silent killer" because it often has no warning signs or symptoms and has been associated with serious cardiovascular (CV) risks, such as stroke and myocardial infarction. Hypertension represents a significant public health issue with high prevalence in the United States. According to the National Institute for Health Statistics, approximately 30 percent of adults in the U.S. have hypertension. Inadequate control of hypertension is a significant public health problem, with approximately half of all patients still not achieving target goals. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction that is largely responsible for those benefits. In addition, approximately two-thirds of hypertensive patients will require more than one drug to achieve blood pressure goals.


About LIVALO

LIVALO is an HMG-CoA reductase inhibitor (statin).

INDICATIONS AND USAGE

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

PRIMARY HYPERLIPIDEMIA AND MIXED DYSLIPIDEMIA

LIVALO (pitavastatin) is 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

Important Safety Information for LIVALO (pitavastatin) tablets

CONTRAINDICATIONS

LIVALO is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.

WARNINGS AND PRECAUTIONS

Skeletal Muscle Effects

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including LIVALO. These risks can occur at any dose level, but increase in a dose-dependent manner.

Liver Enzyme Abnormalities

Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including LIVALO.

Endocrine Function

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIVALO.

ADVERSE REACTIONS

In short-term controlled studies, the most frequent adverse reactions reported by ≥2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate ≥ placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). This is not a complete listing of all reported adverse events.

For additional information, please see the full Prescribing Information at www.LivaloRx.com.

© Kowa Pharmaceuticals America, Inc. (2016) - LIV-RA-0101 PI V-11-2016

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 business fields including the trading of textiles, machinery, and construction materials, in addition to the manufacturing and sales of medicines, medical equipment, and energy saving 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 46 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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