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.
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.
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
- 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
Important Safety Information for LIVALO (pitavastatin) tablets
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.
- LIVALO should be prescribed with caution in patients with predisposing factors for myopathy.
- The risk of skeletal muscle effects (e.g., myopathy and rhabdomyolysis) increases in a dose-dependent manner with advanced age (≥65 years), renal impairment, inadequately treated hypothyroidism, and in combination use with fibrates or lipid-modifying doses of niacin (≥1 g/day).
- LIVALO should be administered with caution in patients with impaired renal function, in elderly patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin.
- Concomitant administration of LIVALO with gemfibrozil should be avoided.
- LIVALO therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. LIVALO therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled seizures).
- Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and to discontinue LIVALO if these signs or symptoms appear.
- Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing LIVALO with colchicine.
- There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. IMNM has not been reported with LIVALO therapy.
- Advise patients to promptly report if muscle signs and symptoms persist after discontinuing LIVALO as this may be a sign of IMNM requiring immediate medical attention.
Liver Enzyme Abnormalities
Increases in serum transaminases have been reported with HMG-CoA reductase inhibitors, including LIVALO.
- It is recommended that liver enzyme tests be performed before the initiation of LIVALO and if signs or symptoms of liver injury occur.
- There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pitavastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with LIVALO, promptly interrupt therapy. If an alternate etiology is not found do not restart LIVALO.
- Advise patients to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
- LIVALO should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease.
Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIVALO.
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.