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Kowa Pharmaceuticals America, Inc. Announces Court Decision to Uphold Patent Protection for LIVALO® (pitavastatin calcium)

FOR IMMEDIATE RELEASE

MONTGOMERY, AL, October 11, 2017 (BUSINESS WIRE) – Kowa Pharmaceuticals America, Inc. announced today that the U.S. District Court, Southern District of New York, has found that the U.S. Patent 8,557,993 (the “’993 patent") protecting LIVALO® (pitavastatin calcium) is valid, and that generic drug manufacturer Apotex, Inc. and Apotex Corp. ("Apotex")’s proposed Abbreviated New Drug Application (ANDA) product would infringe the ‘993 patent.

Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd. (collectively, "Plaintiffs"), manufacturers of the cholesterol-lowering drug LIVALO, brought suit against Defendants Amneal Pharmaceuticals LLC, and Apotex, Inc. and Apotex Corp., for alleged patent infringement based on the filing of the Defendants’ ANDAs seeking Food and Drug Administration (FDA) approval to market 1 mg, 2 mg, and 4 mg pitavastatin calcium tablets, generic to LIVALO. In response to these suits, the Defendants had contended that the '993 patent is invalid as (1) anticipated based on prior art, under 35 U.S.C. § 102(b); and/or (2) obvious in view of prior art, under 35 U.S.C. § 103. Only Apotex asserted non-infringement; Amneal conceded infringement.

The Court concluded that the Plaintiffs proved that Apotex's proposed ANDA product literally infringes, or contributes to the infringement of, certain claims of the '993 patent. The Court further concluded that Amneal and Apotex failed to prove invalidity of the ‘993 Patent. The Plaintiffs are directed to submit a proposed judgment by October 6, 2017.

In addition to the Court’s decision on the ‘993 patent, the Court also recently upheld the validity of another patent which covers LIVALO, U.S. Patent 5,856,336, in a separate decision in April, 2017, relating to the same trial. Both Amneal and Apotex conceded infringement of the ‘336 Patent, and Apotex conceded its validity. The Court concluded that Amneal failed to prove invalidity of the ‘336 patent. The U.S. Patent Trial and Appeal Board had also previously rejected three separate petitions by other companies for inter partes review, challenging the ‘336 Patent.

Several additional lawsuits were brought against other generic companies, all of which settled.

"We are very pleased with the Court's rulings upholding the infringement and validity of the patents for LIVALO," said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc. "We look forward to continuing to supply this life-saving product to patients, and will continue to actively protect and defend our intellectual property."

Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc., and Nissan Chemical Industries, Ltd. were represented by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.


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 provided, or visit 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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