8/1/2017
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`Pharmaceuticals and Medical Devices | Business | Kaken Pharmaceutical Co.,Ltd.
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`I Pharmaceuticals and Medical Devices
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`Artz (Anti-osteoa rthritis Product)
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`Artz is an anti-osteoarthritis drug. Its active pharmaceutical ingredient is purified sodium hyaluronate extracted from rooster combs, and it has
`viscoelastic, water-retentive, and lubricating properties. In 1987, Artz was introduced into the market as the world’s first sodium hyaluronate dru
`indicated to treat osteoarthritis of the knee by intra—articular injection. In 1989, an indication was added for the treatment of shoulder periarthrit
`In 1992, Artz began being marketed in disposable pre-filled syringes under the trade name Artz Dispo. Artz Dispo was done with the aim of makin
`injection procedures simpler and faster as well as reducing the danger of infection. In 2005, Artz was approved for an indication to treat knee join
`pain accompanied by rheumatoid arthritis.
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`Clenafin (Topical Onychomycosis Treatment Product)
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`Launched in Japan in September 2014, Clenafin is the country’s first topical treatment for onychomycosis. Clenafin contains efinaconazole, whic
`was discovered by KAKEN, as its active ingredient. Clenafin does not bind well with keratin, the main component of nails, meaning that this drug
`superior nail penetrating properties. Clenafin has proven effective in treating onychomycosis through one daily application to the infected nails.
`Clenafin comes packaged in a bottle with a connected brush, making it easy to apply the drug across the surface of nails. In 2014, Clenafin was
`launched in the United States and Canada under the trade name Jublia by Canadian company Valeant Pharmaceuticals International, Inc.
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`Seprafilm (Anti-adhesive Absorbent Barrier)
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`Developed by Genzyme Corporation ofthe United States (which was later acquired by Sanofi S.A. of France), Seprafilm is a sheet-type anti-adhes
`absorbent barrier. Made from sodium hyaluronate and carboxymethyl cellulose, Seprafilm transforms into a hydrated gel within 24 to 48 hours a
`being applied to tissue that has been damaged by surgery. It then remains in place for approximately seven days, preventing adhesion by formin
`physical barrier between damaged tissue and the healthy tissue surrounding it. There are currently four sizes of Seprafilm available, thus allowin
`practitioners to select the size that best meets the needs at hand.
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`Lipidil (Anti-hyperlipidemia Product)
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`Lipidil is a fibrate-type anti-hyperlipidemic drug with fenofibrate, which was developed by Groupe Fournier SA of France (which was later
`transferred to Abbott Laboratories ofthe United States after acquisition by Solvay SA of Belgium), as its active pharmaceutical ingredient. This dr
`lowers triglycerides and total cholesterol, while increasing HDL (“good”) cholesterol, thus improving overall lipid metabolism. This is accomplish
`by activating peroxisome proliferator activated receptor a (PPARa) in the liver cells to adjust the expression of various lipid metabolism-related
`proteins. Lipidil is currently marketed in over 90 countries, and a significant amount of clinical experience has been accumulated to date. In 2011
`Lipidil was released in tablet form. The change from capsule to tablet has made Lipidil even easier for patients to take.
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`Fiblast Spray (Wound-healing Product)
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`Fiblast Spray is a wound-healing drug containing trafermin as an active pharmaceutical ingredient. Trafermin is a recombinant human basic
`Fibroblast Growth Factor (bFGF) that has effects on the promotion ofangiogenesis and granulation formation. The entire DNA sequence ofthe
`human bFGF gene was mapped by Scios Inc. (which was later acquired by Johnson & Johnson of United States), thus making it possible to
`manufacture recombinant human bFGF. KAKEN obtained a license to develop this product, and subsequently launched Fiblast Spray, the world’s
`first recombinant human bFGF product, in Japan in 2001.
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`Kaken Exhibit 2090
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`Acrux V. Kaken
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`IPR2017-0019O
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`8/1/2017
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`Pharmaceuticals and Medical Devices | Business | Kaken Pharmaceutical Co.,le.
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`Mentax (Anti-trichophyton Product)
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`Mentax is a topical product used to treat superficial mycosis. Mentax contains butenafine hydrochloride, 3 compound developed by KAKEN, as ai
`active pharmaceutical ingredient. Mentax is provided in three forms, as a cream, a liquid (for external application), and a spray. Mentax is sold in
`United States by Mylan Pharmaceuticals and is also marketed in a number of other countries worldwide. In December 2001, Mentax received
`approval as an over-the-counter (OTC) drug in the United States, and it is now sold in the United States by BayerAG of Germany (which acquired 1
`consumer care business of Merck Consumer Care, the company originally licensed to sell Mentax in this market) under the trade name Lotrimin
`Ultra.
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`Generic Drugs
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`In Japan, the public is being encouraged by the government to use generic drugs as part ofa movement to reduce public healthcare costs. As a
`result, there has also been an increasing trend toward using generic drugs in the medical field. KAKEN sees the future expansion of the generic dI
`market as a significant business opportunity, and is therefore aggressively increasing its presence in this market in order to take full advantage 0
`this opportunity.
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