R&D Pipeline | Research & Development Division | Business | Kaken P...
`
`http://www.kaken.co.jp/english/business/rd_pipeline.html
`
`HQM.E. I B1W1Jm I Resarch & Deye(qoment pjvisjon I MD Pipeline
`
`Business
`
`I Research & Development Division
`
`R&D Pipeline
`
`KAKEN's drug discovery research focuses on such areas of stn!ngtb as inflammation, immunity, alleraies and pain relief in addition to its core
`competence of fungal Infection disease. KAKEN Invest substantial financial and human resources Into such research activities with the aim of
`developing new drugs that are both efi'Ktlve and safe. To create new drugs that can compete In tile world market, we maintain an active program of
`drug discovery research, spearheaded by outstanding research professionals and techniques refined over many years of experience in
`pharmaceutical development.
`
`Code
`
`KAG-.308
`
`BBI-4000
`
`Indication
`
`Ulcerative colitis
`
`Primary focal hyperhidrosis
`
`KMw-1
`
`Removal of escbarwitll tllermal burns
`
`I KAKEN's Innovation Product for Regeneration
`
`Stage
`
`Pll
`
`Pll
`
`Preparing for clinical trial
`
`Flblast• (Recombinant human basic fibroblast powth faciDr, rh bFGF)
`
`Fiblast Spnsy is the world's first marketed product for regeneratiw medicine treatment containinJ recombinant
`human basic Fibroblast Growth Factor (bFGF). Present In almost all tissue In the human body, bFGF Is reteased from
`the extracellular matrix once tissue is dama&ee~, and then acts on various cells and tissues to stimulate tissue
`regeneration. While bFGF hasa wide variety of functions, its most prominent features are its powerful ability to
`stimulate cellular proliferation and Its capacity to promote neovasc:ularizatlon.
`
`In 1988, KAKEN obtained eJa:lusiw licensinJ riJhts for recombinant human bFGF (trafermin) in Asia flom Scios Inc., of
`the United States. Following this, KAKEH has pushed forward with Its own MD efforts, and subsequently obtained marketing approval for Flblast
`Spray for the treatment of pA!iSSure ulcers and otller skin ulcers (burn ulcers and leg ulcers) in June 2001. Further, after completing reexamination in
`2010, Fiblast Spnsy bas been re-acknowledged as a highly reliable drug. It is now used with confidence at a number of hospitals throughout Japan.
`
`Not only effective for n!generating skin tissue, trafermln has also demonstrated tile ability to promote tile proliferation and rvgeneratlon of both
`periodontal and bone tissues. In the field of dentistry, trafermin is known for its ability to promote the regeneration of periodontal ligaments,
`cementum, and alveolar bone. KAKEN has completed phase Ill clinical trial for this drug, and are currently In the process of preparing to file a new
`drug application for trafermin to be used in the tn!atment of periodontitis.
`
`In March 2005, KAKEN acquired the worldwide rights to develop, manufacture, and market for all therapeutic purposes. In June 2007, KAKEN
`entered a Ucenslng agreement with sunstar Inc. Nprdlng the development and marketing of trafermln for dental applications In Europe and North
`America. Further, in Nowmber 2009, KAKEN entered a licensing agreement with Olympus Corporation in relation to the development and marketing
`of trafermln for wound healing In Europe and North Ameflca. KAKEN also entered licensing agreements regarding tile development and marketing
`
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`10/30/17, 11:17 AM
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`Page 1 of 2
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`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1523
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`R&D Pipeline | Research & Development Division | Business | Kaken P...
`
`http://www.kaken.co.jp/english/business/rd_pipeline.html
`
`HQM.E. I B1W1Jm I Resarch & Deye(qoment pjvisjon I MD Pipeline
`
`Business
`
`I Research & Development Division
`
`R&D Pipeline
`
`KAKEN's drug discovery research focuses on such areas of stn!ngtb as inflammation, immunity, alleraies and pain relief in addition to its core
`competence of fungal Infection disease. KAKEN Invest substantial financial and human resources Into such research activities with the aim of
`developing new drugs that are both efi'Ktlve and safe. To create new drugs that can compete In tile world market, we maintain an active program of
`drug discovery research, spearheaded by outstanding research professionals and techniques refined over many years of experience in
`pharmaceutical development.
`
`Code
`
`KAG-.308
`
`BBI-4000
`
`Indication
`
`Ulcerative colitis
`
`Primary focal hyperhidrosis
`
`KMw-1
`
`Removal of escbarwitll tllermal burns
`
`I KAKEN's Innovation Product for Regeneration
`
`Stage
`
`Pll
`
`Pll
`
`Preparing for clinical trial
`
`Flblast• (Recombinant human basic fibroblast powth faciDr, rh bFGF)
`
`Fiblast Spnsy is the world's first marketed product for regeneratiw medicine treatment containinJ recombinant
`human basic Fibroblast Growth Factor (bFGF). Present In almost all tissue In the human body, bFGF Is reteased from
`the extracellular matrix once tissue is dama&ee~, and then acts on various cells and tissues to stimulate tissue
`regeneration. While bFGF hasa wide variety of functions, its most prominent features are its powerful ability to
`stimulate cellular proliferation and Its capacity to promote neovasc:ularizatlon.
`
`In 1988, KAKEN obtained eJa:lusiw licensinJ riJhts for recombinant human bFGF (trafermin) in Asia flom Scios Inc., of
`the United States. Following this, KAKEH has pushed forward with Its own MD efforts, and subsequently obtained marketing approval for Flblast
`Spray for the treatment of pA!iSSure ulcers and otller skin ulcers (burn ulcers and leg ulcers) in June 2001. Further, after completing reexamination in
`2010, Fiblast Spnsy bas been re-acknowledged as a highly reliable drug. It is now used with confidence at a number of hospitals throughout Japan.
`
`Not only effective for n!generating skin tissue, trafermln has also demonstrated tile ability to promote tile proliferation and rvgeneratlon of both
`periodontal and bone tissues. In the field of dentistry, trafermin is known for its ability to promote the regeneration of periodontal ligaments,
`cementum, and alveolar bone. KAKEN has completed phase Ill clinical trial for this drug, and are currently In the process of preparing to file a new
`drug application for trafermin to be used in the tn!atment of periodontitis.
`
`In March 2005, KAKEN acquired the worldwide rights to develop, manufacture, and market for all therapeutic purposes. In June 2007, KAKEN
`entered a Ucenslng agreement with sunstar Inc. Nprdlng the development and marketing of trafermln for dental applications In Europe and North
`America. Further, in Nowmber 2009, KAKEN entered a licensing agreement with Olympus Corporation in relation to the development and marketing
`of trafermln for wound healing In Europe and North Ameflca. KAKEN also entered licensing agreements regarding tile development and marketing
`
`1 of 2
`
`10/30/17, 11:17 AM
`
`Page 1 of 2
`
`

`

`R&D Pipeline | Research & Development Division | Business | Kaken P...
`
`http://www.kaken.co.jp/english/business/rd_pipeline.html
`
`of Fiblast Spray with a Chinese phannaceutical company in December 2005 and with a South Korean company in December 2006.
`
`Going forward, KAKEN will continue to expand the presence oftrafermln In the global medical market. In this undertaking, KAKEN will collaborate
`with our 0\leiWiS business partners and fully utilize the wealth of knowledge we have aCQimulated regarding trafermin.
`
`I Kaken's specialty -topical antifungal agent-
`
`Clenafln• (Topical onychomycosis trutment)
`
`Clenafin (efinaconazole) discovered by KAKEN's scientists is the wortd's first triazole compound for a topical
`medication for onychomycosis. This drug has potent antifungal activity and is effective against a wide spectrum of
`fungi. Also,lts effectiveness decrused only slightly compared to other existing antifungal agents In the presence of
`keratin, the main component of nails. This means that the drug has superior nail penetrating properties, the~by
`demonstrating that It can maintain Its therapeutic effect In nails thickened by fungal infection or on the underside of
`such nails. Clenafin has also shown antifungal activity in various animal models of infections and, in particular, greater
`effectiveness than other treatment options in a guinea pig model for onychomycosis. For these reasons, Clenafin is a
`promising new topical treatment for persistent onychomycosis, which has been primarily treated through oral medications In the past.
`
`In 2006, KAKEN conduded a licensing agreement with U.S. company Dow Phannaceutical Sciences, Inc. (DPS), granting it the development and
`marketing rights for Clenaftn In Europe and the Americas. After Canadian company Valeant Pharmaceuticals lntematlona~ Inc., acquired DPS In
`2009, it has continued to mnductjoint clinical development activities with KAKEN.In two multinational pivotal studies (phase Ill) in patients with
`mild to moderate onychomycosis of the toenails, this topical investigational drug was found to be clinically and statistically superior to a vehide for
`all primary and secondary endpoints. The efficacy of this drug Is also competltlw when compared to that of existing oral medications, and It has
`demonstrated its efficacy as a topical agent with fewer side effects.
`
`In 2014, KAKEN was granted manufacturing and martcetlng approval for Clenafln In Japan, and It was subsequently launched that year, making It the
`first topical medication for onychomycosis in the muntry. In the nearly one ~r since its release, Clenafin has an eueptional reputation among
`dennatologlsts. In addition, Valeant acquired marketing approval forth Is drug In the United States and Canada during 2014, and this drug Is being
`marketed under the trade name Jublla In these countries.
`
`KAKEN wilt continue to work with over.as partners to get approval forth is drug's U5e as a treatment for onychomycosis in the global market
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`Page 2 of 2
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