November 13,1996 l Press Release | Kaken Pharmaceutical C0.,Ltd.
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`Press Release
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`Antifungal Agent "Mentax" (Butenafine HCI) Approved by FDA
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`Novemberlg, 1996
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`Penederm Inc. ( head office: California, U.S. }, the licensee ofantifungal agent Mentax ( generic name: butenafine HCl ) in the US, informed KAKEN
`PHARMACEUTICAL on October 18 that the drug has obtained FDA approval as an ethical drug.
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`KAKEN concluded a license agreement with Penederm in 1992. The drug was approved as a cream for treating athlete‘s foot.
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`Penederm and Schering-Plough Healthcare Products ( head office: New Jersey, U.S. ] will co~market the product in the US. underthe current
`trademark Mentax startingin January 1997.
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`KAKEN has already licensed Mentax in almost all countries. KAKEN expects that the FDA‘s approval will give momentum to licensing,
`development and governmental approval of Mentax in Asian countries.
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`1.
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`Information on Mentax
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`Mentax (generic name: butenafine hydrochloride) is a new antifungal agentwith a benzylamine structure. Unlike imidazole, Mentax interferes
`with the synthesis of ergosterole in cell membrane components. Because it absorbs through both the epidermis and hair follicles it penetrates the
`stratum corneum and the deep parts ofthe skin, thus exhibiting a very powerful anti»fungai activity against Trichophyton and other superficial
`fungi. Another advantage to this medication is that it only needs to be applied once a day. Mentax has been sold in Japan in liquid and cream forms
`since April 1992.
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`Brand name I
`Generic name 2
`indication :
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`Mentax
`butenafine hydrochloride
`tinea pedis ( athlete's foot)
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`2.
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`information on Penederm
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`Penederm, established in 1987, is specialized in the development and manufacturing oftopical preparations. it has unique proprietary ( drug
`delivery system ) technology and specializes in the area of dermatology.
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`Company name:
`Head office I
`President and CEO :
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`Penederm inc.
`FosterCity, California, USA
`Lloyd H. Malchow
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`3.
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`information on ScheringePlough Healthcare Products, Inc.
`This company is Schering-Plough‘s OTC and personal care products division. Schering—Plough is engaged in the development, manufacture and
`marketing of drugs and healthcare products on a global basis,
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`Company Name C
`Head office 2
`President I
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`Schering—Plough Healthcare Products, inc.
`Liberty Corner, New Jersey, USA
`Donald Conklin
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