Press Release

Antifungal Agent “Mentax” ( Butenafine HCl ) Approved by FDANovember 13, 1996

 Penederm Inc. ( head office: California, U.S. ), the licensee of antifungal 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.

 

 KAKEN concluded a license agreement with Penederm in 1992. The drug was approved as a cream for treating athlete’s foot.

 

 Penederm and Schering-Plough Healthcare Products ( head office: New Jersey, U.S. ) will co-market the product in the U.S. under the current trademark Mentax starting in January 1997.

 

 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.

 

1.   Information on Mentax
 Mentax ( generic name: butenafine hydrochloride ) is a new antifungal agent with 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 of the skin, thus exhibiting a very powerful anti-fungal 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.

 

Brand name :
Mentax
Generic name :
butenafine hydrochloride
Indication :
tinea pedis ( athlete's foot )

 

2.   Information on Penederm
 Penederm, established in 1987, is specialized in the development and manufacturing of topical preparations. It has unique proprietary ( drug delivery system ) technology and specializes in the area of dermatology.

 

Company name :
Penederm Inc.
Head office :
Foster City, California, USA
President and CEO :
Lloyd H. Malchow

 

3.   Information on Schering-Plough 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.

 

Company Name :
Schering-Plough Healthcare Products, Inc.
Head office :
Liberty Corner, New Jersey, USA
President :
Donald Conklin

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