Mithra Pharmaceuticals, a company dedicated to Women’s Health (based in Liege), has signed a binding term sheet for Donesta, its Hormonal Treatment product candidate. The actual market of menopause in Japan represents EUR 42.6 million.

Six months after Mithra announced the signing of a 20-year exclusive license and supply agreement for Estelle with Fuji Pharma, the Japanese leader in Women’s Health and Japanese market leader in contraception and dysmenorrhea, Fuji has now signed a term sheet for its product candidate in menopause, Donesta, as well.

Fuji Pharma obtains the rights to commercialize Donesta in Japan and ASEAN (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Phillipines, Singapore, Thailand and Vietnam).

Under the terms of the agreements, Mithra will, depending on the progress of the development, receive single digit milestones. The term sheet comprises an exclusive supply obligation for the duration of the contract, which would provide Mithra’s CDMO with a steady flow of production work for its Estetrol-based products, and hence represent a source of revenue for Mithra over the entire term.

Furthermore, Fuji Pharma and Mithra Pharmaceuticals or one of its partners will undertake and equally fund the development of Donesta Phase III in Japan in the HT indication.