An exclusive License and Supply Agreement (LSA) has been signed between Fuji Pharma, the leader in women’s health in Japan, and Mithra, a Euronext -listed company specialized in women’s health, for the commercialization of Donesta in Japan and ASEAN territories.
Donesta is Mithra’s Hormone Therapy (HT) candidate for which a dose-finding Phase II study is currently ongoing, with top-line results expected late Q1 2018.
According to the agreement, Mithra is entitled to €1 million upon signature as well as future low double digit million development, regulatory and commercialization milestones.
Furthermore, Fuji Pharma and Mithra or one of its partners will equally fund the development of Donesta Phase III in Japanese subjects in the HT indication. Also, based on the annual minimum order quantities agreed upon, the exclusive supply agreement will provide Mithra’s CDMO2 with a steady flow of production work, and will be a source of recurring revenue for Mithra for the duration of the contract, the company said Wednesday in a press release.