Fuji Pharma to market Mithra's hormone therapy Donesta in Japan and ASEAN


Belgium-based pharmaceutical company Mithra has signed an exclusive license and supply agreement (LSA) with Japanese firm Fuji Pharma for the commercialisation of Donesta in Japan and Association of South-East Asian Nations (ASEAN) territories.

Donesta is a latest hormone therapy (HT) candidate that has entered into a currently ongoing dose-finding Phase II study, with results expected in late Q1 next year.

Under the deal, Mithra is entitled to €1m upon signature, in addition to future low double-digit million development, regulatory and commercialisation milestones.

“As the leader in Women's Health in Japan and our existing partner for Estelle in these territories, Fuji Pharma is our partner of choice for the commercialisation of Donesta.”

Both Fuji Pharma and Mithra or one of its partners will carry out as well as equally fund the development of Donesta Phase III study in Japanese subjects in the HT indication

Last August, the two companies agreed on an exclusive LSA for Estelle, which is Mithra's combined oral contraceptive candidate that is currently in Phase III studies.

Mithra chief executive officer François Fornieri said: “Signing as early as Phase II highlights Fuji Pharma's commitment to the programme.

“As the leader in Women's Health in Japan and our existing partner for Estelle in these territories, Fuji Pharma is our partner of choice for the commercialisation of Donesta.”

The HT markets in Japan and the ASEAN region are valued at approximately €42.6m.

Fuji Pharma is committed to extending the current market with Mithra HT candidate Donesta.