Mithra Pharmaceuticals has signed an agreement with Japanese company Fuji Pharma to commercialise its hormonal treatment (HT) product candidate, Donesta, in Japan and Asean.

The term sheet consists of a supply obligation for the duration of the contract, which is set to provide Mithra’s CDMO with a flow of production work for its Estetrol-based products.

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Fuji Pharma and Mithra will also undertake and equally fund the development of Donesta Phase III in Japan in the HT indication.

Mithra Pharmaceuticals CEO François Fornieri said: “The menopause market is indeed not only bursting out, but it also significantly differs from the contraception market and varies according to the different regions worldwide.

“That is the reason why Mithra chose to reinforce its file with a more qualitative Phase II that could be suitable for all global markets.

“Donesta Phase II will allow Mithra to find reliable partners that would develop their own Phase III, in accordance with regulatory and commercial requirements on the markets they target.”

“Donesta Phase II will allow Mithra to find reliable partners that would develop their own Phase III, in accordance with regulatory and commercial requirements on the markets they target.”

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After completing discussions with regulatory agencies, Mithra has decided to expand the protocol for the study and amend patient exclusion criteria.

The new protocol is expected to secure regulatory approval towards the end of the first quarter of this year.

The Phase II study is slated for completion next year.

Donesta entered into a Phase II dose-ranging study in Europe. As part of the study, 225 patients will be recruited in the Czech Republic, Poland, Belgium, the Netherlands and the UK, for a treatment period of 12 weeks.

The trial is aimed at identifying the minimum dose required to treat vasomotor menopausal symptoms (VMS), or hot flushes.