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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.