Fuji is expecting to launch Estelle in Japan for dysmenorrhea and endometriosis in 2024. Image Credit: SurfsUp / Shutterstock.

Belgium-based Mithra has received €1.25m ($1.37m) from Fuji Pharma as part of a 2016 licence agreement involving Estelle (estetrol-E4 / drospirenone) for Japan and territories in the Association of Southeast Asian Nations (ASEAN).

The payment follows interim reports from the Phase III clinical trials of Estelle for the treatment of dysmenorrhea (Study No. FSN-013P-03) or endometriosis (Study No. FSN-013P-04).

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In February 2023, Fuji reported that the double-blind, placebo-controlled studies met their primary endpoints.

Estelle is a progesterone and oestrogen hormone pill currently marketed in the US, Canada, and Europe for birth control. Fuji is expecting to launch Estelle in Japan for dysmenorrhea and endometriosis in 2024.

Mithra previously received €1.25m following the completion of Phase III Estelle trials in the US and Europe. The company is also in line to receive an additional amount of up to €12.5m under potential milestone-based and supply revenue payments.

Fuji also signed a marketing agreement with Mithra for its second estetrol treatment, Donesta, specific to Japan and the ASEAN region. The agreement also includes co-funding of Phase III Donesta trials for exploring its use as a hormone therapy.

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Mithra reported revenues of €9.3m ($10m) in sales and €4.1m ($4.49m) in out-licencing revenue from Estelle in 2022. The current market cap of Mithra stands at €134.75m ($147.48m).

Other licencing agreements for Estelle include a commercialisation licence with Gedeon Richter in Latin America and marketing agreements with Searchlight in Canada and Mayne Pharma in the US.

Mithra is also developing a colony-stimulating factor 1 receptor (CSF-1R) kinase inhibitor with BCI Pharma for treating endometriosis, oncology, and inflammatory disorders.