Mithra Pharmaceuticals SA in €17m licencing deal

Donesta is the first Estetrol-based hormone substitution therapy for the relief of menopausal vasomotor symptoms (VMS). Under a licencing deal with Searchlight Pharma Inc, Belgian Mithra Pharmaceuticals SA can receive up to €17.05m in fees and milestones, along with tiered royalties on annual net sales in the Canadian territory. The deal adds to an agreement to commercialise Donesta, which is due for approval in Q1/2024 following promising Phase III data. In February 2023, Gedeon Richter plc got the commercialisation rights for Donesta in geographical Europe, the CIS countries, Latin America, Australia and New Zealand.

Mithra hit all its co-primary endpoints in a Phase III study conducted in Europe. However, the company missed one of four endpoints in an US trial. The missed endpoint looked at the severity of vasomotor symptoms, the medical term for hot flushes, at Week 4. Mithra said the severity assessment reached statistical significance at Week 5. All the other three co-primary efficacy endpoints, which looked at severity at Week 12 and frequency at weeks 4 and 12, were met in both clinical trials.

Donesta is a new orally administered Estetrol (E4)-based hormone therapy product candidate. E4 is a natural oestrogen, produced only during fetal development; E4 displays a differentiated biological mechanism compared to other oestrogens suggesting that E4 may offer women an improved benefit/risk profile for the treatment of the symptoms of menopause. Donesta is Mithra’s second product to be launched.