Gedeon signs deal with Mithra for commercialization of Donesta

Hungarian drugmaker Gedeon Richter (RICHT: HB) has signed a binding term sheet (BTS) with Belgian women’s health care company Mithra Pharmaceuticals (Euronext Brussels: MITRA) for the commercialization of Donesta, an estetrol-based product candidate for hormone replacement therapy in postmenopausal women.

The territories covered by the BTS are geographical Europe, including Russia and CIS countries, Latin America, Australia and New Zealand. The parties intend to finalize their partnership in an agreement during the first quarter 2023.

Donesta is Mithra’s next generation orally-administrated estetrol (E4)-based hormone therapy product candidate offering a potential long-term solution for treating different symptoms of menopause. Early 2022, Mithra announced positive top-line efficacy results of Donesta Phase III Program, which demonstrated a meaningful reduction in vasomotor symptoms (VMS) from baseline and compared to placebo with all co-primary efficacy endpoints statistically met.