Mithra signs licensing deal for Donesta in Canada

Belgian women’s healthcare company Mithra Pharmaceuticals (Euronext Brussels: MITRA) saw its shares gain 13.9% to 1.96 euros, after it revealed it has signed licensing agreement with privately-held Canadian specialty pharma firm Searchlight Pharma for the Canadian rights to Donesta, an investigational estetrol-based product candidate for hormone replacement therapy in postmenopausal women.

Searchlight will have the exclusive sales and marketing rights for Donesta in Canada. In return, Mithra is eligible to receive up to 17.05 million euros ($18.8 million) in licensing fees and regulatory and sales-related milestone payments, plus tiered double-digit royalties on total Canadian annual net sales. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell Donesta in Canada.

In March 2023, Mithra announced promising top-line safety results from the Donesta Phase  trial in North America (C302). The results will support marketing authorization filings scheduled in the US in second-half 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in first-half 2024.