Mithra and Searchlight Pharma Inc. announced the signing of a binding term sheet for a licensing agreement for the Canadian rights to Donesta®, an investigational medicine for the treatment of the symptoms of menopause. Under the binding terms, Searchlight will have the exclusive sales and marketing rights for Donesta® in Canada. Mithra is eligible to receive up to ?17.05 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. Donesta® is the next generation orally administered Estetrol (E4)-based hormone therapy product candidate. E4 is a unique natural estrogen, produced only during fetal development; E4 displays a differentiated biological mechanism compared to other estrogens suggesting that E4 may offer women an improved benefit/risk profile for the treatment of the symptoms of menopause.

Searchlight has repeatedly ranked among the top-growth companies in Canada, with one of the larger portfolios of women?s health products and associated sales team in the Canadian market. Mithra and Searchlight have a continuing partnership for NEXTSTELLIS®, a combined oral contraceptive product based on Estetrol and HALOETTE®, a vaginal contraceptive ring in Canada. NEXTSTELLIS® was launched in Canada in third quarter 2021, while HALOETTE® was launched in first quarter 2022.

In 2022, Mithra announced topline efficacy results of the Donesta® Phase 3 clinical program, which demonstrated a meaningful reduction in vasomotor symptoms from baseline and compared to placebo, with all co-primary efficacy endpoints met with statistical significance. The two ongoing trials are being carried out in 2,550 postmenopausal women (40-65 years): one in North America (?C302?) and a second at centers in 14 countries in Europe and Latin America (?C301?). Both trials are randomized, multicentre and double-blind.

In March 2023, Mithra announced promising topline safety results from the Donesta® Phase 3 trial in North America (C302). The results will support marketing authorization filings scheduled in the U.S. in second half 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in first half 2024.