Mithra Pharmaceuticals SA and Searchlight Pharma Inc. have signed a License and Supply Agreement for the Canadian rights to DONESTA(R), Mithra's investigational medicine, containing Estetrol, for the treatment of the symptoms of menopause. The signing of the agreement activates a first milestone payout to Mithra of EUR 1.5 million. The two companies signed a binding term sheet for a licensing agreement in July 2023.

Under the terms of the agreement, Searchlight will have the exclusive sales and marketing rights for DONESTA(R) in Canada. Mithra is expected to receive an additional EUR 15.55 million in 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(R) In Canada.

Mithra and Searchlight have a continuing partnership for NEXTSTELLIS(R) combined oral contraceptive product based on Estetrol (ESTELLE(R) project), and HALOETTE(R) vaginal contraceptive ring in Canada (MYRING(R) project). NEXTSTELLIS(R), was launched in Canada in third quarter 2021, while HALOETTE(R). In 2022, Mithra announced topline efficacy results of the DONESTA(R) Phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms from baseline and compared to placebo, with all co-primary efficacy endpoints met with statistical significance.

In March 2023, Mithra also announced promising topline safety results from the DONESTA(R). The results will support marketing authorization filings scheduled in the U.S.S., China, and other key markets.