Mithra and Searchlight Pharma Announce Donesta Licensing Agreement for Canada

Mithra and Searchlight Pharma Announce Donesta Licensing Agreement for Canada

• Mithra to receive up to €17.05 million in licensing fees and regulatory and sales milestones, along with tiered royalties on annual net sales
• Promising topline safety results from the Donesta Phase 3 trial in North America
• Searchlight Pharma anticipates filing of Canadian regulatory submission in H1 2024

Liege, Belgium and Montreal, Canada, 31 July 2023 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health and Searchlight Pharma Inc. (“Searchlight”), a private Canadian-specialty pharmaceutical company, today 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.

David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are very pleased to reach this agreement with Searchlight Pharma for the licensing of Donesta in Canada. As a Canadian company with extensive experience in women’s health, Searchlight is ideally positioned to ensure optimized launch to provide rapid access to this differentiated-therapeutic candidate and generate maximum value for our shareholders. We continue to have active discussions with multiple parties, as we seek an optimal partner for U.S. marketing rights for Donesta.”