Mithra, a company focused on Women’s Health, and Searchlight Pharma Inc., a Canadian-specialty pharmaceutical company, entered a licensing agreement for the Canadian rights to Donesta, an investigational medicine for the treatment of menopause symptoms.

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 royalties on Canadian annual sales. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required in Canada.

Donesta is a next generation orally administered Estetrol (E4)-based hormone therapy product candidate with a differentiated biological mechanism that may offer an improved benefit/risk profile for the treatment of the symptoms of menopause.

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 Q3 2021, while Haloette was launched in Q1 2022.

David Horn Solomon, CEO of Mithra, said, “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.”

Mark Nawacki, Searchlight’s President, and CEO, said, “We are very proud of the relationship that we have developed with Mithra, but also about what this says about partnering with Searchlight more broadly. Strong relationships built on trust and backed by results are integral to our strategic focus of bringing innovative products, such as this novel Estetrol-based hormone therapy, to the Canadian market. As a leader in women’s health in Canada, we’re excited to be able to deliver another option to help Canadian women address their unmet needs in managing the symptoms of menopause.”