Mithra and Searchlight Pharma sign DONESTA® licensing agreement for Canada

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® 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® in Canada.

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® 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® in Canada.

David Horn Solomon, Chief Executive Officer of Mithra said, “The finalization of the DONESTA® licensing agreement for Canada is another important milestone as we continue to deliver on Mithra’s strategy and unlock the value in our business. We are delighted to strengthen our partnership with Searchlight, which is well-positioned to launch the product and provide patients in Canada access to this differentiated-therapeutic candidate. We also continue to have active discussions with multiple parties, as we consider DONESTA® marketing partners for the U.S., China, and other key markets.”

Searchlight has repeatedly ranked among the top-growth companies in Canada, with one of the largest portfolios of women’s health products and associated sales team in the Canadian market. Mithra and Searchlight have a continuing partnership for NEXTSTELLIS® the first Estetrol (E4) based combined oral contraceptive product (ESTELLE® project), and HALOETTE® vaginal contraceptive ring in Canada (MYRING® project). NEXTSTELLIS® was launched in Canada in Q3 2021, while HALOETTE® was launched in Q1 2022.

“We are pleased to continue our relationship with Mithra through the signing of the license agreement for DONESTA®,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “This is the third licensing arrangement we have completed with Mithra. Their ongoing confidence in Searchlight confirms that we provide the optimal commercial platform for our partners to ensure that each product gets the support it needs to succeed. An unwavering commitment to improve women’s health in Canada has been at the core of Searchlight’s mission since its inception. Particularly now, when the attention and focus on the unmet need around the menopause and its impacts on quality of life is being so openly highlighted and discussed in our society, we are proud to be in a position to deliver DONESTA®, a new and truly innovative option, to help Canadian women address their unmet needs in managing the symptoms of menopause.”

In 2022, Mithra announced topline efficacy results of the DONESTA® 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® Phase 3 trial in North America (C302). The results will support marketing authorization filings scheduled in the U.S. in H2 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in H1 2024