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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®.”

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®, 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.

“Donesta® is the third licensing arrangement we have completed with Mithra,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “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.”

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 H2 2023 and in Canada in 2024. Primary safety data are anticipated for Europe in H1 2024.

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