Mithra and Searchlight Pharma sign DONESTA® licensing agreement for Canada

Mithra and Searchlight Pharma sign DONESTA^® licensing agreement for Canada

• Mithra to receive EUR 1.5 million milestone payout as a result of the signing of the agreement
• Additional licensing payout of EUR 15.55 million in regulatory and sales milestones, along with tiered royalties on annual net sales
• Searchlight anticipates filing of Canadian regulatory submission for DONESTA^® as a treatment for the symptoms of menopause in H1 2024
• Both companies aim to provide innovative solutions to women by partnering on MYRING^®, ESTELLE^®, and now DONESTA^®.

Liege, Belgium, and Montreal, Canada, 26 October 2023 – 07:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, and Searchlight Pharma Inc. (“Searchlight”), a private Canadian-specialty pharmaceutical company, have signed a License and Supply Agreement for the Canadian rights to DONESTA^®, Mithra’s investigational, next generation 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^® 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.

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About Mithra

Mithra Pharmaceuticals SA (Euronext: MITRA) is a Belgian biopharmaceutical company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Mithra explores the potential of the unique native estrogen estetrol in a wide range of applications in women health and beyond. After having successfully launched the first estetrol-based product in 2021, the contraceptive pill ESTELLE^®, Mithra is now focusing on its second product DONESTA^®, the next-generation hormone therapy. Mithra also offers partners a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) and complex liquid injectables and biologicals (vials, pre-filled syringes or cartridges) at its technological platform Mithra CDMO. Active in more than 100 countries around the world, is headquartered in Liège, Belgium. www.mithra.com

ESTELLE^®, DONESTA^®, MYRING^®, HALOETTE^®, and NEXTSTELLIS^® are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.

About Searchlight Pharma Inc.

Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at www.searchlightpharma.com.

Important information
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

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• 2023-10-26_Mithra_Press release_Searchlight-Donesta_FR