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.


Please read this carefully as it applies to all persons who visit this website. The following pages contain information relating to an offering and/or admission to trading on a regulated market in relation to securities of Mithra Pharmaceuticals SA ("Mithra Pharmaceuticals"). This information may not be accessed by residents of certain countries based on applicable securities law regulations. Accordingly, if you wish to access this part of the website you must first inform yourself about and then observe the statutory and regulatory requirements applicable to you and to your jurisdiction. In order to establish whether or not you may view the information and documents please read the disclaimer below in full.


This website and the information contained herein or to which it gives access are not intended for, and may not be accessed by, or distributed or disseminated to, persons resident or physically present in the United States of America (including its territories, the "United States"), Australia, Japan or South Africa, and do not constitute, or form part of, an offer or invitation to sell or issue, or a solicitation of an offer or invitation to purchase or subscribe for, nor shall there be any sale or purchase of, any securities of Mithra Pharmaceuticals in the United States, Australia, Japan or South Africa or in any other jurisdiction in which such offer, invitation, solicitation, sale, issue, purchase or subscription would be unlawful prior to registration, unless an exemption from registration or qualification under the securities laws of any such jurisdiction is applicable. The securities of Mithra Pharmaceuticals referred to on this website have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered or sold in the United States absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act. There will be no public offering of Mithra Pharmaceuticals' securities in the United States.

All persons residing outside of the United States, Australia, Canada, Japan and South Africa who wish to access the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. Mithra Pharmaceuticals assumes no responsibility if there is a violation of applicable law and regulations by any person.

No action has been taken by Mithra Pharmaceuticals that would permit an offer of Mithra's securities or the possession or distribution of the materials to which this website gives access or any other offering or publicity material relating to Mithra's securities in any jurisdiction where action for that purpose is required.

Mithra Pharmaceuticals has not authorised any public offering in any Member State of the European Economic Area. With respect to any Member State of the European Economic Area that has implemented Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time (together with any applicable implementing measures in such Member State, the "Prospectus Regulation"), this website and the information contained herein, or to which it gives access, is only addressed to, and is only directed at, qualified investors in that Member State within the meaning of the Prospectus Regulation.

In addition, in the United Kingdom, this website and the information contained herein, or to which it gives access, is addressed to, and directed only at: (a) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), and (b) high net worth entities, and other persons to whom they may otherwise lawfully be communicated, falling within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). In the United Kingdom, any investment or investment activity to which this website and the information contained herein, or to which it gives access, relates, is available only to Relevant Persons and will be engaged in only with Relevant Persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this website and the information contained herein, or to which it gives access.

If you are not permitted to view materials on this website or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Access to electronic versions of these materials is being made available on this webpage by Mithra Pharmaceuticals in good faith and for information purposes only.

By checking the acceptance box below, you confirm and certify that: You are not a resident of or physically present in the United States, Australia, Canada, Japan or South Africa or any other restricted jurisdiction, and that you are either: (a) a resident of, and domiciled in, a Member State of the European Economic Area and a qualified investor within the meaning of the Prospectus Regulation, (b) a resident of, and domiciled in, the United Kingdom, a qualified investor within the meaning of the Prospectus Regulation and a Relevant Person, or (c) otherwise authorised to access this information pursuant to applicable laws or regulations.