Richter and Mithra sign binding Heads of Terms for commercialization of Donesta®

Budapest, Hungary Liege, Belgium 20 December 2022 – 7:30 CET – Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”) today announced that they have signed a Binding Term Sheet (BTS) for the commercialisation of Donesta®, an estetrol-based product candidate for Hormone Replacement Therapy in postmenopausal women. The territories covered by the BTS are geographical Europe, including Russia and CIS countries, Latin America, Australia and New Zealand. The parties intend to finalise their partnership in an agreement during the first quarter 2023.

Donesta® is Mithra’s next generation orally-administrated estetrol (E4)-based hormone therapy product candidate offering a potential long-term solution for treating different symptoms of menopause. Early 2022, Mithra announced positive top-line efficacy results of Donesta® Phase 3 Program, which demonstrated a meaningful reduction in vasomotor symptoms (VMS) from baseline and compared to placebo with all co-primary efficacy endpoints statistically met.

Under the terms of the agreement, Mithra is eligible to receive EUR 55 million in upfront payment – EUR 5 million upon signature of the binding Head of Terms and EUR 50 million upon signature of the License and Supply Agreement –, as well as EUR 15 million in additional milestone payments subject to specific regulatory achievements and tiered low double-digit royalties depending on net sales’ evolution throughout time. Richter will be responsible for the commercialization of Donesta® in about 90 territories through an exclusive license in Europe, Russia, Central Asia, Latin America and through a semi-exclusive license in Brazil – which represents 40% in value of the hormonal menopause market in Latin America –, Australia and New Zealand.

We are honored to materialize a second agreement with Mithra to develop further the Estetrol (E4) native estrogen platform discovered by Egon Diczfalusy at Karolinska Institute and being developed by Mithra Research”, said Erik Bogch, Chairman of the Board of Richter. “Richter is a leading company in Women’s Health and second largest in Europe with affiliates in more than 90 countries including LATAM, Australia and New Zealand. In the Territory, we are reaching out to over 70 % of the Gynecologists universe.”

Drovelis®, Ryeqo®, Bemfola® and Evra® all helped to strengthen Richter’s innovative Women’s Healthcare pipeline covering almost all age groups of the female population. The Estetrol containing product for the management of menopause will assist millions of women in demand of better treatment options”, added Gábor Orbán, CEO of Richter.

Leon Van Rompay, CEO Mithra Women’s Health, commented: “We are very pleased to announce this new agreement with Gedeon Richter, our long-standing partner for the commercialisation of our contraceptive pill Drovelis® in Europe and Russia. This agreement is perfectly in line with our successful collaboration on this first estetrol-based product. We are convinced that they are the best possible partner for the commercialization of Donesta® in these territories and they will deploy the necessary resources to unlock Donesta®’s tremendous potential and to become market leader.”

VMS, characterized by hot flushes and/or night sweats, are common symptoms of menopause and can have a disruptive impact on women’s daily activities and overall quality of life.  Worldwide, more than 50% of women 40 to 64 years of age experience VMS, with 55% having moderate to severe VMS.  Menopause symptoms are severely impacting menopausal women with 83% of women highlighting menopause negatively affected their work with nearly one in two women considering to retire or taking a break from work.

Professor Wulf H. Utian, founder of the North American Menopause Society (NAMS), commented: “The North American Menopause Society recent guidelines reinforced hormone therapy as the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause while slowing bone loss and demonstrating fracture prevention. Estetrol (E4) clinical results to date point towards the biggest advance in post-menopausal estrogen development in almost 100 years. Upon study completion and approval it should add a novel and natural treatment option for clinicians and women to address estrogen deficiency consequences related to the menopause.”


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.