The agreement specifies that Richter will manufacture and supply the Estetrol (E4) native estrogen for Mithra’s Estelle® and Donesta®.
Erik Bogsch, Chairman of the Board of Richter, commented: “We are pleased to expand our collaboration with Mithra through this agreement aiming towards to capitalise on our well established steroid chemistry kowledge and API supply capabilities. It is a testament to Gedeon Richter’s deep commitment to the development and commercialization of products to improve quality of life for women across all age groups.”
David Horn Solomon, Chief Executive Officer of Mithra, commented: “This agreement marks a deepening of our strong cooperation with Richter and provides for expansion and improvement of our manufacturing capabilities for Estelle® as sales continue to grow. Our existing marketing agreements are progressing well and will all benefit from Gedeon Richter’s strong experience in women’s health. This new agreement affords us and our distribution partners with a commercially attractive source for our unique active pharmaceutical ingredient; it ensures both profitability as well as prudent redundancy in our supply chain, securing regular and reliable delivery of Estetrol to produce Estelle® and Donesta®.”
Mithra and Richter have a license and supply agreement for Estelle®, concluded for Europe and CIS countries in 2018 and extended it to cover key markets in Latin America in 2020. Under the terms of the European agreement, Mithra received an upfront payment of EUR 35 million and EUR 20 million in regulatory milestones and is eligible for additional tiered sales-related royalties and commercial milestones. Mithra received an undisclosed upfront payment under the Latin America agreement and is eligible for regulatory- and sales-related milestones plus tiered royalties on sales.
Mithra and Richter have a 20-year licensing agreement for Donesta® in Europe, Latin America, Australia and New Zealand. Under the terms of that agreement, signed in February 2023, Mithra received EUR 55 million in upfront payments and is eligible to receive EUR 15 million in additional milestone payments and tiered double-digit royalties on sales. Richter is responsible for supply and production of the product for all its territories.
Estelle®, Mithra’s first E4-based product composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP), is commercialized as a combined oral contraceptive in the US and Canada under the brand name NEXTSTELLIS® and in Europe as DROVELIS® and LYDISILKA®. Donesta® is Mithra’s next generation orally administered Estetrol-based hormone therapy product candidate.
Mithra (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 develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO. Active in more than 100 countries around the world, Mithra has an approximate headcount of 230 staff members and is headquartered in Liège, Belgium. www.mithra.com
NEXTSTELLIS®, LYDISILKA®, ESTELLE® and DONESTA are registered trademarks of Mithra Pharmaceuticals or one of its affiliates.
DROVELIS® is a registered trademark of Richter Gedeon Nyrt.
Gedeon Richter Plc. (www.gedeonrichter.com), Headquartered in Budapest/Hungary, it is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, China, Latin America, and Australia. Having reached a market capitalization of EUR 3.9 billion (USD 4.1 billion) by the end of 2022, Richter's consolidated sales were approximately EUR 2.0 billion (USD 2.1 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System, and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development.
For more information:
Katalin Ördög: +36 1 431 5680
Zsuzsa Beke: +36 1 431 4888
Mithra:David Horn Solomon
Chief Executive Officer
Investor & media relations
+41 79 367 6254