Richter and Mithra Sign Supply Agreement

The Hungarian pharma company Gedeon Richter Plc. and Mithra Pharmaceuticals of Belgium have signed a binding supply agreement for the active pharmaceutical ingredient (API) for the combined oral contraceptive Estelle® and Donesta®, a novel product candidate for the treatment of post-menopausal symptoms.

The agreement, announced on the website of the Budapest Stock Exchange, specifies that Richter will manufacture and supply the Estetrol (E4) native estrogen for Mithra’s Estelle® and Donesta®.

As Erik Bogsch, Chairman of the Board of Richter, commented, “we are pleased to expand our collaboration with Mithra through this agreement aiming towards to capitalize on our well-established steroid chemistry knowledge 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, said that “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.