Richter to Supply Active Ingredient for Mithra's Estelle, Donesta

Pharma

Image by gedeonrichter.com

Hungarian pharmaceutical company Gedeon Richter on Tuesday announced that it signed a binding agreement to supply Belgian peer Mithra with Estetrol (E4) native estrogen for Estelle and Donesta, according to a report by state news wire MTI.

Estelle is sold as a combined oral contraceptive in the United States and Canada under the brand name Nextstellis and in Europe as Drovelis and Lydisilka. Donesta is a product candidate for orally administered Estetrol-based hormone therapy.

Mithra and Richter have a license and supply agreement for Estelle, concluded for Europe and CIS countries in 2018 and extended to cover 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 mln in regulatory milestones and is eligible for additional tiered sales-related royalties and commercial milestones.

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 mln in upfront payments and is eligible to receive EUR 15m in additional milestone payments and tiered double-digit royalties on sales.

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