Gedeon Richter Plc. (‘Richter’) and Estetra S.A, the wholly owned subsidiary of Mithra, announced that they have extended their partnership and signed a license and supply agreement for the commercialization of Estelle®, a novel 15 mg estetrol (E4) / 3 mg drospirenone containing combined oral contraceptive, in order to include key markets in Latin America. The product candidate is considered a novel oral contraceptive with natural, native estrogen acting selectively in tissues combined with additional benefits of drospirenone.
Richter and Mithra are currently already partnered for the commercialization of this novel oral contraceptive in Europe and in Russia.
Under the terms of the agreement Richter will distribute Mithra’s product in key markets in Latin America (Mexico, Chile, Colombia, Peru and Ecuador) with an option for other markets except for Brazil and Argentina. Richter shall make upon signature of the contract an upfront payment. Additional milestone payments shall be made depending on the progress of the regulatory process of the product. Besides, further sales related milestones will become payable to Mithra subsequent to the launch of the product. Moreover, Mithra and Richter agreed on minimum annual quantities and Mithra will receive tiered royalties on net sales. Currently, Europe and Latin America are respectively the second (EUR 1.6 billion) and third (EUR 1 billion) largest hormonal contraceptive markets in the world in terms of value, behind the United States.
“We remain committed to the development and commercialization of Women’s Healthcare products aiming towards the improvement of the quality of life for the female population in all age groups. This transaction is considered to be a further strategic move to strengthen Richter’s direct position in Latin America and at the same time to become gradually a global Women’s Healthcare player”, said Erik Bogsch, Chairman of Richter.
François Fornieri, CEO Mithra Women’s Health, commented: “We are very pleased to have consolidated our partnership with Richter for the marketing of our new oral contraceptive in the 2nd and 3rd largest markets in the world. Richter's teams have already been involved since 2018 in the deployment of Estelle®'s global marketing strategy and have deployed all the necessary commercial tools and resources in recent months to jointly achieve our ambitious goals. With the planned global launch of our contraceptive only months away, we are delighted to have the best possible partners in all major territories.”