Health is our mission

Richter and Mithra strengthen their partnership and signed a license and supply agreement for the commercialization of a novel oral contraceptive to Latin America

12/23/2020

G

edeon Richter Plc. ('Richter') and Estetra S.A, the wholly owned subsidiary of Mithra (Euronext Brussels: MITRA) ('Mithra') today announced that they have extended their partnership and signed a license and supply agreement for the commercialization of a novel 15 mg estetrol (E4) / 3 mg 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 commercia​lization 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 / IQVIA2019) and third (EUR 1 billion / IQVIA 2019) largest world markets 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."


About Richter

Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 3.6 billion (USD 4.1 billion) by the end of 2019, Richter's consolidated sales were approximately EUR 1.6 billion (USD 1.7 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.

 

About Mithra

Mithra (Euronext: MITRA) is a Belgian biotech 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. Its three lead development candidates are built on Mithra's unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment targeting perimenopause and 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 300 staff members and is headquartered in Liège, Belgium. www.mithra.com

​ 

For more information:

Richter

Investors:​ Katalin Ördög:  +36 1 431 5680

Media: Zsuzsa Beke:  +36 1 431 4888​


Mithra

Investors: Jean-Manuel Fontaine : +32 476 96 54 59 – investorrelations@mithra.com

Press: Maud Vanderthommen : +32 473 58 61 04 – press@mithra.com