Publication date: 13/02/2019
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that its development and production center has successfully produced its first commercial batch of Myring™ for the European market. This first order of the vaginal contraceptive ring will be sold in the Czech Republic, a market worth approximately EUR 1.3 million. This production follows a 10-year non-exclusive license and supply agreement with the Polish company Adamed Group (Adamed) in December 2017.
In accordance with the schedule, the Mithra CDMO production and development center will start manufacturing the other commercial batches for the European market (Austria, Denmark, Belgium, Luxembourg and the Netherlands) in the second half of 2019. In the meantime, the manufacturing process will be ramped up to meet orders placed and the expected market increase. To this end, Mithra has acquired new equipment to triple its production capacity. This cutting-edge equipment will produce new test batches of Myring™ to support the FDA's request for the commercialization by Mayne Pharma in the U.S..
Mithra has licensed Myring™ to leaders in eight major markets, namely the United States, Austria, the Czech Republic, Russia, Denmark, Chile, Australia, New Zealand and, recently, the MENA territories. All these contracts provide for the production of vaginal contraceptives at the Mithra CDMO facility.
François Fornieri, CEO Mithra Women’s Health, commented: « With the production of this first commercial batch on time, we have reached a major milestone that allows us to confirm the commercial production phase for the various markets. With its new state-of-the-art infrastructure, our Mithra CDMO development and production center has demonstrated its expertise and know-how in the manufacturing of complex therapeutics. We are ready to start production of the next commercial batches in the second half of the year. We remain confident about the Myring™ commercial outlook in the U.S. Based on the latest market information, our vaginal contraceptive ring should be among the first generic Nuvaring® products on the U.S. market. »
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women’s Health, with a particular focus on contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra’s unique native estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com