Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce that the Mithra CDMO has received Good Manufacturing Practice (GMP) approval for the production line of Myring™, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).
Following the GMP approval by AFMPS, the Belgian Federal Agency for Medicines and Health Products, Mithra will be able to ship its first commercial batches in the European Union once marketing approval has been received. The Company is on track to file for marketing approval in both Europe and the United States in Q2 2017.
Myring’sTM originator product, NuvaringTM, will go off patent in April 2018, allowing other products, such as MyringTM, to enter the US and European market. The vaginal ring market in Europe and the US is valued at EUR 143m and EUR 740m2 respectively.
Mithra recently announced a 10-year license and supply agreement with Gynial GmbH, for the commercialization of MyringTM in Austria. This followed news in February of an exclusive long-term license and supply agreement with Mayne Pharma, a leading specialty pharmaceutical company, for the commercialization of MyringTM in the US.
François Fornieri, CEO of Mithra, commented: "GMP approval of our manufacturing line is an important milestone for our vaginal contraceptive MyringTM as well as for Mithra’s manufacturing and development capabilities at our dedicated CDMO. We already have an excellent partnership in the US with Mayne Pharma and recently announced a further licensing agreement for MyringTM in Austria. Today’s GMP accreditation will further assist ongoing discussions with potential licensing and distribution partners in Europe and other key markets.”
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women’s health, with a particular focus on fertility, 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 natural 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 Mithra CDMO. Mithra was founded in 1999 as a spin-off of 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