Mithra, the women’s health sepcialist, has announced that the Mithra CDMO1 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’s originator product, Nuvaring, will go off patent in April 2018, allowing other products, such as Myring, 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 Myring 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 Myring in the US.
François Fornieri, CEO of Mithra, commented: "GMP approval of our manufacturing line is an important milestone for our vaginal contraceptive Myring 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.”