• Myring™ regulatory approvals in Europe and the US expected in 2018
• Regulatory submission follows recent European GMP approval for Myring™ production at Mithra CDMO
Liège, Belgium, 17 July 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has filed Myring™ for marketing approval in Europe. Myring™ is Mithra’s version of Nuvaring™, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). The global market for Nuvaring™ amounts to approximately USD 960 million, with over 75% of sales in the US.[1]
In May 2017 Mithra received Good Manufacturing Practice (GMP) approval for the production line of Myring™ at its Mithra CDMO[2]. This followed a license and supply agreement with Mayne Pharma for the commercialization of MyringTM in the US. Mithra has also signed its first European commercialization agreement, with Gynial in Austria, and is in discussions with other companies for additional geographies.
Pending regulatory approval, Myring™ is on track to be launched in Europe from Q2 2018, following Nuvaring’s™ patent expiration in April 2018. Mayne Pharma is expected to submit the US marketing authorization application for Myring™ in Q4 2017, with US approval expected in H2 2018 and launch shortly thereafter.
François Fornieri, CEO of Mithra, commented: “The filing of Myring™ for commercial approval in Europe is another key step in bringing this additional contraceptive option to market, and we also look forward to our partner Mayne Pharma seeking approval in the US later this year. Building on the partnerships announced to date, we are in discussions with potential partners in a number of additional territories, which should provide an important source of revenue for the Company following the anticipated launch and roll out of Myring™ from 2018.”
