The study results reconfirm that Myring is bioequivalent to Nuvaring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers.
mithra announces positive OUTCOME of myring(TM) COMMERCIAL BATCH bioequivalence study
- Bioequivalence study performed on commercial Myring(TM) batch produced at Mithra CDMO
- Data will form part of planned Myring(TM) FDA filing by US partner Mayne Pharma
Liège, Belgium, 17 November 2017 - Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces the successful outcome of a confirmatory bioequivalence study performed on a commercial batch of Myring(TM) produced at the Mithra CDMO[1]. The study results reconfirm that Myring(TM) is bioequivalent to Nuvaring®, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).
The study was performed following the tech transfer of Myring(TM) to Mithra’s CDMO facility in early 2017. Mayne Pharma, Mithra’s US partner, is progressing regulatory preparations to ensure a timely submission to FDA in the next few months, and correspondingly efficient approval and commercial launch timelines for Myring(TM). As a reminder, in February 2017, Mithra closed a 10-year exclusive LSA with Mayne Pharma for an upfront of EUR 2.4 million, milestones of at least EUR 10 million following FDA approval and important revenues based on the minimal annual quantities and manufacturing forecasts at the Mithra CDMO. The global market for Nuvaring® amounts to approximately USD 970 million (CAGR: 7.1%), with nearly 80% of sales in the US[2], making this a key territory for Myring(TM).
These latest bioequivalence data will also be used to supplement the Myring(TM) European marketing approval application (MAA), which was already submitted to the European authorities in July 2017. In May 2017, Mithra received Good Manufacturing Practice (GMP) approval for the production line of Myring(TM) at the Mithra CDMO.
François Fornieri, CEO of Mithra, commented: “We are very pleased with the results of the commercial production bioequivalence study, which confirms the previously generated bioequivalence data and demonstrates the expertise of our R&D and CDMO team. With today’s results, our US partner Mayne Pharma can prepare for FDA submission based on a very extensive file, which may allow for a swift approval and market launch in this important territory.”
