Publication date: 20/07/2018
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the company obtained its first marketing authorization (MA) for Myring™ in the UK, following approval by the MHRA . Myring™ is Mithra’s contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA) and is developed to be fully bioequivalent to Merck’s Nuvaring®. In April 2018, Nuvaring® went off patent in both the US and Europe. In the UK, which is a market worth approximately EUR 1.2 million , no generic competition exists as of yet.
Under the same decentralized procedure, in coming months, additional MA’s should be received for Croatia, Hungary, the Czech Republic, Poland, Latvia, Slovakia, and Slovenia, with further MA’s expected in Europe as well as the US later this year and early 2019.
François Fornieri, CEO Mithra Women’s Health: “We are very pleased to obtain the first marketing authorization for Myring™. This is a great achievement for our team, highlighting our expertise in polymer technology and the manufacturing capabilities at our state-of-the-art CDMO facility. We are confident to receive MA’s in additional territories, including for the key US market, later this year or early 2019, and look forward to producing Myring™ for our partners at our CDMO.”
Myring™ is developed to be a generic of Nuvaring® vaginal ring. Nuvaring®’s patent expired in April 2018 both in the US and in EU. Myring™ (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases, in line with the originator (Nuvaring®), on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.
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 a 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 and is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com