Publication date: 25/04/2019
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into an exclusive license and supply agreement with the pharmaceutical group Megalabs for the commercialization of its vaginal contraceptive ring Myring™ in Latin America and South America. Based in Uruguay, Megalabs develops a wide range of market-leading pharmaceutical products in twenty Latin American countries.
Under the terms of this ten-year agreement, Megalabs will distribute Myring™ in Argentina, Paraguay and the Dominican Republic. In Argentina alone, the market for contraceptive rings accounts for EUR 1.4 million a year1, and is rapidly growing. Mithra will receive an undisclosed upfront payment and will be eligible to receive milestone payments and recurring revenues based on minimum annual quantities (MAQ). Moreover, Mithra will manufacture the product at its Contract Development and Manufacturing Organization (CDMO) facility in Belgium.
To date, Mithra has licensed Myring™ to industry leaders in nine international markets, including the United States, Austria, Czech Republic, Russia, Denmark, Chile, Australia/New Zealand, the MENA territories2 and the Argentinean/Uruguay/Dominican Republic zone. All these contracts provide for the production of Myring™ at the Mithra CDMO, which has tripled its production capacity to meet orders placed, and the expected market increase. The production phase of the commercial batches for the European market was successfully launched in early 2019 and will continue in the second half of the year. In Europe, Mithra has eight Marketing Authorizations for Myring™, including the United Kingdom, Latvia, Hungary, Croatia, Czech Republic, Poland, Slovakia and Slovenia.
François Fornieri, CEO Mithra Women’s Health, comments: “We are pleased to have formed a partnership with Megalabs for the commercialization of Myring™ in Latin and South America. Together with the contracts for the American and Chilean markets, Mithra is strengthening its presence in America, where the growth of the vaginal contraceptive market is significant. This agreement with Megalabs brings us one step closer towards penetrating key international markets and demonstrates the growing global interest from specialist pharmaceutical companies in this product, our polymerbased assets, technological expertise and our state-of-the-art manufacturing facilities.”
Myring™ is developed to be a generic of Nuvaring® vaginal ring, still under patent protection up to 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 contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its three lead development candidates – a fifth generation oral contraceptive Estelle®, the first complete oral treatment for perimenopause PeriNesta™ and next-generation
hormone therapy Donesta® - are built on Mithra’s unique native estrogen platform, E4 (Estetrol). Mithra also develops and manufactures complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at www.mithra.com