Publication date: 20/11/2018
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that it has entered into an exclusive 10-year license and supply agreement with Neo Health (OTC) Pty Ltd (Neo Health) for the commercialization of its combined hormonal contraceptive vaginal ring in Australia and New Zealand. The vaginal ring, made of ethylene vinyl acetate copolymers (EVA), is known as Myring™ in other markets but will be marketed under a different brand name in Australia and New Zealand.
Under the terms of the agreement, Mithra will receive an undisclosed upfront payment and will be eligible to receive milestone payments and recurring revenues based on minimum annual quantities (MAQ). Mithra will exclusively manufacture the product at its Contract Development and Manufacturing Organization (CDMO) facility in Belgium.
Under the terms of the agreement, following marketing authorization, Neo Health will have the rights to sell the ring in Australia and New Zealand, a contraceptive market valued at approximately EUR 107 million. Neo Health is a full-service pharmaceutical company developing and in-licensing over-the-counter medicines and medical devices as well as complementary, niche and innovative products for the Australia and New Zealand markets. Neo Health also provide assistance with product reviews, business analysis, freedom-to-operate patent clearance searches and product registration for companies wishing to commercialize their medicines/medical devices in these markets.
The agreement in Australia and New Zealand follows a number of licensing deals for Myring™ with market leaders in major territories. In 2017 Mithra announced an exclusive long-term license and supply agreement with Mayne Pharma for the commercialization of Myring™ in the US, as well as further agreements with Gynial, Adamed, Orifarm, Pasteur Laboratorios and Alvogen in Austria, Czech Republic, Denmark, Chile and Russia respectively. Due to these agreements Mithra’s polymer based manufacturing facility has reached full capacity. The Company is now considering further investment in its state of the art CDMO to triple manufacturing capacity and meet additional demand.
François Fornieri, CEO of Mithra Women’s Health, commented: “Australia and New Zealand are important markets wherein demand for products like Myring™ continues to expand. We have now signed seven commercial agreements for Myring™, demonstrating growing global interest from specialist pharmaceutical companies in this product, our polymer-based assets, technological expertise and our cutting edge manufacturing facilities. We look forward to working with Neo Health and offering this new contraceptive option to women in Australia and New Zealand.”
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 nonbiodegradable, 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.
About Neo Health
Neo Health (OTC) Pty Ltd is a full-service pharmaceutical company developing and in-licensing over-the-counter medicines and medical devices as well as complementary, niche and innovative products for the Australia and New Zealand markets. Private-label suppliers to pharmaceutical multinationals and pharmacy chains in Australia and New Zealand.
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 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 CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com