25 October 2019
Liege, Belgium, 24 October 2019 – 7 :30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into two exclusive license and supply agreements with Aicore Life Sciences for the registration and commercialization of two major products in contraception and menopause in Eastern Europe: the hormonal contraceptive ring Myring™ and the tibolone-based product Tibelia® for use in Hormone Therapy (HT).
Aicore Life Sciences is an R&D focused pharmaceutical company with headquarters based in the Netherlands. Its founders are former employees of Organon (now Merck), a market leader in women’s health that stood at the forefront of many important developments in this market segment. Aicore pursues the goal of developing an upgraded portfolio of gynecological products. The emphasis is on cutting-edge generics as well as on original products targeting market niches with moderate competition. Its network encompasses the complete range of facilities required for all stages of drug development, distribution, marketing and sales across Western Europe.
Under the terms of these two 15-year agreements, Aicore will be responsible for the registration and distribution of Tibelia® (under the brand name of Aivial™) and Myring™ (under the brand name of Airing™) in Bulgaria, Moldova and Ukraine, in addition to Croatia, Romania and Serbia for Myring™. Mithra will manufacture Myring™ at its Contract Development and Manufacturing Organization (CDMO) facility in Belgium. Globally, this agreement could generate revenues of at least EUR 17.5 million for Mithra.
To date, Mithra has licensed Myring™ to industry leaders in 12 international markets, including the United States, Austria, Czech Republic, Russia, Denmark, Chile, Australia/New Zealand, MENA territories, South America, Germany, Israel and China. In Europe Mithra expects to have 23 marketing authorizations granted. Tibelia® is currently marketed in approximately ten countries through existing license and supply agreements.
François Fornieri, CEO Mithra Women’s Health, commented: “We are pleased to have finalized the agreement with Aicore Life Sciences for the commercialization of our contraceptive and menopausal products in Eastern Europe. With their vision and expertise in women's health, Aicore is the ideal partner to market our products in this region.”
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). Further information can be found at www.mithra.com
About Tibelia® (Aivial™)
Tibelia® is a synthetic steroid (tibolone) intended to be used for hormone replacement therapy. Tibelia is a bioequivalent of Livial® 2.5mg which is a product that mimics the activity of the female sex hormones in the body, and is used especially for the relief of symptoms occurring after menopause. In some countries, this product is also used for the prevention of osteoporosis. It has been demonstrated that tibolone has favourable effects on various tissues in the body, such as brain, vagina and bone.
About Myring™ (Airing™)
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.