Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that the European Authorities has approved two noteworthy modifications relating to the change in the shelf-life and storage conditions of its vaginal contraceptive ring Myring™.
The shelf-life of Myring™ has been extended from 18 to 24 months, and the requirement for special storage conditions has been lifted. Previously, as the originator product, Myring™ needed to be refrigerated prior to the dispensing to the patient, at a temperature between 2 °C and 8 °C. This advantageous modification reduces the impact on transport and storage costs, suppressing the need for cold chain storage. Furthermore, it provides a more convenient option for the distributors, pharmacists and patients.
François Fornieri, CEO Mithra Women’s Health, commented: “We are very pleased that the European authorities have approved these significant amendments to the Myring™ label. The increased shelf-life, in addition to the removal of the requirement for special temperature storage, provides a clear advantage vis-à-vis competitor products. By eliminating the special temperature requirement, supply chain logistics of the product are greatly simplified, and costs reduced. Mithra will seek to obtain the same labeling in the US, where there is not yet any generic competition. This conservation benefit, which is highly anticipated by the market, should enable us to increase our sales volumes in Europe.”
Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment for perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.
Active in more than 85 countries around the world, Mithra has an approximate headcount of 250 staff members and is headquartered in Liège, Belgium. www.mithra.com
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.