EMA Accepts Richter’s Marketing Authorization Application (MAA) for Estelle®, a Novel Combined Oral Contraceptive
Liege, Belgium, 27 February 2020 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that the European Medicines Agency (EMA) has accepted Gedeon Richter’s (hereinafter: “Richter”) regulatory submission for Estelle®, a combined oral contraceptive containing estetrol (E4) and drospirenone.
Developed by Mithra, the product candidate is composed of 15 mg estetrol (E4), a unique native estrogen and 3 mg drospirenone. E4 is produced by the human fetus, passing the maternal blood at relatively high levels during pregnancy. In two phase III clinical studies conducted in 3,725 women, E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.
According to the relevant license agreement, Richter will commercialize the product in Europe, Russia and other CIS countries.
Graham Dixon, Chief Scientific Officer of Mithra Women’s Health, commented:
“The submission to the EMA marks a significant step toward commercialization of Estelle® in Europe. With this submission we are on-track for potential market authorization in H1 2021. Estelle® promises to provide women with a new choice in oral contraception, combining efficacy with a much improved safety profile. In a space where there hasn’t been any innovation in decades, this will be a major breakthrough.”
Over Mithra
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