Mithra, a company dedicated to Women’s Health, is pleased to announce that the Russian Medicines Agency (Roszdravnadzor) has approved the registration application for the novel combined oral contraceptive Estelle® containing 15mg estetrol (E4) and 3 mg drospirenone (DRSP).
Developed by Mithra, Estelle® is the first and only pill containing estetrol (E4), a naturally occurring native estrogen produced in the human body during pregnancy. Synthesized from plant-based sources, E4 has a unique mechanism of action that displays tissue selective activity. 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. Recognized as a New Active Substance (NAS) by the European Medicines Agency, estetrol will be the first native estrogen available in any contraceptive in Russia.
The product will be marketed in Russia by Gedeon Richter under the brand name Esteretta®. Currently, the Russian contraceptives market is valued at approximately EUR 190 million annually with an average growth of 3% per year. Russia represents the third largest market in Europe, after Italy and Germany.
Leon Van Rompay, CEO Mithra Women’s Health, commented: “After Canada, the United States and Europe, we are delighted to obtain an additional market authorization for our first Estetrol-based product, Estelle®. Within a few months, we succeeded in obtaining marketing authorizations covering more than 80% of the contraceptive global market. It's pretty exciting for a biotech to see its product get its marketing approvals on time and make it available to women around the world