Richter and Mithra Receive Positive CHMP Opinion for Estelle®

Budapest, Hungary – Liege, Belgium – 26 March 2021 – 13:15 CET – Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a novel combined oral contraceptive containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). Subject to approval by the European Commission, the marketing authorization valid for all European Union Member States is expected to be granted by the end of the second quarter 2021. The product will be marketed in Europe by Richter under the brand name Drovelis®.

Richter is dedicated to bring to market innovative treatment like Drovelis® that will widen the selection of products within the female contraception solutions”, said Erik Bogsch, Executive Chairman of Gedeon Richter Plc. “We are encouraged by this positive opinion from the CHMP and we shall do our best to make Drovelis® available to physicians and patients in Europe.”

After Estelle® first approval granted in Canada early this month, we are very pleased with this positive opinion given by the European Medicines Agency”, said Leon Van Rompay, CEO of Mithra. “Being able to offer the result of so many years of work to women is a huge achievement for a biotech such as Mithra. It demonstrates the resilience of our teams which, despite of the turbulences caused by Covid-19, managed to take up the challenge with flying colors. We are pleased to collaborate on this exciting project with our long-standing partner Gedeon Richter as this further strengthens our successful partnership.”

Prof Jean-Michel Foidart, Permanent Secretary of the Royal Academy of Medicine of Belgium, added: “We’ve been working on Estetrol, a native hormone produced by the human body during pregnancy, for more than ten years to develop a new generation contraceptive pill with a clear benefit/risk aiming to improve women’s quality of life. This product promises to be a major breakthrough in a space where there hasn’t been any innovation in decades.”

“This new product has an unique profile, significantly supports reproductive health preservation and conscious family planning. Estetrol combined with drospirenone represents a major innovation breakthrough in reproductive health and sets a new horizon for women around the world,” stated Professor Emeritus György Bártfai, the Chairman of the Egon and Ann Diczfalusy Foundation, founded in 2007 to preserve and forward professor’s spirit and legacy for the next generations.