Mithra Announces Estelle® Launch in Belgium
Liege, Belgium, 21 October 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company
dedicated to Women’s Health, is very pleased to announce that its novel combined oral contraceptive
Estelle® is now available in Belgium. The product is marketed in Belgium by Richter under the brand
name Drovelis® and by Ceres Pharma under the brand name Lydisilka®.
Developed by Mithra, Estelle® 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, that is now synthesised from a plant source. In two phase III clinical studies
conducted in 3,725 women, Estelle® showed positive results for primary efficacy and safety endpoints
and achieved positive secondary endpoints including good bleeding profile, cycle control, and
tolerability.
Approved by the European Medicines Agency (EMA) in May 2021, Mithra’s product is the first new
estrogen in a combined oral contraceptive in over half a century. Richter already launched the product
in several European countries, like Germany, Austria, Poland, Hungary, Slovakia and now Belgium.
Currently, the total European contraceptives market is valued at approximately EUR 1.6 billion
annually1
.
Leon Van Rompay, CEO Mithra Women’s Health, commented: “After the successful launch of Estelle
®
in the United States, Canada and several European countries, we are extremely pleased to see the first
estetrol-based product launched in our country where the project started and was successfully
developed. Our teams are particularly proud to see the result of so many years of research and
development now available to patients. Finally, Mithra can provide a real alternative in contraception
to all women.”
Professor Jean-Michel Foidart, Permanent Secretary of the Royal Academy of Medicine of Belgium
and co-founder of Mithra, added: “We’ve been working on estetrol, a native hormone produced by the
human body during pregnancy, for many years to develop and bring a new generation contraceptive
pill with a clear benefit/risk profile 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.”