EMA Accepts Richter’s Marketing Authorization Application (MAA) for Estelle®, a Novel Combined Oral Contraceptive

Liege, Belgium, 27 February 2020 – 17:45  CET – 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.

Mithra Announces Commercial Launch of Myring™ in Belgium

  • Mithra’s hormonal contraceptive ring is now available in pharmacies in Belgium under the trademark name Myloop®
  • Large-scaled global commercialization of Myring™, especially in the world’s three largest markets
  • Mithra CDMO in Belgium expected to produce nearly 2 million rings in 2020

Liege, Belgium, 12 February 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of Myring™ in Belgium. The Belgian contraceptive ring market is valued at around EUR 5.1 million, with more than 600,000 rings sold each year. Mithra’s vaginal contraceptive ring is marketed by Ceres Pharma in Belgium under the trademark name Myloop®.

Mithra receives positive ruling on Patent Income Deduction

Liege, Belgium, 10 February 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has received a positive ruling from the Belgian tax authorities, enabling Mithra to benefit from the Belgian Patent Income Deduction (PID) 1 on patent related income arising from Mithra’s E4-based products (Estelle®, Donesta®).