Blockbuster Potential in Perimenopause with new E4 Candidate and Acceleration of Donesta Phase III Program

  • Potential for new perimenopause product candidate PeriNesta launch as early as 2023, with an estimated market opportunity of at least 18 million patients annually in the US and key EU markets
  • Donesta® phase III E4 monotherapy patient recruitment anticipated to start in Q3 2019 pending approvals , potential market authorisation by end 2023
  • Ongoing global patent filings could protect Donesta® and PeriNesta IP estate until 2039

Liège, Belgium, 07 January 2019 – 6:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the further expansion of its Estetrol (E4)-based programs with a decision to target the underserved perimenopausal market, which affects women between reproductive age and post-menopausal age. The Company believes this additional indication for a product with a comparable formulation to E4 15mg/DRSP 3mg represents a major new market opportunity that requires only limited additional investment.

The Company also announced plans to accelerate preparations for its proposed Phase III E4 monotherapy study of Donesta® in menopause. Mithra has appointed leading specialist Contract Research Organization (CRO) ICON Plc (NASDAQ: ILCR) to manage the study and recruitment is expected to begin in the second half of 2019, pending approvals.