Mithra Announces Complex Therapeutics Update

  • Positive study results from three-month formulation of Zoreline®, allowing progression to final clinical studies
  • Pivotal trial will commence in Q1 2019, as previously expected
  • Licensing agreement signed with UAE-based ITROM Pharmaceutical Group

Liège, Belgium, 21 December 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces positive results from its three-month PK Zoreline® study, and a licensing agreement for two products with UAE-based company ITROM Pharmaceutical Group (ITROM).

Mithra Announces Myring™ Update

  • Mithra’s US partner Mayne Pharma receives complete response letter for Myring™
  • Increased manufacturing capacity to meet market demand following licensing deals with market leaders in the US, Austria, Czech Republic, Chile, Denmark, Russia, Australia and New Zealand
  • Launch of Myring™ EU production in January 2019

Liège, Belgium, 14 December 2018, 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its US commercial partner Mayne Pharma LLC has received a Complete Response Letter from the US Food & Drug Administration (FDA) related to the abbreviated new drug application (ANDA) for Myring™, the vaginal ring made of ethylene vinyl acetate copolymers (EVA).

Mithra Announces Positive Results of Ovarian Function Sub-Study which Strengthens Estelle® Contraceptive Efficacy Profile

  • Effective ovulation inhibition with no single ovulation at cycles 1 and 3
  • Data further strengthens the contraceptive efficacy profile of Estelle® previously shown in top-line EU/Russia phase III study results
  • Results further support Estelle® as a novel, next-generation combined oral contraceptive for women

Liège, Belgium, 6 December 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced positive results from its ovarian function sub-study for Estelle®, Mithra’s combined oral contraceptive (COC) candidate composed of 15mg Estetrol (E4) and 3mg drospirenone (DRSP). The study forms part of the broader development plan to demonstrate the overall contraceptive efficacy of Estelle®.