Mithra Signs LSA for Commercialization of Estelle® in North Africa

  • Mithra grants exclusive license to GyneBio Pharma for commercialization of its combined oral contraceptive Estelle® in Algeria, Morocco and Tunisia
  • Deal worth up to EUR 25 million for Mithra over the contract period
  • Agreement follows licensing deals for Estelle® with market leaders in key regions such as U.S., Europe, Australia, South America, ASEAN and Middle East

Liege, Belgium, 19 October 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into an exclusive license and supply agreement with Gynebio Pharma for the commercialization of Estelle® in North Africa. Estelle® is a novel, next generation oral contraceptive product candidate containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile.

Mithra Announces FDA update

  • Mithra’s US partner Mayne Pharma receives complete response letter from FDA for Myring™ requesting additional data that is not normally requested for generic products
  • Based on the information available to date, Mithra expects to have the necessary data in hand to respond to FDA before year-end
  • No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process
  • Mid-cycle review with FDA regarding the New Drug Application (NDA) for Estelle (Nextstellis) raised no substantive issues
  • Solid cash position and funding facilities to cover working capital needs

Liege, Belgium, 6 October 2020 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX: MYX)  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).