• French MA completes decentralized procedure with MAs granted in 15 European countries
  • Tibelia® is currently marketed in a number of countries through existing supply and license agreements
  • Further agreements and product launches anticipated in 2017

Liège, Belgium, 29 May 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has received a Marketing Authorization (MA) for the commercialization of Tibelia® in France. The French MA completes the decentralized procedure started in 2016, with MAs now granted in 15 European countries.

  • On track to file for marketing approval of hormonal contraceptive Myring™ in EU and US in Q2 2017
  • Approval ensures Mithra fully prepared to ship first commercial batches in Europe

Liege, Belgium 23 May 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce that the Mithra CDMO has received Good Manufacturing Practice (GMP) approval for the production line of Myring™, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).

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  • Mithra grants non-exclusive 10-year license for vaginal contraception ring MyringTM to Gynial GmbH for commercialization in Austria
  • Agreement follows US license granted to Mayne Pharma
  • MyringTM to be manufactured at Mithra CDMO
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  • First step toward bringing Estelle® to the Japanese and ASEAN markets with partner Fuji Pharma
  • Bridging study aims to characterize and compare the pharmacokinetic (PK) profile of Estetrol (E4) and its combination with Drospirenone (DRSP) in Japanese and Caucasian subjects
  • Liège, Belgium May 12, 2017 – Mithra, a company dedicated to Women’s Health, announces that the Company received IRB[1] approval for the launch of a PK ethnobridging study for Estelle®. Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg E4, its unique native estrogen, and 3 mg DRSP. Currently, pivotal Phase III Estelle® trials are ongoing in the US and Canada as well as in Europe and Russia.

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