Mithra Continues to Confirm its Contraception Market Leader Position in Belgium

  • Mithra realized its best selling month in June 2016
  • Mithra remains leader in contraception on the Belgian market (in terms of cycles)
  • Mithra becomes N°2 in terms of value ahead of Organon (MSD)
  • The trend in the market confirms Mithra’s Estetrol-based developments

Liège, Belgium 26 July 2016 – In terms of cycles, Mithra announces that it recorded a 2.8%[3] market share growth compared to June 2015. This represents a significant growth given the 1%[4] decrease recorded on the Belgian contraception market over the same period.

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Green Light from FDA for the Launch of Estelle®(E4/DRSP) Phase III Study in the United States

  • Mithra obtains FDA’s approbation for its Investigational New Drug for the Phase III clinical trials of Estelle® (E4/DRSP).
  • This green light paves the way for the clinical trial of Mithra’s Estetrol-based product candidate in contraception in the United States and in Canada.

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Canada Approves Clinical Trial Application for Estelle® (E4/DRSP) Phase III Study

Liège, Belgium 20 July 2016 –  Mithra announces today that the Canadian authorities approved its Clinical Trial Application (CTA) for the Phase III study for Estelle® (E4/DRSP), the Estetrol-based product candidate in contraception developed by Mithra. This great news has been received a few weeks after the enrolment of the first patient in the Phase III study in Europe. Mithra should receive a feedback from the American Food and Drug Administration (FDA) in the next few days, as well as ethic committees, representing the last step before the launch of the Phase III study in the United States and in Canada.

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Mithra Obtains a Marketing Authorisation for its Own Product Tibelia® in Spain for Which it has Two Commercial Agreements

Liège, Belgium 5 July 2016 – Mithra Pharmaceuticals announces today that it obtained a new Marketing Authorisation for the commercialization of its product Tibelia® (bioequivalent of Livial® developed by Mithra) in Spain.

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