Mithra’s European Advisory Board for Estelle Will Meet During the ESC Congress (European Society of Contraception) in Basel on May 4th 2016

  • Mithra has set up a scientific committee composed of international experts to support the last development steps of Estelle®, its contraceptive product candidate based on Estetrol.
  • The European or American scientific committees, set up by Mithra and its own scientific committee, are aimed at gathering impressions and recommendations from the international experts in the contraception field. These committees will be moderated by Mitchell Creinin, global expert in contraception of the Davis University in Sacramento, California.
  • During the ESC (European Society of contraception) held in Basel from May 5th to 7th, 2016, Mithra will gather its experts and practitioners board and will present the last results of the project Estelle to the scientific community during a symposium entitled “Estelle, new contraceptive pill with fetal estrogen, Estetrol”

Liège, Belgium, 3 May 2016 – In order to support the last development steps and to prepare its candidate product for a future introduction on the market, Mithra set up an international and European advisory committee. Composed of 7 international European experts in gynecology, this committee will advise Mithra on its development, but also on the clinical relevance and the added value of Estetrol in the contraception field. These Key Opinion Leaders will work with Mithra in order to confront development plans with market needs. The next committee meeting is planned on May 4th in Basel, Switzerland, during the ESC Congress (European Society of contraception and Reproductive Health) and will be moderated by Mitchell Creinin, a world expert in contraception.

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3 Out of 5 European Countries Selected Have Fully Approved Protocol of Phase II Clinical Study Donesta®-Mit-Do001-C201. 8 Out of 9 European Countries Selected Have Fully Approved Protocol of Phase III Clinical Studies Estelle®- Mit-Es001-C301.

  • The authorities of 3 out of 5 countries give green light to start the Phase II clinical study of the Estetrol-based product candidate dedicated to vasomotor menopausal symptoms (VMS) treatment on menopausal women (Donesta®) on their territories.
  • In parallel, Mithra announces: 8 out of 9 countries selected to host Phase III clinical trials for Mithra’s contraceptive product candidate based on Estetrol (Estelle®) in Europe have already fully approved the clinical trials protocol.
  • The progress of the clinical programs regarding the Estetrol-based products candidate (Donesta®and Estelle®) are in line with objectives and remains on Mithra’s schedule.

Liège, Belgium 29 April 2016 – On the 5 countries selected to host Phase II clinical trial for Mithra’s HRT (Hormone Treatment Therapy) candidate based on Estetrol (Donesta®) in Europe, 3 already fully approved the clinical trial protocol.

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Already 4 European Countries Fully Approved Protocol of MIT-ES001-C301 Estelle Phase III Clinical Study

  • Czech Republic, Sweden, Poland and Norway authorities give green light to start the Phase III clinical studies on their territories.
  • The progress of the clinical program regarding the Estetrol-based contraceptive product candidate is in line with objectives and remains on schedule.
  • In parallel, the MIT-ES001-C302 study will be conducted in the United States and in Canada.
  • Mithra set up an International European Advisory Board about the development of its Estetrol-based contraceptive product candidate to meet market needs.

Liège, Belgium 24 March 2016 – On the 9 countries selected to host Phase III clinical trials for Mithra’s contraceptive product candidate based on Estetrol (Estelle®) in Europe, 4 already fully approved the clinical trials protocol. Competent Authorities and Central Ethic Committees of Czech Republic, Sweden, Poland and Norway gave their green light to start the final study of one of Mithra’s lead R&D projects on their territory.

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Mithra Pharmaceuticals Announces the Appointment of an Estetrol Development Programs Director

Liège, Belgium 16 February 2016 –  Mithra Pharmaceuticals announced today the appointment of a high level R&D profile, Bernard Cornet, to the newly created position of Estetrol Development Programs Director, effective on 15 February 2016. This appointment fits into the reinforcing and structuring program regarding the R&D team for Mithra’s future.

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