Update on Zoreline® Projects Including Last Interim Results for the Pharmacodynamics Study of the 3-­‐Month Implant

  • Last interim results for the pharmacodynamics (PD) study of the 3-­‐month implant form reveal the study has exceeded the limits of 8 non-­‐responsive patients set for the trial.
  • The detailed results of this study, still ongoing, will remain completely blinded. Final results are expected end H1 2016 and the full report in the following few weeks.
  • In parallel, the pharmacokinetics (PK) study, is still in progress. On the basis of PD and PK results, expected end H2, Mithra will review the next steps of Zoreline® 3 month implant development.
  • The pharmacokinetics and pharmacodynamics studies for the 1-­‐month form of Zoreline® which is focused on Women’s Health (endometriosis, fibrosis and breast cancer) are expected to begin in summer 2016.

Liège, Belgium, 31 March 2016 – Regulated Information – The development process of Zoreline® program which started in 2015 is composed of 3 steps.

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Formulation Development of the Product Candidate Myring is Complete, Production of Clinical Batches for the Final Bioequivalence Study can Start

  • Formulation development of Mithra’s vaginal ring product candidate is complete
  • The completion of a such complex process shows Mithra’s deep know-how in long acting complex therapeutical entities .
  • Production of clinical batches for the final bioequivalence study can start
  • The final objective is to transfer the technology to the CDMO in Flemalle

Liège, Belgium 30 March 2016 – Mithra announces the completion of formulation development of its vaginal ring product candidate, Myring. This significant milestone was reached in line with objectives and schedule and paves the way to the next phase of development, the production of clinical batches for the bioequivalence study.

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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’s Tibelia® gets green light for market authorization in 14 European Countries, reinforces its CDMO ​production pipeline and demonstrates its development capabilities

·  After Xena® and Levosert®, Tibelia® becomes the third R&D project in which Mithra has been involved from research phase to approval from regulatory authorities, underlining the strength and expertise of its development and regulatory teams in tackling complex generic developments.

·  This step allows Mithra to enter the worldwide tibolone market, a growing market of 131 Million euro, and means that Tibelia® looks set to provide Mithra with a source of near-term cash flow in terms of license payments and sales revenue

·  Additionally, this approval reinforces the pipeline of products that Mithra can produce in-house at its CDMO in Flémalle. 

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Mithra Unveils its Business Plan to More Than 35 French Journalists in Presence of Roselyne Bachelot, Former France’s Health Minister

Liège, Belgium 9 March 2016 – On the occasion of the International Women’s Day, Mithra Pharmaceuticals announced yesterday the launch of its French affiliate, Mithra Pharmaceuticals SAS, during a press conference in Paris in the presence of Mrs. Roselyne Bachelot, former France’s Health Minister.

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Lancering van de website Gyn&co

Brussel, 7 maart 2016 – Met veel genoegen kondigt Mithra Pharmaceuticals u de lancering van de nieuwe website Gyn&co aan, een pedagogisch instrument dat uitsluitend gewijd is aan de vrouwelijke gezondheid en waarvoor de bijdragen geleverd worden door specialisten.

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