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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Financial Results 2015

Liège, Belgium 3 March 2016 – Regulated information – Mithra Pharmaceuticals announced today its 2015 consolidated annual results.

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