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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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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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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