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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Mithra Files Patent Applications for its Sublingual Form Based on Estetrol Thereby Extending its IP Position to Sublingual Formulations in Contraception and Menopause Until 2036

  • Mithra files patent applications for its sublingual form based on Estetrol, an alternative formulation which could be used in menopause and contraception, including emergency contraception, offering potential protection for these indications until 2036.
  • Mithra initiates galenic formulation of its sublingual form based on Estetrol with Pharmavize, as well as a collaboration with University College London to optimize the organoleptic characteristics of this formulation.
  • Mithra hopes to obtain grant of its patents on the synthesis of Estetrol in Europ by July 2016.

Liège, Belgium, 28 April 2016 – Mithra Pharmaceuticals announces filing patent applications on sublingual forms based on Estetrol, formulations which could be could be used in menopause and contraception, including emergency contraception. The patents on these formulations could offer a protection period running until 2036.

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Mithra Pharmaceuticals Releases 2015 Annual Report and Invitation To its Ordinary General Shareholder’s Meeting

Liège, Belgium 19 April 2016 – Mithra Pharmaceuticals is pleased to announce the publication of its 2015 Annual Report and the invitation for its Ordinary General Shareholder’s meeting.

Annual Report

The Annual Report which outlines Mithra’s achievements in 2015 includes the following information:

  • Overview of Mithra’s R&D pipeline and letter to shareholders;
  • Highlights of Mithra’s strategy and outlook for 2016;
  • Corporate governance section;
  • Financial statements and notes.

François Fornieri, CEO Mithra Pharmaceuticals: “Our 2015 Annual Report highlights the significant milestones Mithra achieved in 2015, a pivotal year in Mithra’s history. It also underlines the efforts and commitment of our teams to support the evolution of Mithra, and more specifically the R&D pillar development of the company.”

This Annual Report is the first Annual Report released by Mithra since its IPO in June 2015. Mithra releases its Annual Report in English and French. In case of interpretation differences, the English version will prevail.

The report is available in English and French and can be downloaded on the website investors.mithra.com as a PDF file.

Ordinary General Shareholder’s meeting

The Ordinary General Shareholder’s meeting of Mithra Pharmaceuticals will be held on 19th May 2016 at 17:00 PM (CEST) in Liège (Belgium). Mithra Pharmaceuticals is pleased to invite its shareholders.

The notice for the Ordinary General Shareholder’s meeting including a description of the formalities to participate in the Meeting is available on the website investors.mithra.com.

Links

Annual Report 2015

Invitation to the Ordinary General Shareholders’ Meeting

Mithra Obtains Three Marketing Authorisations for its Product Tibelia®, one of Which in the United Kingdom Where it Signed a First License and Supply Agreement

  • Mithra already obtained three Marketing Authorisations for its product Tibelia® in United Kingdom, Norway and Sweden.
  • These MA’s occur just a few weeks after the successful closure of the two decentralized procedures providing a green light in 14 European countries. Still 11 Marketing Authorisations to come in the next few weeks and months.
  • Mithra already signed an exclusive License and Supply Agreement with Mercury in the United Kingdom, the fourth biggest potential of the global tibolone market in terms of volume (nearly 14 million tablets in 2015).
  • Tibelia should be available on the UK market in the next few months.

Liège, Belgium 13 April 2016 – Mithra Pharmaceuticals announces today that it obtained three Markering Authorisations for the commercialisation of its product Tibelia® (a product which is bioequivalent to Livial® and developed in-house) in the territories of United Kingdom, Norway and Sweden. These authorisations occur just a few weeks after the successful closure of the two decentralized procedures providing a green light in 14 European countries. There are thus still 11 Marketing Authorisations to come in the next few weeks and months.

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FDA Feedback on SPA Estelle®: a New Step Closer to the Launch of Estelle® Phase III Pivotal Clinical Studies

  • Mithra received feedback on the SPA (Special Protocol Assessment) of the FDA (Food and Drug Administration) regarding its Estelle® Phase III Protocol.
  • At the clinical protocol level, only minor recommendations and requests for clarification were expressed by the FDA.
  • This feedback is comforting and in line with objectives and remains on Estelle® Phase III schedule.

Liège, Belgium 05 April 2016 After receiving encouraging news from the different European countries regarding the Estelle® Phase III pivotal clinical studies under approval, Mithra Pharmaceuticals announces today that the FDA (Food and Drug Administration) also gave encouraging feedback regarding the Estelle® Phase III pivotal clinical study protocol in the United States. Mithra already has the answers at its disposal and will provide them through the IND (Investigational New Drug) submission as planned in the course of June 2016. At the clinical level, only minor recommendations and requests for clarification were expressed by the FDA.

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Topline Results of Food Effect Study of the Product Candidate Estelle®, the new combined oral contraceptive composed of 15mg of Estetrol (E4) and 3mg of Drospirenone (DRSP)

Liège, Belgium 01 April 2016 –  Mithra announces the results of the Food Effect Study of the product candidate Estelle. The study demonstrated that the concomitant food intake with a single dose of Estelle in women resulted in a decrease for Estetrol and Drospirerone rate of absorption (Cmax) while the extent of exposure (AUC) of both Estetrol and Drospirenone was not impacted. This was the result that Mithra wanted to obtain from the study.

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