Liège, Belgium 10 May 2016 –  Mithra announces that the production of the first technical and clinical batches of Myring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), has started within its external CMO (Macors). These clinical batches will be used in the bioequivalence study.

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  • Mithra Pharmaceuticals announces today the publication of a scientific article based on the results of the E4 FIESTA Phase II study of its estetrol-based product candidate Estelle®, a combined oral contraceptive composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP).
  • The article describes the bleeding pattern and cycle control observed with different E4 combinations.
  • The published results are very interesting for the scientific community as they demonstrate the good bleeding profile of the Estetrol-based product candidate Estelle®, which will be confirmed in the coming phase 3 studies.

Liège, Belgium, 4 May 2016 – Mithra Pharmaceuticals announces today that an article has been published in the peer-reviewed Contraception Journal. The published results of the E4 FIESTA Phase II study are particularly encouraging for the imminent launch of the Phase III studies.

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  • 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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  • 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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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

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

Download the press releaseDownload the Financial Results 2015

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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Liège, Belgium, 5th February 2016 – Mithra Pharmaceuticals announced today that the 9th Annual PLG Business Development Awards saw François Fornieri from Mithra Pharmaceuticals win the AstraZeneca Business Development Executive of the Year 2015 for leading 3 transformational deals throughout 2015, making Mithra a leading challenger in Women’s Health.

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