Mithra inaugure son nouveau centre de développement et de production à Flémalle

  • Mithra annonce aujourd’hui l’inauguration officielle de son CDMO en présence de Jean-Claude Marcourt, Vice-Président du Gouvernement, Ministre de l’Economie, de l’Industrie, de l’Innovation et du Numérique.
  • L’inauguration du bâtiment porte sur la Phase I du projet, à savoir l’infrastructure destinée à la fabrication de formes de polymères, d’implants et d’injectables stériles.
  • La production des premiers lots techniques du produit candidat Myring, un anneau vaginal contraceptif hormonal, est actuellement en cours.
  • Le CDMO est donc opérationnel 3 mois avant l’échéance initialement prévue. La Phase II du projet, à savoir l’infrastructure destinée à la production de comprimés, est actuellement en cours de construction. Mithra confirme également que les travaux seront finalisés dans le respect du budget prévu.
  • Le Mithra CDMO aura permis de créer 54 emplois au sein de Mithra d’ici fin 2016 et permettra d’engager du personnel supplémentaire au fur et à mesure de l’évolution des projets.

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Mithra Will Propose Christiane Malcorps as new Independent Board Member / Phase III Clinical Study for Estelle® in us Launched With First Randomized Patient

Liège, Belgium, 23rd September 2016 –Today, Mithra announces that Christiane Malcorps will be proposed as a new member of Mithra’s Board of Directors (Mithra SA) during the next Shareholders meeting. She also is appointed as member of the Board of Mithra’s CDMO (Development and production center).

Liège, Belgium 23rd September 2016 – Mithra announces today that the first patient has been randomized in the American Phase III clinical trials for its Estetrol-based product candidate Estelle® (E4/DRSP). The enrollment of this first patient marks the official launch of the Estelle® (E4/DRSP) Phase III clinical trial in United States. With this, the Phase III is fully in line with the timing and objectives announced in the Prospectus.

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The Contraception Journal Publishes a Scientific Paper on the Haemostatic Effects of Estetrol; Results Are Encouraging for the Estelle® Product Candidate

  • Mithra Pharmaceuticals announces today the publication of a scientific paper highlighting the reduced haemostatic effects of the Estetrol (E4)/Drospirenone (DRSP) combination, namely the Estelle® product candidate developed by Mithra, in a comparative study with another combined oral contraceptive.
  • The published results are particularly interesting for the scientific community, as they suggest a low procoagulant effect of the E4/DRSP combination that should be clinically verified for low antithrombotic consequences.
  • The Contraception Journal is an international journal on reproductive health ranked among the best publications in the fields of obstetrics and gynaecology. The Contraception Journal is well-known among worldwide specialists and serves as a reference in the medical sphere.

Liège, Belgium, 8 September 2016 – Mithra Pharmaceuticals announces today the publication of a paper in the peer-reviewed Contraception Journal.

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Mithra Pharmaceuticals Announces its First Half 2016 Financial Results and Operational Progress

Liège, Belgium 1 September 2016, 07h30 – Mithra Pharmaceuticals, a leader in Women’s Health market, today announced its consolidated financial results for the six-month period ending 30 June 2016 prepared in accordance with article 13 of the Royal Decree of 14 November 2007. The full interim financial report (regulated information) is available on our website in the Investors section.

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Mithra Signs its First Major Partnership with the Japanese Leader in Women Health Fuji Pharma to Commercialize Estelle® in Japan and ASEAN

  • Mithra signs its first major partnership agreement for Estelle, in line with its strategy to partner out its lead Estetrol-based products earlier for territories outside of the EU and US
  • Mithra’s partner, Fuji Pharma, the leader in the Japanese contraception and dysmenorrhea market, obtains the rights to commercialize Estelle®, Mithra’s oral contraceptive product candidate based on Estetrol, in Japan and ASEAN, representing a total market of EUR 330 million annual sales.
  • The 20-year partnership agreements, which include exclusive supply by Mithra from its CDMO, generate upfront milestones of up to EUR 26 million, of which EUR 10 million is paid at signature.

Liège, Belgium 31 August 2016 – Mithra Pharmaceuticals, a company dedicated to Women’s Health, is extremely pleased to announce it has signed its first major partnership agreement for Estelle®.

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Marc Coucke Appointed Chairman of Mithra’s Board of Directors

  • Mithra Pharmaceuticals announced today the appointment of Marc Coucke as chairman of the Board of Directors.
  • Other changes also occured in the Board of Directors of Mithra Pharmaceuticals.
  • Koen Hoffman, CEO of Value Square and former CEO of KBC Securities, was appointed independent director and will become chairman of the audit committee of Mithra.
  • Freya Loncin, General Counsel Alychlo, was appointed new non-executive director.
  • Professor Jean-Michel Foidart, co-founder of Mithra and current co-chairman of the Scientific Committee of Mithra Pharmaceuticals, was appointed non-executive director.

Liège, Belgium, 26 August 2016 – During the last board meeting, the Board of Directors of Mithra unanimously appointed Marc Coucke as Chairman.

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Mithra Continues to Confirm its Contraception Market Leader Position in Belgium

  • Mithra realized its best selling month in June 2016
  • Mithra remains leader in contraception on the Belgian market (in terms of cycles)
  • Mithra becomes N°2 in terms of value ahead of Organon (MSD)
  • The trend in the market confirms Mithra’s Estetrol-based developments

Liège, Belgium 26 July 2016 – In terms of cycles, Mithra announces that it recorded a 2.8%[3] market share growth compared to June 2015. This represents a significant growth given the 1%[4] decrease recorded on the Belgian contraception market over the same period.

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Green Light from FDA for the Launch of Estelle®(E4/DRSP) Phase III Study in the United States

  • Mithra obtains FDA’s approbation for its Investigational New Drug for the Phase III clinical trials of Estelle® (E4/DRSP).
  • This green light paves the way for the clinical trial of Mithra’s Estetrol-based product candidate in contraception in the United States and in Canada.

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Canada Approves Clinical Trial Application for Estelle® (E4/DRSP) Phase III Study

Liège, Belgium 20 July 2016 –  Mithra announces today that the Canadian authorities approved its Clinical Trial Application (CTA) for the Phase III study for Estelle® (E4/DRSP), the Estetrol-based product candidate in contraception developed by Mithra. This great news has been received a few weeks after the enrolment of the first patient in the Phase III study in Europe. Mithra should receive a feedback from the American Food and Drug Administration (FDA) in the next few days, as well as ethic committees, representing the last step before the launch of the Phase III study in the United States and in Canada.

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Mithra Obtains a Marketing Authorisation for its Own Product Tibelia® in Spain for Which it has Two Commercial Agreements

Liège, Belgium 5 July 2016 – Mithra Pharmaceuticals announces today that it obtained a new Marketing Authorisation for the commercialization of its product Tibelia® (bioequivalent of Livial® developed by Mithra) in Spain.

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