Mithra Launches its Product Tibelia on the Global Market

  • Mithra Pharmaceuticals received 14 Marketing Authorizations (MA) in 12 European countries for its product based on tibolone.
  • Mithra should receive shortly 3 more authorizations for France, Italy and Greece.
  • Tibelia received 24 months shelf-life and should be able to extend this one in 36 months in 2017, what would give the product a unique advantage on the market and would make it more competitive than its competitors.
  • In 2016, Mithra signed 8 License and Supply Agreements.
  • Mithra expects to sign other agreements with Ukraine, Russia, Chile, Singapore, France and Switzerland.
  • Mithra estimates, according to the sales forecasts of his distributors, incomes in double digit for the next five years.

Liège, Belgium, 22 December 2016 – Mithra Pharmaceuticals, a company focused on Women’s Health, announces today that it obtained 14 Marketing Authorizations for the commercialization of its product Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is still waiting for 3 MA in France, Greece and Italy that should be received by the beginning of 2017.

The product based on tibolone developed by Mithra will be more competitive due to its extended shelf-life.

Valérie Gordenne, CSO Mithra Pharmaceuticals: “At this stage, we believe we can justify a shelf-life of 36 months versus 24 months for the competitors. Currently, data are available on 24 months for the pilot batches. Trends show a possible stability extension. The results are confirmed on the first industrial batch (18 months). The best stability of the active ingredient in the formulation is linked to specific components of this formulation, for which a patent has been applied.”

In 2016, Mithra signed 8 License and Supply Agreements in the United Kingdom, Spain, Switzerland, Germany, Benelux, Australia, South Africa, Canada and Finland for a total amount in double digit, down payments included. In 2017, Mithra expects to sign other agreements with Ukraine, Russia, Chile, Singapore and France.

In United Kingdom, marketing is already effective, as well as it will be effective in Spain and Holland in January 2017.

François Fornieri CEO Mithra Pharmaceuticals: “Obtaining a Marketing Authorization for a product candidate is a real recognition of the unique expertise of our team in terms of development and regulatory affairs. Tibelia is set to be a competitor on the European market. It is indeed a ‘complex’ therapeutical solution as tibolone, the active ingredient involved, is known as a particularly unstable active ingredient, presenting many challenges in terms of development. Obtaining marketing authorisations for such a product is a significant validation for Mithra’s development and regulatory expertise, which was previously demonstrated in the development of Mithra’s first R&D projects developed in the past, and which will continue to serve it well as it continues to develop and prepare the regulatory pathway for its lead products based on Estetrol.”

The global market of tibolone is an attractive and growing market of EUR 131 million , accounting for an increase of 4.3% in value . In terms of volume, this market represents 315 million tablets, up 2% .

About Tibelia

Tibelia is a synthetic steroid (tibolone) intended to be used for hormone replacement therapy. Tibelia is a product that mimics the activity of the female sex hormones in the body, and is used especially for the relief of symptoms occurring after menopause. In some countries, this product is also used for the prevention of osteoporosis. It has been demonstrated that tibolone has favourable effects on various tissues in the body, such as brain, vagina and bone .

 

Success for Myring European Clinical Trial

  • Myring demonstrates bioequivalence to European version of NuvaRing®
  • Mithra preparing to file for regulatory approval in Europe and the U.S. in Q2 2017

Liège, Belgium, 8 December 2016 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces the results of the first of two bioequivalence studies, which demonstrate that its combined hormonal contraceptive vaginal ring, Myring, is bioequivalent to the branded European version of NuvaRing®.

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Mithra Signs a LOI for the Chinese Rights on Estetrol in Women’s Health with the Market Leader in Women’s Health in China, Zhejiang XianJu Pharmaceutical

  • Letter of Intent between Mithra and Xianju, market leader in China, for Estetrol-based products in Women’s Health; multiple indications to be determined in common agreement
  • Chinese clinical trials to be conducted and financed by Xianju

Liège, Belgium 16 November 2016 – Mithra Pharmaceuticals is pleased to announce it has signed a Letter of Intent with Zhejiang Xianju Pharmaceutical to work towards a broad partnership on Estetrol in Women’s Health, in multiple indications to be determined in common agreement. Both parties intend to finalize their partnership in an agreement before the end of February 2017.

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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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