Publication of a Transparency Notification Received by Mithra Pharmaceuticals SA/NV

Liège, Belgium 09 January 2017 – Regulated information – In accordance with article 14 of the Law of 2 May 2007 on the disclosure of large shareholdings, Mithra Pharmaceuticals SA/NV publishes the following information:

Mithra Pharmaceuticals SA/NV has received a transparency notification dated 29 December 2016, which states that Bart Versluys (Versluys Invest BVBA, Versluys Bouwgroep BVBA), as a result of the net purchase of shares, now has 3,28% of the voting rights in Mithra Pharmaceuticals SA/NV (total number of voting rights : 31.129.756) and as a consequence, crossed the reporting threshold of 3%.

Appointment of Christophe Maréchal as Chief Financial Officer

Liège, Belgium, 6 January 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces the appointment of Christophe Maréchal as Chief Financial Officer (CFO) with effect from 23 February 2017.

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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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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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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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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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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