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®.

Read the press release

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.

Read the press release

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.

Read the press release

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.

Read the press release

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.

Read the press release

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.

Read the press release

First Patient Screened for the European Product Candidate Estelle® (E4/DRSP) Phase III Clinical Study: the Phase III Has Started in Europe Ahead of Schedule

Liège, Belgium 30 June 2016 – Mithra announces today that the first patient has been screened for enrolment in the European Phase III clinical trials for its Estetrol-based product candidate Estelle® (E4/DRSP). The screening of this first patient marks the launch of the Estelle® (E4/DRSP) Phase III clinical trial in Europe.

Read the press release

Mithra Pharmaceuticals Hosts its 2016 Investor Day and Reaffirms its Strategy for the Upcoming Years

Brussels, Belgium 29 June 2016 – Mithra Pharmaceuticals hosts its 2016 Investor Day today in Brussels. Through interviews with the CEO François Fornieri, members of the Executive Management and of the Scientific Committee, Mithra provides an update on its strategy and business model, as well as on its Research and Development projects one year after its Initial Public Offering.

Read the press release