Mithra Strengthens Position in the Belgian Contraception Market

  • Mithra builds on leading position in Belgian contraceptive market
  • Mithra achieves significant increase in 2016 sales
  • Market trend validates Mithra’s Estetrol-based programs

Liège, Belgium January 31, 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it increased its market share in Belgium by 0.97% to 45.84% compared to 2015, placing it ahead of Bayer and Merck. The Company also achieved an increase in sales of 4.23%.

Mithra Plans to Submit Myring for US and EU Approval in Q2 2017

Planned submissions follow successful trials demonstrating bioequivalence to NuvaRing®

Liège, Belgium, 24 January 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it intends to submit its combined hormonal contraceptive vaginal ring, Myring, for marketing approval in both Europe and the United States in Q2 2017.

Mithra Announces US Patent Allowance for the Use of Estetrol as Emergency Contraceptive

Liège, Belgium, 18 January 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 14/238,310 a patent which covers the use of Estetrol (E4) as an emergency contraceptive.

Mithra’s North American Advisory Board for Donesta® Will Meet in Miami, Florida 20th- 21st January 2017

  • Mithra has set up scientific advisory boards composed of international experts to support the development of Donesta®, its product candidate for menopause based on Estetrol (E4).
  • The North American scientific advisory board, set up by Mithra, is aiming at gathering additional development guidance from international experts in the menopause field.

Mithra Announces 2017 Financial Calendar

Liège, Belgium 11 January 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces its financial calendar for 2017.

  • 2 March 2017: Full Year Results 2016
  • 18 April 2017: Annual Report 2016
  • 18 May 2017: Annual General Meeting 2017
  • 12 September 2017: Half Year Results 2017

This schedule is indicative and subject to change.

The calendar is also available on Mithra’s Investor website: investors.mithra.com.

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®.

Read the press release

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.

Read the press release