Mithra and Gynial Sign Commercialization Agreement For Myring™ in Austria

  • Mithra grants non-exclusive 10-year license for vaginal contraception ring MyringTM to Gynial GmbH for commercialization in Austria
  • Agreement follows US license granted to Mayne Pharma
  • MyringTM to be manufactured at Mithra CDMO

Mithra Pharmaceuticals releases 2016 Annual Report and invitation to its Ordinary General Shareholders’ Meeting

Liège, Belgium 18 April 2017 – Mithra Pharmaceuticals is pleased to announce the publication of its 2016 Annual Report and the invitation for its Ordinary General Shareholders’ meeting.

Annual Report

The Annual Report which outlines Mithra’s achievements in 2016 includes the following information:

  • Overview of Mithra’s R&D pipeline and letter to shareholders;
  • Highlights of Mithra’s strategy and outlook for 2017;
  • Corporate governance section;
  • Financial statements and notes.

François Fornieri, CEO Mithra Pharmaceuticals:  “During 2016 we made substantial progress on the key programs that we believe will deliver Mithra’s long-term international growth as a transformational leader in women’s health. We look forward to building on this progress in the year ahead as we move closer to commercializing Estelle® and to selecting a suitable partner to further develop Donesta®. We also anticipate filing for marketing approval for our vaginal contraceptive, Myring™, in both Europe and the US in 2017.”

Mithra releases its Annual Report in English and French. In case of interpretation differences, the English version will prevail. The report is available in English and French and can be downloaded on the website investors.mithra.com as a PDF file.

Ordinary General Shareholders’ meeting

The Ordinary General Shareholders’ meeting of Mithra Pharmaceuticals will be held on 18th May 2017 at 5:00 PM (CEST) in Liège (Belgium). Mithra Pharmaceuticals is pleased to invite its shareholders. The notice for the Ordinary General Shareholder’s meeting including a description of the formalities to participate in the Meeting is available on the website investors.mithra.com.

 

Mithra Signs a Binding Term Sheet with the Japanese Leader in Women’s Health Fuji Pharma to Commercialize Donesta® in Japan and ASEAN

  • Mithra signs a binding term sheet for Donesta® with Fuji Pharma, in line with its strategy to partner out its lead Estetrol-based products
  • Fuji Pharma, the Women’s Health leader in Japan, obtains the rights to commercialize Donesta®, Mithra’s Hormonal Treatment (HT) product candidate based on Estetrol, in Japan and ASEAN. Fuji Pharma intend to extend the actual market of menopause in Japan which represents EUR 42.6 million, thanks to the potential advantages of Estetrol use in menopause.
  • The 20-year partnership agreement, which includes an exclusive supply agreement by Mithra’s CDMO, should generate single-digit upfront milestones. More details on the deal will be communicated when the full and complete LSA is finalized.
  • Mithra also provides an update on its Phase II program for Donesta®. Following discussions with the regulatory agencies and recommendations of its international scientific committees, Mithra has decided to extend the protocol of its Phase II study, and top line results are now expected in Q1 2018.
  • Mithra will accelerate its business development efforts for Donesta®, and plans to identify global partners its Phase III program, as it now does with Fuji.
  • The term sheet with Fuji underlines the strategy adopted, while also demonstrating the value of the reinforced Phase II study for the further development and commercialization of Donesta®.

Mithra Agrees Exclusive Long-Term License and Supply Agreement with Mayne Pharma to Commercialize Myring in the US

  • Mithra grants its first exclusive license for its vaginal contraception ring, Myring, to Mayne Pharma (ASX: MYX), the second-largest supplier of oral contraceptives in the US market, covering commercialization in the United States
  • As part of the agreement, Mayne Pharma will pay milestones of at least EUR 10.0m following approval by the US FDA
  • Mithra will produce Myring for Mayne Pharma at its Research, Development and Manufacturing facility (Mithra CDMO)

Liège, Belgium 28 February 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce an exclusive long-term license and supply agreement that extends beyond 10 years with Mayne Pharma, a leading specialty pharmaceutical company, for the commercialization in the United States of Myring, Mithra’s combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). Mayne Pharma is the second largest supplier of oral contraceptive products in the US market.

Mithra Granted EUR 1.9 million in Non-Dilutive Funding

  • Non-dilutive funding granted by the Walloon region
  • Funding to support Estetrol (E4) and complex therapeutics solutions research projects

Liège, Belgium, 13 February 2017, 07.30am CET – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces that it has been granted EUR 1.9 million in non-dilutive funding from the Walloon Region. The grant follows a decision by the Vice-President and Minister for Economy, Industry, Innovation and New Technologies, Mr Jean-Claude Marcourt.

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.