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 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 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 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 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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Already 4 European Countries Fully Approved Protocol of MIT-ES001-C301 Estelle Phase III Clinical Study

  • Czech Republic, Sweden, Poland and Norway authorities give green light to start the Phase III clinical studies on their territories.
  • The progress of the clinical program regarding the Estetrol-based contraceptive product candidate is in line with objectives and remains on schedule.
  • In parallel, the MIT-ES001-C302 study will be conducted in the United States and in Canada.
  • Mithra set up an International European Advisory Board about the development of its Estetrol-based contraceptive product candidate to meet market needs.

Liège, Belgium 24 March 2016 – On the 9 countries selected to host Phase III clinical trials for Mithra’s contraceptive product candidate based on Estetrol (Estelle®) in Europe, 4 already fully approved the clinical trials protocol. Competent Authorities and Central Ethic Committees of Czech Republic, Sweden, Poland and Norway gave their green light to start the final study of one of Mithra’s lead R&D projects on their territory.

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