Mithra Reports 2016 Annual Results

  • Significant operational progress across our transformational E4 (Estetrol) programs and our complex therapeutic solutions positions Mithra for long-term international growth
  • Mithra is accelerating investment and business development activities for its highly promising E4-based pipeline, including the 5th generation oral contraceptive Estelle® and next generation menopause therapy Donesta®
  • Phase III Estelle® oral contraceptive studies initiated in Europe and US

Liège, Belgium, 2 March 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women’s health, today announces its results for the year ended 31 December 2016, prepared in accordance with IFRS.

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®.