• Donesta® Phase II study remains on track to report top line data late Q1 2018
  • 260 women recruited in total, of which 86 have already completed at least 12 weeks of treatment as part of the Phase II study

Liège, Belgium, 13 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the completion of recruitment in the E4 Relief Phase II study of Donesta®, Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4) for Vasomotor Menopausal Symptoms (VMS) relief. Top-line data, based on 12-weeks of treatment, remain on track to be reported late in the first quarter of 2018.

  • Tibelia® would be the first tibolone-based Hormone Therapy product available in Canada
  • Marketing Authorization (MA) decision in Canada expected as of Q4 2018
  • Mithra’s Canadian partner preparing for potential launch shortly thereafter

Liège, Belgium, 10 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that Health Canada has accepted the Marketing Authorization Application for its complex therapeutic Tibelia®, the company’s tibelone-based product for use in Hormone Therapy (HT).

Read the press release
  • 20-year partnership agreement expected to generate a EUR 20 million upfront milestone, as well as annual recurring revenues for the duration of the contract
  • Deal forms part of Mithra’s strategy to realise the full potential of the pipeline programs through global partnerships with leaders in Women’s Health

Liège, Belgium, 26 September 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce that it has signed a binding Head of Terms agreement with Libbs, the Women’s Health leader in Brazil, for an exclusive license to commercialize Estelle®, Mithra’s novel combined oral contraceptive (COC) product candidate, in Brazil.

Read the press release

Liège, Belgium, 21 September 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in women’s health, today announces its financial results for the six-month period ending 30 June 2017, prepared in accordance with IFRS. The full interim report is available on the website in the Investors section (investors.mithra.com).

Read the press release
Read the half year report
  • Estelle® Phase III studies remain on track to report top line results in Q3 2018 and Q1 2019 in Europe/Russia and the US/Canada respectively

Liège, Belgium, 18 August 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that the first European study subject has successfully completed 13 cycles of Estelle® and the end of study physician visit in the E4 Freedom Phase III study program. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP), and is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada.

Read the press release
  • Study to determine impact of demographic characteristics on the absorption, distribution and excretion of Estelle®
  • PK study is part of the Estelle® Phase III program in the US/Canada, which remains on track to report top line results in Q1 2019

Liège, Belgium, 09 August 2017– Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that it has completed recruitment in the population PK substudy for Estelle®. This trial is part of the Estelle® Phase III E4 Freedom program currently ongoing in Europe/Russia and in the US/Canada, with results expected in Q3 2018 and Q1 2019, respectively. Estelle® is Mithra’s combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).

Read the press release
  • Myring™ regulatory approvals in Europe and the US expected in 2018
  • Regulatory submission follows recent European GMP approval for Myring™ production at Mithra CDMO

Liège, Belgium, 17 July 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has filed Myring™ for marketing approval in Europe. Myring™ is Mithra’s version of Nuvaring™, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). The global market for Nuvaring™ amounts to approximately USD 960 million, with over 75% of sales in the US.

Read the press release
  • Patents granted for Estetrol (E4) synthesis protect manufacturing process until 2032
  • Certificate of grant covers E4’s use alone as an emergency contraceptive

Liège, Belgium, 6 July 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that the Australian Patent Office, IP Australia, has granted patents covering the synthesis process of Estetrol (E4). IP Australia has also accepted a patent application for a patent covering E4 alone as an emergency contraceptive. E4, a naturally ocurring estrogen, is currently being studied in the E4 Freedom Phase III study program in contraception (Estelle®, 15 mg E4/3 mg drospirenone) and in the E4 Relief Phase II trial for menopause (Donesta®, dose-finding study with E4 alone).

Read the press release
  • Fuji Pharma obtains rights to commercialize Donesta®, Mithra’s Hormonal Therapy (HT) product candidate based on Estetrol (E4), in Japan and ASEAN
  • 20-year agreement to generate low double digit million development, regulatory and commercialization milestones plus long-term supply revenues
  • Exclusive License and Supply agreement follows binding term sheet announced in March 2017

Liège, Belgium, 28 June 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has signed an exclusive License and Supply Agreement (LSA) with Fuji Pharma, the leader in Women’s Health in Japan, for the commercialization of Donesta® in Japan and ASEAN territories. Donesta® is Mithra’s next generation Hormone Therapy (HT) candidate for which a dose-finding Phase II study is currently ongoing, with top-line results expected late Q1 2018.

Read the press release

Liège, Belgium, 27 June 2017 [5:45 pm CET] – Regulated information – In accordance with article 15 of the Act of 2 May 2007 on the disclosure of large shareholdings, Mithra Pharmaceuticals SA announces the following information, following the issuance of 3,112,975 new shares on 23 June 2017 in the framework of the private placement announced by press release of 21 June 2017.

Read the press release