Mithra Signs Exclusive License and Supply Agreement with Fuji Pharma for Donesta® in Japan and Asean

  • 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.

Information on the total number of voting rights (denominator)

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.

Estelle® Phase IIB Results on Well-Being and Body Weight Published in Leading Peer-Reviewed journal

  • European Journal Of Contraception and Reproductive Health Care publishes article on Phase IIb results of Estelle®, Mithra’s combined oral contraceptive candidate
  • Article reports on Estelle’s® high acceptability, user satisfaction and general well-being in addition to favorable body weight control
  • Estelle® is currently being tested in two large-scale Phase III studies, with top-line results expected in Q3 2018-Q1 2019

Liège, Belgium, 26 June 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that the European Journal of Contraception and Reproductive Health Care, one of the most prestigious peer-reviewed journals in the field, has published an article[1] detailing the acceptability, user satisfaction, well-being and body weight control of Estelle® in the Phase IIb FIESTA study. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada, the results of which should be available in Q3 2018 and Q1 2019, respectively.

[1] Article available online at http://www.tandfonline.com/doi/full/10.1080/13625187.2017.1336532

Mithra Successfully Raises €26.1 Million

Liège, Belgium, 21 June 2017, 02:50pm CET – Mithra Pharmaceuticals SA (the ‘Company’ or ‘Mithra’), a company specialized in Women’s Health (Euronext Brussels: MITRA), announces that it has successfully raised €26.1 million in gross proceeds by means of a private placement of new shares via an accelerated bookbuild offering (the “Private Placement”).

Mithra Launches a Capital Increase by Means of a Private Placement via an Accelerated Bookbuild Offering

Liège, Belgium, 21 June 2017 [8.00am CET] – Mithra Pharmaceuticals SA (the ‘Company’ or ‘Mithra’), a company specialized in Women’s Health (Euronext Brussels: MITRA), announces the launch of a capital increase of up to 3,112,975 shares (representing just below 10% of the Company’s shares currently admitted to trading on Euronext Brussels) by means of a private placement via an accelerated bookbuild offering (the ‘Private Placement’).

Mithra Completes Recruitment for Additional Estelle® Safety Study

  • Safety study is part of the development of Estelle®, Mithra’s combined oral contraceptive candidate
  • Aim of the study is to analyze a broad range of safety parameters for Estelle®, including hemostatic, endocrine and metabolic markers

Liège, Belgium, 21 June 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has completed recruitment into a safety study to evaluate the effect of Estelle® on endocrine function (thyroid, adrenal), metabolic control (lipid and carbohydrate metabolism) as well as on a broad panel of hemostasic markers. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently being tested in two Phase III trials in Europe/Russia and in the US/Canada, the results of which are expected in Q3 2018 and Q1 2019, respectively.

Mithra Receives Orphan Drug Designation from EMA for E4 in Neonatal Encephalopathy

  • Orphan Drug Designation received from European Medicines Agency for Estetrol (E4) in the treatment of life-threatening Neonatal Encephalopathy
  • Evidence of potential of E4 to address additional indications beyond Women’s Health
  • Preclinical results form basis for potential additional partnerships for E4
Liège, Belgium 9 June 2017 –  Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has received Orphan Drug Designation (ODD) for E4 in Neonatal Encephalopathy (NE). Mithra intends to develop E4 to treat Hypoxic Ischemic Encephalopathy (HIE), a subset of NE which accounts for 50-80% of cases and affects pre-term and new born babies (>36 weeks gestation).

Mithra Signs Exclusive Agreement for Tibelia® in Canada

  • Tibelia® would be the first tibolone-based Hormone Therapy product available in Canada
  • Marketing authorization process is ongoing
  • Tibelia® already marketed in a number of countries through supply and license agreements

Liège, Belgium, 6 June 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has signed an exclusive License and Supply Agreement for Tibelia®, its generic version of tibolone for use in Hormone Therapy (HT), with an undisclosed Canadian partner. Tibelia® is a generic version of Livial®.