Mithra Announces Positive Donesta® Phase IIb Study Achieving Primary Objective and Confirming Promising Safety Profile

  • E4 Relief dose-finding study identifies 15 mg E4 as the optimal minimum dose for effective treatment of VMS (hot flushes)
  • 15 mg E4 demonstrated a meaningful reduction of over 80% in VMS versus baseline, and a statistically significant reduction compared to placebo
  • Safety profile consistent with previous E4 studies confirming Donesta®’s promising hemostatic and lipid profile, as well as an improved quality of life
  • Data strongly support further development of Donesta® as a unique next-generation hormone therapy

Liège, Belgium, 19 April 2018 – 7:30 AM – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces positive topline results from the E4 Relief Phase II study of Donesta® for the treatment of Vasomotor Symptoms (VMS), and in particular hot flushes relief, in post-menopausal women, with the study achieving its primary and key secondary objectives. Donesta® is Mithra’s next-generation hormone therapy (HT) candidate with oral administration of Estetrol (E4).

Mithra releases 2017 Annual Report and invitation to its Ordinary General Shareholders’ Meeting

Liège, Belgium 16 April 2018 7:30 AM: Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce the publication of its 2017 Annual Report and the invitation to its Ordinary General Shareholders’ meeting.

Annual Report

The Annual Report which outlines Mithra’s achievements in 2017 includes the following information:

  • Overview of Mithra’s R&D pipeline and Letter to Shareholders;
  • Highlights of Mithra’s Strategy and Outlook for 2018;
  • Management Report;
  • Remuneration Report;
  • Financial statements and notes.

François Fornieri, CEO Mithra : “2017 has been a crucial year of progress for Mithra during which we advanced our key clinical programs. These include the pivotal Phase III trials of our innovative 5th generation oral contraceptive, Estelle®, and the Phase II study of Donesta®, our novel candidate for menopausal symptoms. Also, business development activity accelerated significantly, marked by important commercialization contracts, including Libbs for Estelle® in Brazil, Fuji Pharma for Donesta® in Japan and Mayne Pharma for Myring in the US.

We look forward to building on the progress made to date, with important read-outs for both the Donesta® and Estelle® clinical trials during 2018, and the addition of commercial partners for our portfolio in new territories. We are confident that with Donesta® and Estelle®, we have two potential blockbusters in our pipeline that position Mithra for long-term international growth as a transformational leader in Women’s Health.”

Mithra releases its Annual Report in English and French. In case of interpretation differences, the French 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 May 17 2018 at 5:00 PM (CEST) in Liège (Belgium). Mithra is pleased to invite its shareholders.

The notice for the Ordinary General Shareholders’ meeting including a description of the formalities to participate in the Meeting is available on the website investors.mithra.com.

Mithra Signs Principle Agreement for Commercialization of Estelle® in Canada with Women’s Health Specialist Searchlight Pharma

  • Mithra eligible for upfront milestones, recurring revenues and further sales-related payments, for a potential total deal value of at least EUR 50 million
  • With Estelle®, Searchlight aims to further expand its growing footprint in Women’s Health

Liège, Belgium, 12 April 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announced that it has signed a binding Head of Terms agreement with Searchlight, a rapidly-growing Canadian Women’s Health company, for an exclusive license to commercialize Estelle® in Canada. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate currently in pivotal Phase III trials in Europe and Russia as well as in the US and Canada, with top line results expected in Q3 2018 and Q1 2019, respectively.