Mithra Announces Last Subject Visit in Estelle® Phase III Study in EU/Russia and Completion of Endometrial Substudy

  • Estelle® Phase III studies remain on track to report top-line results in Q3 2018 from Europe/Russia and Q1 2019 from US/Canada
  • Endometrial safety substudy expected to report results in Q3 2018

Liège, Belgium, 3 May 2018 – 7:30 AM – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the last subject in the European/Russian Phase III Estelle® study has now completed her last study visit. Mithra also announces that the endometrial safety substudy has completed recruitment. 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.

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.

Mithra Applies for Additional Estelle® Patent Based on Positive Hemostasis Data

  • Patent will strengthen and extend the existing Estelle® and E4 intellectual property estate
  • Positive hemostasis data differentiate Estelle® from commonly prescribed combined oral contraceptives

Liège, Belgium, 28 March 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has filed an additional patent application in Europe based on the data generated in the Estelle® hemostasis Phase II substudy. 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.

Mithra Announces Completion of Estelle® Cycles Required in Phase III Contraception Studies

  • Estelle® Phase III studies remain on track to report top-line results in Q3 2018 from Europe/Russia and Q1 2019 from US/Canada

Liège, 23 march 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the minimum number of female cycles required by regulators in both of the pivotal Phase III Estelle® studies have now been successfully completed. 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.

Mithra and Mayne Pharma’s Vaginal Contraceptive Ring Accepted for Filing by FDA

  • Filing acceptance is a key regulatory milestone, confirming time line towards potential launch in the US by Mayne Pharma in H1 201
  • Pending FDA approval, Mithra is eligible for down payment and milestone payments totaling at least EUR 10 million
  • Mithra to produce Myring™ for Mayne Pharma at its CDMO, with substantial annual revenues expected

Liège, Belgium, 20 March 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that the Abbreviated New Drug Application (ANDA) for its vaginal ring for contraception has been accepted for filing by the US Food and Drug Administration (FDA). The ANDA has been submitted by Mithra’s partner for the US commercialization of the vaginal ring, Mayne Pharma (ASX: MYX). The acceptance by the FDA is an important regulatory step, as it reconfirms the pathway towards launch of the product candidate in H1 2019.

Mithra and Alvogen Sign LSA for Vaginal Contraception Ring in Russia

  • Mithra grants exclusive license for vaginal contraception ring to Alvogen for commercialization in Russia
  • Agreement follows MyringTM licenses[1] closed with Mayne Pharma, Gynial and Adamed for the US, Austria and the Czech Republic, respectively
  • Vaginal ring shall be manufactured at Mithra CDMO

Liège, Belgium, 16 March 2018, 05:45 PM – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced an exclusive license and supply agreement (LSA) with Alvogen for the commercialization in Russia of Mithra’s contraceptive vaginal ring product candidate made of ethylene vinyl acetate copolymers (EVA). Financial details of the agreement were not disclosed.

Mithra Presents Positive Hemostasis Results at ISGE Conference

  • Analysis across a range of parameters points to limited hemostatic impact for Estelle®, at least comparable to EE/LNG (Melleva®) and much lower than benchmark EE/DRSP (Yaz®)
  • Results corroborate earlier findings and further delineate unique safety profile of Estelle®

Liège, Belgium, March 08, 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today presents more details of its Phase II hemostasis study of Estelle®, Mithra’s combined oral contraceptive (COC) candidate based on 15 mg E4 (Estetrol) and 3 mg DRSP (drospirenone). The data were presented at the occasion of the Gynaecological Endocrinology Conference (ISGE) in Florence.

Mithra Reports 2017 Annual Results

  • Significant operational progress for highly promising E4 (Estetrol)-based pipeline, including 5th generation oral contraceptive Estelle® and next-generation menopause therapy Donesta®
  • Important commercialization partnerships established with leaders in Women’s Health, including Libbs for Estelle® in Brazil, Fuji Pharma for Donesta® in Japan & ASEAN and Mayne Pharma for Myring™ in the US
  • Strong revenue increase and improved EBIT thanks to accelerating business development activity and solid Benelux operations

Liège, Belgium, 2 March 2018 – 7:30 AM : Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on Women’s Health, today announces its results for the year ended 31 December 2017, prepared in accordance with IFRS.