Mithra Signs License and Supply Agreement with Mayne Pharma for Commercialization of Estelle in Australia

  • Consolidation of partnership with Mayne Pharma for commercialization of the combined oral contraceptive E4/DRSP (Estelle®) in Australia
  • Mithra eligible for milestone and license fees of up to EUR 3.5 million
  • Preparation ongoing for the commercial launch of Mithra’s oral contraceptive in the U.S. and Australia, targeted for H1 and H2 2021 respectively

Liege, Belgium, 28 May 2020 – 8:15 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces it has entered into an exclusive 20-year license and supply agreement with Mayne Pharma Group Limited (“Mayne”) for the commercialization of its combined oral contraceptive E4/DRSP (Estelle) in Australia.

Mithra Launches a Research Programme on Estetrol’s Effect in Covid-19 Treatment

  • Women are more likely than men to be spared by Covid-19, with less severe infections and lower mortality rates
  • Protective role of estrogen against human coronaviruses already demonstrated during the SARS infection, and currently being tested in the U.S. among hospitalized patients
  • Mithra plans to develop a research program to study Estetrol (E4) mechanism of action in the treatment of Covid-19.

Liège, Belgium, 25 May 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its intention to launch a Phase II study program to assess the potential beneficial effect of Estetrol (E4) on Covid-19 infection. E4 is a naturally occurring estrogen produced by the liver of the human fetus, passing in maternal blood at relatively high levels during pregnancy.

Mithra and Searchlight Pharma Announce Filing of New Drug Submission for Estelle® in Canada

  • Searchlight Pharma’s New Drug Submission for a novel combined oral contraceptive (COC) accepted for review by Health Canada
  • Innovative product candidate developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP)
  • Potential commercialization in Canada under the trademark Nextstellis® expected in mid 2021

LIEGE (Belgium) and MONTREAL (Canada), 20 May 2020 – 7:30 CEST – Mithra and Searchlight Pharma announced today that Health Canada has accepted Searchlight Pharma’s New Drug Submission (“NDS”) for a novel combined oral contraceptive (COC) product.

Mithra and Gynial Sign Commercialization Agreement for Myring™ in Switzerland

  • Mithra grants license for its vaginal contraceptive ring to Gynial for commercialization in Switzerland
  • Strengthening its partnership with Women’s Health specialist Gynial, already responsible for the Austrian market
  • Large-scaled global commercialization of Myring™ after first successful launches in Europe

Liege, Belgium, 05 May 2020 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into a license and supply agreement (LSA) with Gynial GmbH for the commercialization of its hormonal contraceptive ring Myring™ in Switzerland.

Mithra Obtains a Capital Commitment Agreement of EUR 50 Million from Partner LDA Capital

Liege, Belgium, 24 April 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into a capital commitment agreement with LDA Capital Limited, a Los Angeles based global investment group with expertise in cross border transactions in life science sector.

Mithra Releases 2019 Annual Report and Invitation to its Securities holders’ Meeting

Liege, Belgium, 22 April 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the publication of its 2019 Annual Report and the invitation to its Ordinary and Extraordinary General Securities holders.

2019 Annual Report

The Annual Report which outlines Mithra’s achievements in 2019 includes the following information:

  • Overview of Mithra’s R&D pipeline and Letter to Shareholders;
  • Highlights of Mithra’s Strategy and Outlook for 2020;
  • Management Report;
  • Remuneration Report;
  • Financial statements and notes.

The Annual Report is available in English and French and can be read (or downloaded in PDF) on the website investors.mithra.com. In case of interpretation differences, the French version will prevail.

François Fornieri, CEO Mithra Women’s Health, commented:

2019 marked our 20th anniversary and was exceptional in more ways than one. We recorded a strong turnover increase, achieved key milestones in both clinical development and international growth, and a CDMO that successfully moved into commercial production. In 2020, despite this unprecedented situation caused by Covid-19, our teams are determined to do everything possible to meet our ambitious challenges.”

 

 

General Shareholders’ meeting

Mithra is pleased to invite its securities holders to its Ordinary and Extraordinary General Shareholder’s meeting that will be held on Friday May 22 2020 at 2:00 PM (CEST).

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

Exceptional organisational arrangements due to Covid-19 have been made

 

Mayne Pharma Submits New Drug Application For E4/DRSP to the FDA

16 April 2020, Adelaide Australia and Liege, Belgium – Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking marketing authorisation for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy in women. If approved by the FDA, E4/DRSP is expected to be made available to patients in the US market in the first half of calendar 2021.

Mithra Announces Commercial Launch of Myring™ in Germany, the biggest market in Europe

  • Successful launch of Mithra’s hormonal contraceptive ring in Germany under the trademark MYCIRQ®
  • Germany is the largest European market and the second worldwide, with 3 million vaginal rings sold per year
  • Mithra CDMO pursues the manufacturing of its Myring™ orders in compliance with all the measures required by the Belgian authorities

Liege, Belgium, 2 April 2020 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the commercial launch of Myring™ in Germany, which is the largest European market and the second worldwide in terms of sales volume. With 3 million vaginal rings sold per year, the German contraceptive rings market is worth EUR 27 million per year.

 

Mithra Announces Donesta® Phase III Clinical Program Update

Liege, Belgium, 01 April 2020 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces an update on the Donesta® Phase III Clinical Program called “E4 Comfort”, which aims at enrolling approximately 2200 menopausal women (40-65 years) and includes two pivotal studies: in North America (United States/Canada) launched in October 2019, and in Europe, Russia and South America launched in December 2019. For each pivotal study, women will be recruited in about 120 sites in the concerned areas.

Mithra Reports Full Year 2019 Financial Results

  • Record revenue (EUR 96.5 million) and EBITDA (EUR 40.7 million) increased respectively by 47% and 6%, mainly driven by U.S. deal for Estelle®
  • Anticipated future licensing milestones for Estelle® of EUR 322 million (out of a total of EUR 486 million)
  • Net loss significantly reduced to EUR 26.6 million (EUR 89.7 million in June 2019) thanks to successful earnout renegotiation and landmark deal with Mayne Pharma for Estelle®
  • Strengthening of book equity to EUR 163.3 million thanks to earnout renegotiation
  • Continued good cash management with comfortable level of cash at year-end
  • Key milestones achieved for environmental-friendly E4-based portfolio pipeline, with successful launch of Phase III study of Donesta® in menopause and regulatory submission of Estelle® in Europe
  • Valuation of business entity for clinical development projects based on E4 in 2020


Liege, Belgium, 09 March 2020 – 7:30  CET
– Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the year ended 31 December 2019, prepared in accordance with IFRS.