Mithra Signs LSA for Commercialization of Estelle® in North Africa

  • Mithra grants exclusive license to GyneBio Pharma for commercialization of its combined oral contraceptive Estelle® in Algeria, Morocco and Tunisia
  • Deal worth up to EUR 25 million for Mithra over the contract period
  • Agreement follows licensing deals for Estelle® with market leaders in key regions such as U.S., Europe, Australia, South America, ASEAN and Middle East

Liege, Belgium, 19 October 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into an exclusive license and supply agreement with Gynebio Pharma for the commercialization of Estelle® in North Africa. Estelle® is a novel, next generation oral contraceptive product candidate containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile.

Mithra Announces FDA update

  • Mithra’s US partner Mayne Pharma receives complete response letter from FDA for Myring™ requesting additional data that is not normally requested for generic products
  • Based on the information available to date, Mithra expects to have the necessary data in hand to respond to FDA before year-end
  • No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process
  • Mid-cycle review with FDA regarding the New Drug Application (NDA) for Estelle (Nextstellis) raised no substantive issues
  • Solid cash position and funding facilities to cover working capital needs

Liege, Belgium, 6 October 2020 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX: MYX)  has received a Complete Response Letter from the US Food & Drug Administration (FDA) related to the abbreviated new drug application (ANDA) for Myring™, the vaginal ring made of ethylene vinyl acetate copolymers (EVA).

Mithra Announces FDA Filing Acceptance of New Drug Application for Estelle® in the US

Liege, Belgium, 24 June 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the New Drug Application (NDA) for Estelle® has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.

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.

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 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 Receives acceptance of Marketing Authorization Application (MAA) to market Estelle® in Belgium and Luxembourg

Liege, Belgium, 03 March 2020 – 7:30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the European Medicines Agency (EMA) has accepted its regulatory submission to market Estelle® in Belgium and Luxembourg.  Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate, containing 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).

EMA Accepts Richter’s Marketing Authorization Application (MAA) for Estelle®, a Novel Combined Oral Contraceptive

Liege, Belgium, 27 February 2020 – 17:45  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that the European Medicines Agency (EMA) has accepted Gedeon Richter’s (hereinafter: “Richter”) regulatory submission for Estelle®, a combined oral contraceptive containing estetrol (E4) and drospirenone.

Developed by Mithra, the product candidate is composed of 15 mg estetrol (E4), a unique native estrogen and 3 mg drospirenone. E4 is produced by the human fetus, passing the maternal blood at relatively high levels during pregnancy. In two phase III clinical studies conducted in 3,725 women, E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.

According to the relevant license agreement, Richter will commercialize the product in Europe, Russia and other CIS countries.

Graham Dixon, Chief Scientific Officer of Mithra Women’s Health, commented: The submission to the EMA marks a significant step toward commercialization of Estelle® in Europe. With this submission we are on-track for potential market authorization in H1 2021.  Estelle® promises to provide women with a new choice in oral contraception, combining efficacy with a much improved safety profile. In a space where there hasn’t been any innovation in decades, this will be a major breakthrough.