Richter and Mithra strengthen their partnership and signed a license and supply agreement for the commercialization of Estelle® to Latin America

Budapest, Hungary – Liege, Belgium – 23 December 2020 – 7:30 CET –Gedeon Richter Plc. (‘Richter’) and Estetra S.A, the wholly owned subsidiary of Mithra (Euronext Brussels: MITRA), today announced that they have extended their partnership and signed a license and supply agreement for the commercialization of Estelle®, a novel 15 mg estetrol (E4) / 3 mg drospirenone containing combined oral contraceptive, in order to include key markets in Latin America. The product candidate is considered a novel oral contraceptive with natural, native estrogen acting selectively in tissues combined with additional benefits of drospirenone.

Mithra Announces Positive DSMB Safety Review and Continuation of its Phase III Clinical Program Donesta® in menopause

  • Independent Data Safety Monitoring Board (DSMB) confirms the acceptable safety profile of Donesta® and recommends to continue the Phase III Clinical Program as planned
  • On track to target marketing authorization in 2023
  • Consolidation of business development strategy of Donesta® by successful major funding transactions in 2020

Liege, Belgium, 16 December 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that its independent Data and Safety Monitoring Board (DSMB) completed its end-of-year safety assessment of the Phase III Clinical Program of Donesta®, a next generation orally-administered E4-based hormone therapy product candidate for the relief of menopausal vasomotor symptoms (VMS).

Scientific community convinced of Estetrol’s potential for women’s health

  • At the 19th ISGE Congress, Mithra and Gedeon Richter presented the clinical results of Estelle® to an international scientific audience
  • While Estetrol (E4) has recently been designated as a “New Active Substance” by the European Medicines Agency (EMA), doctors there have confirmed their strong interest in the use of E4 in contraception.

Liege, Belgium, 3 December, 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that physicians at the 19th Congress of the International Society of Gynecologic Endocrinology (ISGE) expressed a strong interest in the clinical results of Estelle®, Mithra’s novel combined oral contraceptive (COC) candidate.

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Mithra’s exclusivity on Estetrol applications extended to 2036 in Europe

Thanks to a new patent relating to Estetrol applications, Mithra secures its future results. A similar process is underway for the US market.

Liège, Belgique, 30 novembre 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has been granted a new patent by the European Patent Office (EPO) relating to various pharmaceutical compositions containing Estetrol (E4) and their manufacturing process. In doing so, Mithra consolidates its exclusivity for the use of E4 in a wide range of indications such as the treatment of hormone-dependent cancers (breast and prostate in particular), dermatology, neuroprotection, dysmenorrhea and emergency contraception

 

Estetrol recognized as a “New Active Substance” by the European Medicines Agency (EMA)

This is the first time in more than 80 years that a new estrogen has been introduced in the field of contraception.

Liège, Belgium, 25 November 2020 – 7:30 CET – Mithra, a company dedicated to Women’s Health (Euronext Brussels: MITRA), today announces that the European Medicines Agency (EMA) has designated Estetrol monohydrate (E4) as a New Active Substance (NAS) in its “Day 180” report, concluding the second phase of the ongoing evaluation of Estelle® birth control pills for the European market.

E4/DRSP, a Novel Combined Oral Contraceptive, submitted to Brazilian regulatory authorities

Liege, Belgium, 17 November 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that the regulatory submission for E4/DRSP, a combined oral contraceptive containing estetrol (E4) and drospirenone (DRSP), has been submitted to the National Sanitary Surveillance Agency (ANVISA) by Mithra’s commercial partner, Libbs, the Women’s Health leader in Brazil.

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.