Mayne Pharma and Mithra Announce FDA Approval of New Oral Contraceptive Estelle®

15 April 2021, 22:30 CEST, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel combined oral contraceptive Estelle® under the trademark Nextstellis® (15 mg Estetrol (E4) / 3 mg drospirenone (DRSP)). Mayne Pharma anticipates the commercial launch of Estelle® by the end of June 2021.

Richter and Mithra Receive Positive CHMP Opinion for Estelle®

Budapest, Hungary – Liege, Belgium – 26 March 2021 – 13:15 CET – Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a novel combined oral contraceptive containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). Subject to approval by the European Commission, the marketing authorization valid for all European Union Member States is expected to be granted by the end of the second quarter 2021. The product will be marketed in Europe by Richter under the brand name Drovelis®.

Richter is dedicated to bring to market innovative treatment like Drovelis® that will widen the selection of products within the female contraception solutions”, said Erik Bogsch, Executive Chairman of Gedeon Richter Plc. “We are encouraged by this positive opinion from the CHMP and we shall do our best to make Drovelis® available to physicians and patients in Europe.”

After Estelle® first approval granted in Canada early this month, we are very pleased with this positive opinion given by the European Medicines Agency”, said Leon Van Rompay, CEO of Mithra. “Being able to offer the result of so many years of work to women is a huge achievement for a biotech such as Mithra. It demonstrates the resilience of our teams which, despite of the turbulences caused by Covid-19, managed to take up the challenge with flying colors. We are pleased to collaborate on this exciting project with our long-standing partner Gedeon Richter as this further strengthens our successful partnership.”

Prof Jean-Michel Foidart, Permanent Secretary of the Royal Academy of Medicine of Belgium, added: “We’ve been working on Estetrol, a native hormone produced by the human body during pregnancy, for more than ten years to develop a new generation contraceptive pill with a clear benefit/risk aiming to improve women’s quality of life. This product promises to be a major breakthrough in a space where there hasn’t been any innovation in decades.”

“This new product has an unique profile, significantly supports reproductive health preservation and conscious family planning. Estetrol combined with drospirenone represents a major innovation breakthrough in reproductive health and sets a new horizon for women around the world,” stated Professor Emeritus György Bártfai, the Chairman of the Egon and Ann Diczfalusy Foundation, founded in 2007 to preserve and forward professor’s spirit and legacy for the next generations.


Mithra and Searchlight Pharma Announce Estelle® Approval in Canada

First E4-based product approved internationally

  • Canadian regulatory approval is the first in the world for the novel combined oral contraceptive Estelle®
  • Innovative product developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP)
  • Approval supported by two large multinational Phase 3 studies conducted in 3,725 women
  • Commercial launch in Canada anticipated mid-summer 2021

LIEGE (Belgium – 7:30AM CET) and MONTREAL (Canada – 7:00AM EST), March 8, 2021 – Mithra and Searchlight Pharma announce today that Health Canada has approved Estelle® under the trademark Nextstellis®, the first and only combined oral contraceptive (COC) product based on the unique native estrogen Estetrol (E4). Once launched, E4 will be the first new estrogen in a COC in the Canadian market in over half a century, and will be the only COC alternative to ethinyl estradiol-based COC pills in Canada.

Estelle® Study Results Published in Leading Peer-Reviewed Medical Journal

• Publication of an article on Estelle® endocrine and metabolic parameters in prestigious Contraception Journal
• Article concludes on limited impact of Estelle® compared to Ethinylestradiol-based combined oral contraceptives
• Estelle® filing on going in the U.S., Europe and Canada, with expected marketing authorization in H12021

Liege, Belgium, 9 February 2021– 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the publication of a scientific paper entitled “Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone” in Contraception Journal, one of the most prestigious peer-reviewed journals in the field. A link to this publication can be accessed here.


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.

Read the press release

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.