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 Reports Full Year 2020 Financial Results

  • Strengthening of the financial resources and balance sheet structure via various funding transactions for an amount of EUR 260 million, diversifying the sources of financing
  • Record cash position of EUR 138.7 million allowing the continuation of our Business Development strategy for Donesta® and R&D projects beyond Women’s Health, notably in Covid-19 treatment
  • Licensing milestones from backlog contracts signed for Estelle® amount to more than EUR 450 million, with more than EUR 300 million cash to still be collected
  • First marketing authorization (MA) obtained for lead asset Estelle® in Canada, with other MA expected in Europe and the United States in the first half of 2021

 Liege, Belgium, 09 March 2021 – 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 2020, prepared in accordance with IFRS.

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.

Mithra to Host Webcast for 2020 Financial Results on 9 March 2021

Liege, Belgium, 04 March 2021 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health announces that it will host a live webcast on Tuesday, 9 March 2021 at 09:30 CET to present its 2020 financial and operating results.

The live webcast can be accessed on the Mithra website or by clicking here.

To participate to the conference call, please register on this link,

A replay of the webcast will be available on the Mithra investor’s website shortly after the close of the call.

Mithra and Farmitalia Announce Commercial Launch of Myring™ in Italy, the Fourth Largest Market in the World

  • Successful launch of Mithra’s hormonal contraceptive ring in Italy under the trademark Kirkos®
  • Italy is the third largest European market and the fourth worldwide, with 2 million vaginal rings sold per year
  • Mithra CDMO pursues the manufacturing of its Myring™ orders for new commercial launches planned for 2021

Liege, Belgium, 2 March 2021 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of its vaginal contraceptive ring Myring™ in Italy.

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.

 

The Board of Directors appoints Leon Van Rompay as CEO ad interim

Liege, Belgium, 4 February 2021 – 7:30 CET – Meeting this Wednesday evening, the Board of Directors of Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, heard François Fornieri following his indictment in the context of a file relating to functions he previously held in a company not related to Mithra.

 

Nomination of Christophe Maréchal as interim CEO

Liege, Belgium, 21 January 2021 – 22:00 CET – Meeting this Thursday evening, the Board of Directors of Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, took note of the arrest warrant issued against François Fornieri in connection with duties he previously performed in a company not related to Mithra.

Mithra Announces 2021 Financial Calendar

Liege, Belgium, 12 January 2021 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces its financial calendar for 2021 :

  • 9 March 2021 : 2020 Full Year Results
  • 20 April 2021 : 2020 Annual Report
  • 20 May 2021 : Annual General Shareholders Meeting
  • 24 September 2021 : 2021 Interim report

This calendar and all corporate information on the Company (financial statements, events or corporate presentations) is available on the Company’s website in the Investors’ section  (investors.mithra.com).