European Authorities Approve Advantageous Modifications to Myring™ labelling

  • Removal of requirement for special temperature storage for vaginal contraceptive ring Myring™
  • Competitive advantage in terms of reduced costs and convenience for distributors, pharmacists and patients
  • Similar labelling to be pursued in the United States
Liege, Belgium, 08 November 2019 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that the European Authorities has approved two noteworthy modifications relating to the change in the shelf-life and storage conditions of its vaginal contraceptive ring Myring.

Notice of Extraordinary Shareholders Meeting on 29th November 2019

Liege, Belgium, 30 October 2019 – 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its intention to hold an Extraordinary General Meeting (“EGM”) on the 29 November 2019 at 2:00 PM in Flémalle 57 rue de l’Expansion (Belgium).

Mithra Signs LSA for Commercialization of Myring™ and Tibelia® in Eastern Europe

  • Mithra grants exclusive license to Aicore Life Sciences for commercialization of Myring™ and Tibelia® in Eastern Europe
  • Production of Myring™ at the Mithra CDMO facility in Belgium
  • Agreement follows licensing deals with major international market leaders for commercialization of Myring™
Liege, Belgium, 24 October 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into two exclusive license and supply agreements with Aicore Life Sciences for the registration and commercialization of two major products in contraception and menopause in Eastern Europe: the hormonal contraceptive ring Myring™ and the tibolone-based product Tibelia® for use in Hormone Therapy (HT).

Mithra Announces Publication of Estelle® Abstracts in Connection with the 13th Annual Meeting of the European Society of Gynecology

Liege, Belgium, 22 October 2019 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the publication of abstracts on Estelle® clinical results presented at the 13th Annual Meeting of the European Society of Gynecology (ESG) held from 16-19 October 2019 in Vienna, Austria.

Presentation of Estelle® Phase III results at the 13th Meeting of the European Society of Gynecology

Liege, Belgium, 16 October 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that its Phase III results for Estelle® will be presented at the 13th Annual Meeting of the European Society of Gynecology (ESG) taking place from 16-19 October 2019 in Vienna, Austria.

Mithra Signs Agreement for Commercialization of Myring™ in China with Abbott

  • Mithra grants an exclusive license for commercialization of vaginal contraceptive ring in China
  • The introduction of a long acting contraceptive method represents a compelling new alternative for women in China

Liege, Belgium, 14 October 2019, 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 commercialization agreement with Abbott for the registration and launch of its hormonal contraceptive ring Myring™ in China.

Mithra Initiates Phase III Clinical Program for Donesta®

  • Recruitment of the first patient marking the launch of “E4 Comfort” Phase III Clinical Program for Donesta® in menopausal women with vasomotor symptoms
  • Phase III program includes two pivotal studies aimed at enrolling a total of 2200 women aged from 40 to 65 years

Liege, Belgium, 9 October 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the launch of the Donesta® Phase III clinical program called “E4 Comfort”, with the recruitment of the first patient for the North American Phase III study with E4 monotherapy. Donesta® is a next generation orally-administered E4-based hormone therapy product candidate for the relief of vasomotor menopausal symptoms (VMS).

Mithra Provides Supplementary Details on Estelle® US Deal with Mayne

Liege, Belgium, 3 October 2019 – 7 :30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today provides supplementary details related to the US deal with Mayne Pharma for Estelle®.

Mithra Sucessfully Renegotiates Earnout Payments

  • Remaining payment obligations to Uteron Pharma reduced by 62% to EUR 250 million
  • otal payment duration reduced by twelve years
  • Substantial reduction of total debt under IFRS
  • Significant cash flow improvement safeguarding the development of Estelle® and Donesta®
  • Option for Mithra to pay EUR 40 million cash tranche in equity

Liege, Belgium, 1 October 2019 – 13:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has reached an agreement in the form of a binding term-sheet with the former owners of Uteron Pharma relating to the remaining payment obligations that Mithra has under the current earnout agreement. Former owners of Uteron Pharma, which housed the asset E4 (synthesis and contraception) before divestment to Mithra, include an important number of shareholders.

Mithra Signs Landmark Contract for Estelle® in the United States with Mayne Pharma

  • Historical agreement with Mayne Pharma, who became the second largest supplier of oral contraceptives in the US after the acquisition of a portfolio of branded generic products from TEVA in 2016
  • Record deal value for Estelle®. Potential gross revenues in Mithra’s worst-case scenario at a minimum of EUR 4,5 billion, which represents more than twice the size of European deal
  • Mithra eligible for license fees of at least USD 295 million
  • Mithra to be awarded 9.6% equity stake across two tranches in Mayne Pharma
  • CDMO cross fertilization opportunities for both companies
Liege, Belgium, 01 October 2019 – 13:00 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is very pleased to announce that it has signed a License and Supply Agreement (LSA) with Mayne Pharma Group Limited (hereinafter referred to as “Mayne”), a leading Women’s Health player in oral contraceptives in the United States (US), for an exclusive license to commercialize Estelle® in the US. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate based on Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile. E4 is a native estrogen produced by the human foetal liver during pregnancy. Following more than 20 years of research and development, Mithra can now produce E4 at scale through a complex plant-based (soja) production synthesis process.