Mithra Announces Positive Results of Ovarian Function Sub-Study which Strengthens Estelle® Contraceptive Efficacy Profile

  • Effective ovulation inhibition with no single ovulation at cycles 1 and 3
  • Data further strengthens the contraceptive efficacy profile of Estelle® previously shown in top-line EU/Russia phase III study results
  • Results further support Estelle® as a novel, next-generation combined oral contraceptive for women

Liège, Belgium, 6 December 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced positive results from its ovarian function sub-study for Estelle®, Mithra’s combined oral contraceptive (COC) candidate composed of 15mg Estetrol (E4) and 3mg drospirenone (DRSP). The study forms part of the broader development plan to demonstrate the overall contraceptive efficacy of Estelle®.

 

 

Mithra Reduces Environmental Impact of CDMO facility in Belgium with the Installation of 1800 Solar Panels

Liège, Belgium, 21 November 2018 –  Mithra (Euronext Brussels: MITRA) announces that it has reduced the environmental impact of its CDMO facility in Belgium with the installation of 1800 solar panels. Mithra has also put in place an internal committee within its CDMO with the aim of reducing costs and minimizing the environmental impact of the company’s manufacturing activities.

Mithra Signs Exclusive License and Supply Agreement for Vaginal Contraceptive Ring in Australia and New Zealand

  • Mithra grants exclusive 10-year license for commercialization of vaginal contraception ring in Australia and New Zealand to Neo Health
  • Product to be manufactured at Mithra CDMO facility in Belgium
  • Agreement follows licensing deals for Myring™ with market leaders in the US, Austria, Czech Republic, Chile, Denmark, Russia
Liège, Belgium, 20 November 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that it has entered into an exclusive 10-year license and supply agreement with Neo Health (OTC) Pty Ltd (Neo Health) for the commercialization of its combined hormonal contraceptive vaginal ring in Australia and New Zealand. The vaginal ring, made of ethylene vinyl acetate copolymers (EVA), is known as Myring™ in other markets but will be marketed under a different brand name in Australia and New Zealand.

Full Estetrol (E4) Program Update Provided at Scientific Advisory Board Meetings

  • Scientific Advisory Boards consulted for the next stages of development and regulatory approval of Estelle® and Donesta® – Mithra’s late stage contraceptive and menopause candidates
Liège, Belgium, 19 November 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces that it held two scientific advisory board (SAB) meetings in New Orleans (LA) at the end of October to discuss the progress in the development plans for Estelle® and Donesta®, Mithra’s key programs for contraception and menopause. The SABs, composed of American and Canadian experts in these fields, provided constructive feedback on the recently completed EU/Russia phase III trials for Estelle®. Guidance on the phase III clinical development plan for Donesta®, Mithra’s next generation hormonal therapy, was also received.

Mithra Announces the Completion of its Lead Clinical Phase III Programme for Estelle®

  • Completion of Estelle® Phase III US/Canada study of Estelle® phase III programme completes
    Mithra’s most advanced clinical programme
  • EU/Russia study reported positive results achieving primary and secondary endpoints
  • Estelle® Phase III study in US/Canada will report top-line results in Q1 2019
  • Estelle® : a step closer to become next generation COC on the market

Liège, Belgium, 14 November 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of the Phase III Estelle® study in the US and Canada. Estelle® is Mithra’s novel combined oral contraceptive (COC), containing 15 mg Estetrol (E4)/3 mg drospirenone (DRSP). Top line data remain on track to be reported in Q1 2019.

New Warrant Plan Approved by Mithra Shareholders

Liège, Belgium, 06 November 2018 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that shareholders have approved the issuance of a maximum of 1,881,974 warrants under a new warrant plan (‘Warrant Plan’), for the benefit of key employees, members of the management team and certain directors. The Warrant Plan was approved at the Company’s Extraordinary General Meeting (EGM) held on 5 November 2018.

Mithra Signs Exclusive License and Supply Agreement with Adcock Ingram for Commercialization of Estelle® in Southern Africa

  • Mithra is eligible for a downpayment of EUR 1.5 million
  • 20-year exclusive license and supply agreement to generate annual recurring revenues and royalty payments
  • Production at the Mithra CDMO facility
  • Deal forms part of Mithra’s strategy to realise the full potential of the pipeline programs through global partnerships with leaders in Women’s Health

Liège, Belgium, 30 October 2018 – Mithra (Euronext Brussels: MITRA) today announced that it has entered into an exclusive license and supply agreement with Adcock Ingram to commercialize Estelle®, a combined oral contraceptive (COC), containing 15 mg Estetrol (E4) / 3 mg drospirenone (DRSP), in Southern Africa1. The product is a novel combined oral contraceptive with natural, native estrogen acting selectively in tissues combined with DRSP’s non-contraceptive benefits.

2018 Update and 2019 Outlook Given at the CPHI Conference

  • Estelle® Oral Contraception programme on track – US/CANADA Phase III arm due to complete in Q4 2018; partnering discussions ongoing including for us market
  • Preparations for Phase III Donesta® trials moving ahead, including co-partnering discussions
  • Further Marketing authorisations obtained for MyRing™

Liège, Belgium, 10 October 2018 – 20:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, provided an update on its key programmes at the CPHI world conference.

Notice of 2018 Extraordinary General Meeting Regarding Proposed Warrant Plan

Liège, Belgium, 5 October 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces its intention to hold an Extraordinary General Meeting (“EGM”) on the 5 November 2018 at 11:00 am in Flémalle, 57 rue de l’Expansion (Belgium). The meeting will consider a new warrant plan whereby a maximum of 1,881,974 warrants would be issued, subject to shareholder approval.

 

Presentation of Donesta® PhIIb Results at the 2018 Annual Meeting of the North American Menopause Society

Liège, Belgium, October 3nd 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces its Phase IIb results for Donesta® will be presented at the 29th Annual Meeting of the North American Menopause Society (NAMS), being held on 3-6 October 2018 in San Diego, CA.