Mithra Wins BelMid Company of the Year 2018

Liège, Belgium, 18 January 2019 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, has been awarded BelMid Company of the Year 2018 by Euronext Brussels at its annual New Year’s Ceremony held in Brussels last night.

Blockbuster Potential in Perimenopause with new E4 Candidate and Acceleration of Donesta Phase III Program

  • Potential for new perimenopause product candidate PeriNesta launch as early as 2023, with an estimated market opportunity of at least 18 million patients annually in the US and key EU markets
  • Donesta® phase III E4 monotherapy patient recruitment anticipated to start in Q3 2019 pending approvals , potential market authorisation by end 2023
  • Ongoing global patent filings could protect Donesta® and PeriNesta IP estate until 2039

Liège, Belgium, 07 January 2019 – 6:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the further expansion of its Estetrol (E4)-based programs with a decision to target the underserved perimenopausal market, which affects women between reproductive age and post-menopausal age. The Company believes this additional indication for a product with a comparable formulation to E4 15mg/DRSP 3mg represents a major new market opportunity that requires only limited additional investment.

The Company also announced plans to accelerate preparations for its proposed Phase III E4 monotherapy study of Donesta® in menopause. Mithra has appointed leading specialist Contract Research Organization (CRO) ICON Plc (NASDAQ: ILCR) to manage the study and recruitment is expected to begin in the second half of 2019, pending approvals.

Mithra Announces Attendance at the 37th Annual J.P. Morgan Healthcare Conference

Liège, Belgium, 04 January 2019 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that Chief Executive Officer Mr. François Fornieri and members of the executive management team will be attending the 37th Annual J.P. Morgan Healthcare Conference in San Francisco from the 7th to the 10th of January 2019.

For further information or to arrange a one-on-one meeting with Mithra’s management team in San Francisco, please contact:

Brandon Weiner – Westwicke Partners
Associate – Baltimore
+1-443-450-4190
Brandon.weiner@westwicke.com

 

Mithra Announces Complex Therapeutics Update

  • Positive study results from three-month formulation of Zoreline®, allowing progression to final clinical studies
  • Pivotal trial will commence in Q1 2019, as previously expected
  • Licensing agreement signed with UAE-based ITROM Pharmaceutical Group

Liège, Belgium, 21 December 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces positive results from its three-month PK Zoreline® study, and a licensing agreement for two products with UAE-based company ITROM Pharmaceutical Group (ITROM).

Mithra Announces Myring™ Update

  • Mithra’s US partner Mayne Pharma receives complete response letter for Myring™
  • Increased manufacturing capacity to meet market demand following licensing deals with market leaders in the US, Austria, Czech Republic, Chile, Denmark, Russia, Australia and New Zealand
  • Launch of Myring™ EU production in January 2019

Liège, Belgium, 14 December 2018, 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its US commercial partner Mayne Pharma LLC 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 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.