Mithra Announces Positive Top-line Results of Estelle® Phase III Oral Contraceptive Study in U.S/Canada

  • Primary efficacy endpoint indicates excellent contraceptive efficacy, with a Pearl Index (PI) of 2.41 per 100 women, in line with expectations
  • Key secondary endpoints achieved, including excellent bleeding profile, cycle control, quality of life and safety and tolerability
  • Data in line with previously announced Phase III trial in EU / Russia confirming Estelle’s®outstanding profile as a novel, next-generation combined oral contraceptive
  • Filing with U.S. and EU regulatory agencies anticipated by year end

Liège, Belgium, 30 January 2019, 07:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its Phase III Estelle® study conducted in the United States and Canada successfully met its primary efficacy endpoint.

Efficacy is well in line with expectations, similar to a recently FDA approved combined hormonal contraceptive (Annovera™ PI 2.98 [95% Confidence Interval 2.13-4.06]) per 100 woman-years of use) and to Lo-Loestrin® (PI 2.92 [95% Confidence Interval 1.94-4.21]), one of the best-selling Combined Oral Contraceptives (COC) in the United States with USD 527.7 million sales in 2018 (15% yoy growth). Estelle® is Mithra’s COC candidate, composed of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.

 

Mithra announces 2019 financial calendar

Liege, Belgium, 22 January 2019 – 7:30  CET – Mithra (Euronext Brussels: MITRA), a company focused on women’s health, today announces its financial calendar for 2019 :

  • 1 March 2019 : Full Year Results 2018
  • 8 April 2019 : Annual Report 2018
  • 16 May 2019 : Annual General Shareholders Meeting
  • 19 September 2019 : Interim report 2019

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

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