Mithra Signs License and Supply Agreement for Commercialization of Tibelia® in Chile

  • Mithra strengthens its presence in the fast-growing Chilean market with an agreement for commercialization of the hormone treatment Tibelia® with Saval Pharmaceuticals
  • Tibelia® is currently marketed in about ten countries through existing license and supply agreements and just adds an additional market in Spain after winning a public tender

Liege, Belgium, 05 March 2019 – 7 :30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces that it has entered into a license and supply agreement with Saval Pharmaceuticals to commercialize Tibelia® in Chile.

Mithra Reports 2018 Annual Results

  • Strong revenue growth (+42%) with significantly improved EBITDA (record level of EUR 38.3 M vs. EUR -18.4 M in 2017) and cash position (EUR 119 M vs. EUR 36.2 M in 2017) thanks to increased business development activities
  • Strengthening Mithra’s international deployment through key partnerships with women’s health leaders
  • Clinical milestones successfully achieved for highly promising portfolio E4 (Estetrol)-based pipeline, including the 5th generation contraceptive pill Estelle® and next-generation menopause therapy Donesta®
  • Additional potential E4-based blockbuster for the underserved perimenopause market with PeriNesta™ in development (which brings Mithra’s late clinical stage pipeline to a total of 3)

Liege, Belgium, 01 March 2019– 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its results for the year ended 31 December 2018, prepared in accordance with IFRS.

Mithra Signs Partnership Agreement With Itrom for Commercialization of Estelle® in the Middle East

  • Mithra strengthens its presence in the Middle East with a third partnership with UAE-based ITROM Pharmaceutical Group for the combined oral contraceptive Estelle®
  • Following the publication of the positive top-line results of the Estelle® Phase III study, Mithra is intensifying its business development strategy of its potential contraceptive blockbuster in key international markets
  • Agreement follows licensing deals for Estelle® with market leaders in Europe, Russia, Canada, Brazil, Japan, South Africa and South Korea

Liege, Belgium, 28 February 2019 – 7 :30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces that it has signed a 20-year binding Head of Terms agreement with ITROM Pharmaceutical Group (ITROM) for the commercialization of Estelle® in the Middle East. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate, containing 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).

Information on the Total Number of Voting Rights (Denominator)

Liege, Belgium, 25 February 2019 – 17:45 CET – In accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Mithra Pharmaceuticals SA announces the following information, following the issuance of 24,750 new shares on 30 January 2019 for an amount of EUR 84 690 as the result of the exercise of 15 subscription rights (warrants) pursuant to the warrant plan initiated on 2 March 2015. Following this capital increase, Mithra now has 37.664.245 outstanding shares carrying voting rights (37,639,495 outsanding shares previously).

Therefore, Mithra publishes the updated following information :

  • Share capital: EUR 27,573,880.18
  • Total number of securities carrying voting rights: 37,664,245 (all ordinary shares)
  • Total number of voting rights (= denominator): 37,664,245 (all relating to ordinary shares)
  • Number of rights to subscribe securities carrying voting rights not yet issued:
    • Pursuant to the warrant plan of 2 March 2015: 635 warrants giving right to 1,047,750 shares
    • Pursuant to the warrant plan of 5 November 2018: 1,238,339 warrant giving right to 1,238,339 shares

Mithra Announces New Polymer Technology Development for a Leading Veterinarian Company

  • First veterinary R&D project concluded with one of the world’s largest animal health players, CEVA
  • Development of an innovative hormonal device for the bovine fertility market
  • Expansion of Mithra CDMO polymer technology expertise attracts new development partners

Liege, Belgium, 20 February 2019 – 7:30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health announces today that it has signed a contract with the CEVA Animal Health group to develop a hormonal device for the veterinary market. CEVA Animal Health is one of the ten largest veterinary pharmaceutical groups in the world and develops products that meet the specific needs of the various sectors of this market, particularly bovines.

Mithra Successfully Produces its First Commercial Batch of Myring™ for Europe

• Crucial step taken by Mithra CDMO facility in Belgium with the production of first batch of Myring™, starting the commercial manufacturing process
• Production of commercial batches for the European markets on target
• Production capacity to be tripled, thanks to investment in state-of-the-art technology

Liege, Belgium, 13 February 2019 – 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that its development and production center has successfully produced its first commercial batch of Myring™ for the European market. This first order of the vaginal contraceptive ring will be sold in the Czech Republic, a market worth approximately EUR 1.3 million . This production follows a 10-year non-exclusive license and supply agreement with the Polish company Adamed Group (Adamed) in December 2017.


 

Mithra Signs Exclusive License and Supply Agreement for Commercialization of Myring™ in the Middle East

  • Mithra strengthens its collaboration with UAE-based ITROM Pharmaceutical Group with a consolidated deal to generate at least EUR 14 million
  • Product to be manufactured at Mithra CDMO facility in Belgium
  • Agreement follows licensing deals for Myring™ with market leaders in the US, Europe, Russia, Australia and Chile

Liège, Belgium, 12 February 2019 – 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces an exclusive 20-years license and supply agreement with ITROM Pharmaceutical Group (ITROM) for the commercialization of its combined hormonal contraceptive vaginal ring in the Middle East.

Mithra Strengthens Management Team With Key Appointments

  • Expansion of IR and Communications functions to support the execution of Mithra’s strategy

Liège, Belgium, 4 February 2019 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has strengthened its IR and Communications functions with the appointments of Ms. Alexandra Deschner as Investor Relations Officer and Ms. Maud Vanderthommen as Communications Manager.

 

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).