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 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 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.

Mithra Signs Exclusive License and Supply Agreement for the Commercialization of Myring™ in Chile with Laboratorio Pasteur

Liège, Belgium, 26 September 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce the finalization and signature of the contract with Laboratorio Pasteur S.A., a Chilean pharmaceutical company also devoted to women’s health, for an exclusive License and Supply Agreement (LSA) to commercialize Myring™ in Chile.

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

Liège, Belgium – 21 September 2018, 07:30 CEST – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announced that it has entered into an exclusive license and supply agreement with Pei Li Pharmaceutical Industrial Co, Ltd (“Pei Li Pharm”) to commercialize Tibelia® in Taiwan.

Mithra Announces Belux Agreement with Ceres Pharma Worth over EUR 40 Million

  • Mithra to receive EUR 20 million upon signing, with further EUR 20 million in potential additional earn-outs
  • Agreement covers the sale of the Women’s Health branded generics business in Belgium and Luxembourg as well as License and Supply agreements for certain Mithra assets in the region
  • Divestment of BeLux portfolio in line with Mithra’s strategy to realize the value of its noncore assets and fully focus on its key value-driving pipeline
Liège, Belgium, 30 July 2018, 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has signed a comprehensive BeLux partnership with Ceres Pharma, a Belgium-based company focused on over-the-counter (OTC) and specialist healthcare.

Mithra Obtains First Marketing Authorization for Myring™ in Europe

  • Marketing authorization allows for launch of Myring™ in the United Kingdom
  • Additional marketing authorizations expected in the near future
  • Mithra to produce Myring™ at its CDMO
Liège, Belgium, 20 July 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the company obtained its first marketing authorization (MA) for Myring™  in the UK, following approval by the MHRA . Myring™ is Mithra’s contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA) and is developed to be fully bioequivalent to Merck’s Nuvaring®.  In April 2018, Nuvaring® went off patent in both the US and Europe. In the UK, which is a market worth approximately EUR 1.2 million , no generic competition exists as of yet.

Mithra and Mediner Sign LSA for Tibelia® in Hungary

  • Mithra grants exclusive license for Tibelia® to Mediner for commercialization in Hungary
  • Tibelia® is currently marketed in a 8 countries through existing license and supply agreements
  • Further Tibelia® launches anticipated in 2018

Liège, Belgium, 13 July 2018 –  Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces an exclusive license and supply agreement (LSA) with Mediner for the commercialization of Tibelia® in Hungary.