Tibelia®, First Tibolone-Based Hormone Therapy Approved in Canada

  • The Canadian Health authorities have granted the Marketing Authorization for Tibelia®, the company’s tibolone-based product for use in Hormone Therapy (HT).
  • First tibolone-based hormone treatment to be available in Canada, offering a true new option for women with a proven efficacy, tolerability and safety profile
  • The introduction of Tibelia® in Canada plays a crucial role in the international commercial expansion strategy in key attractive markets like the United States

Liege, Belgium, 15 May 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that Health Canada, the Canadian Health authorities, has approved Tibelia® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause. Developed by Mithra as bioequivalent version of Livial®, Tibelia® is a synthetic steroid that relieves postmenopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.

 

Mithra Signs License and Supply Agreement for Commercialization of Myring™ in Latin and South America

  • Mithra grants exclusive 10-year license to Megalabs for commercialization of vaginal contraceptive ring in Argentina, Paraguay and the Dominican Republic
  • Product to be manufactured at Mithra CDMO facility in Belgium
  • Agreement follows licensing deals for Myring™ with international market leaders in the U.S., Europe, Russia, Australia, Middle East and Chile
Liege, Belgium, 25 April 2019 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into an exclusive license and supply agreement with the pharmaceutical group Megalabs for the commercialization of its vaginal contraceptive ring Myring™ in Latin America and South America. Based in Uruguay, Megalabs develops a wide range of market-leading pharmaceutical products in twenty Latin American countries.

Mithra announces new agreement with GSP for development of an additional injectable

  • Agreement with Generic Specialty Pharma (GSP), a leading generics player, for development and supply of a fifth hormonal injectable.
  • Expansion of Mithra CDMO’s portfolio of activities, confirming its profile as a unique industrial partner in the development and production of a complete range of specialized medical products and devices.

Liege, Belgium, 18 April 2019 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into a new agreement with Generic Speciality Pharma (GSP) for the development and supply of a sterile hormonal injectable product at Mithra CDMO. Headquartered in Dublin, GSP is part of the Alter Pharma group, a Belgian pharmaceutical conglomerate focused on the development and manufacturing of niche generics, complex generics and high added value products.

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 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.