Mithra Announces FDA update

  • Mithra’s US partner Mayne Pharma receives complete response letter from FDA for Myring™ requesting additional data that is not normally requested for generic products
  • Based on the information available to date, Mithra expects to have the necessary data in hand to respond to FDA before year-end
  • No questions or comments have been raised by FDA with regard to Mithra CDMO, which provides comfort regarding robustness of manufacturing process
  • Mid-cycle review with FDA regarding the New Drug Application (NDA) for Estelle (Nextstellis) raised no substantive issues
  • Solid cash position and funding facilities to cover working capital needs

Liege, Belgium, 6 October 2020 – 07:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX: MYX)  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 Commercial Launch of Myring™ in the Netherlands

Liege, Belgium, 19 August 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of its vaginal contraceptive ring Myring™ in the Netherlands.

Mithra Announces Shelf Life Extension for Myring™ to 36 Months

  • Shelf life extended from 24 to 36 months in Europe
  • Competitive advantage in terms of optimizing the supply chain costs and convenience for distributors, pharmacists and patients

Liege, Belgium, 4 August 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that the European Authorities have approved the extension in the shelf life of its vaginal contraceptive ring Myring™ from 24 to 36 months, allowing distributors to optimize their supply chain management.

Mithra Announces Commercial Launch of Tibelia® in Canada

  • First tibolone-based hormone treatment available in Canada, offering a new treatment option for menopausal women
  • Mithra’s product commercialized by BioSyent Pharma for a growing annual market value of
    EUR 132 million
  • Canadian launch generates additional revenues for Mithra through sales related milestones

Liege, Belgium, 30 July 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of tibolone-based product Tibelia® in Canada. Developed by Mithra as the bioequivalent version of Livial®1, 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 other medicinal products. Mithra’s product is marketed by BioSyent Pharma Inc. (TSX  Venture Exchange: RX) in Canada under the trademark name Tibella®.

Mithra Signs License and Supply Agreement for Commercialization of Myring™ in Mexico

  • Mithra grants exclusive license to Megalabs for commercialization of its vaginal contraceptive ring in Mexico
  • Strengthening of the commercial presence in Latin and South America thanks to this second contract with Megalabs
  • Myring™ licenses granted to industry leaders in 35 countries, including the world’s three largest markets

Liege, Belgium, 14 July 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into a license and supply agreement (LSA) with Megalabs for the commercialization of its hormonal contraceptive ring Myring™ in Mexico. Based in Uruguay, Megalabs develops a wide range of market-leading pharmaceutical products in twenty Latin American countries

Mithra Signs LSA for Commercialization of Myring™ in France, Poland and United Kingdom

  • Mithra grants license to Zentiva for commercialization of its vaginal contraceptive ring in three key European markets
  • Consolidation of commercial roll-out in Europe with 17 countries already under license
  • Production ongoing at Mithra CDMO for upcoming European commercial launches

Liege, Belgium, 06 July 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that it has entered into a license and supply agreement (LSA) with Zentiva for the commercialization of its hormonal contraceptive ring Myring™ in France, Poland and the United Kingdom. Based in Czech Republic, Zentiva is a pharmaceutical company with more than 4,700 people and a network of production sites – including flagship sites in Prague, Bucharest, and Ankleshwar.

Mithra Signs LSA for Commercialization of Tibelia® in Liechtenstein and Switzerland

  • Mithra grants license to Spirig Healthcare (Stada Group) for commercialization of its hormone treatment Tibelia® in Liechtenstein and Switzerland
  • Tibelia® is currently marketed in about 30 countries through existing license and supply agreements

Liege, Belgium, 11 June 2020 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has entered into a license and supply agreement with Spirig Healthcare AG for the commercialization of its tibolone-based product Tibelia® in Liechtenstein and Switzerland.

Mithra and Gynial Sign Commercialization Agreement for Myring™ in Switzerland

  • Mithra grants license for its vaginal contraceptive ring to Gynial for commercialization in Switzerland
  • Strengthening its partnership with Women’s Health specialist Gynial, already responsible for the Austrian market
  • Large-scaled global commercialization of Myring™ after first successful launches in Europe

Liege, Belgium, 05 May 2020 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into a license and supply agreement (LSA) with Gynial GmbH for the commercialization of its hormonal contraceptive ring Myring™ in Switzerland.

Mithra Announces Commercial Launch of Myring™ in Germany, the biggest market in Europe

  • Successful launch of Mithra’s hormonal contraceptive ring in Germany under the trademark MYCIRQ®
  • Germany is the largest European market and the second worldwide, with 3 million vaginal rings sold per year
  • Mithra CDMO pursues the manufacturing of its Myring™ orders in compliance with all the measures required by the Belgian authorities

Liege, Belgium, 2 April 2020 – 7:30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the commercial launch of Myring™ in Germany, which is the largest European market and the second worldwide in terms of sales volume. With 3 million vaginal rings sold per year, the German contraceptive rings market is worth EUR 27 million per year.

 

Mithra Announces Commercial Launch of Myring™ in Belgium

  • Mithra’s hormonal contraceptive ring is now available in pharmacies in Belgium under the trademark name Myloop®
  • Large-scaled global commercialization of Myring™, especially in the world’s three largest markets
  • Mithra CDMO in Belgium expected to produce nearly 2 million rings in 2020

Liege, Belgium, 12 February 2020 – 7:30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the commercial launch of Myring™ in Belgium. The Belgian contraceptive ring market is valued at around EUR 5.1 million, with more than 600,000 rings sold each year. Mithra’s vaginal contraceptive ring is marketed by Ceres Pharma in Belgium under the trademark name Myloop®.