Mithra and Adamed Sign Commercialization Agreement for Myring™ in the Czech Republic

  • Mithra grants non-exclusive 10-year license for vaginal contraception ring MyringTM to Adamed for commercialization in the Czech Republic
  • Agreement follows US and Austrian license granted to Mayne Pharma and Gynial, respectively
  • MyringTM to be manufactured at Mithra CDMO

Liège, Belgium, 27 December 2017 –  Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced a non-exclusive, 10-year license and supply agreement with Adamed Group (Adamed), for the commercialization of MyringTM, Mithra’s combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), in the Czech Republic. Adamed is a Polish pharmaceutical and biotechnology company with a focus on gynaecology. Financial details of the agreement were not disclosed.

Mithra Announces Injectables Agreement with GSP

  • Mithra closes contracts with leading generics player GSP for development and supply of 4 hormonal injectables
  • Contracts should allow for European and US GMP approval of injectable section at Mithra CDMO
  • Strong validation by reputable partner of know-how and capabilities of Mithra CDMO

Liège, Belgium, 14 December 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces an agreement with GSP for the injectables section of the Mithra CDMO. The umbrella agreement comprises the development and production of four products. GSP (Generic Speciality Pharma), based in Northern Dublin (Ireland), is a leading player in generic healthcare products. The company, part of the Alter Pharma group, works with 3rd party manufacturers in a large number of geographies and outlicenses its product portfolio to partners worldwide.

Mithra Finalizes Estelle® Contract with Brazilian Women’s Health Leader Libbs

  • Mithra is eligible for a EUR 20 million upfront milestone payment, with EUR 14 million to be received in 2017
  • 20-year contract grants Libbs an exclusive commercial license as well as manufacturing rights for Estelle® in Brazil, in addition to a cost-effective alternative supply option for key APIs (Active Pharmaceutical Ingredients)
  • Contract forms part of Mithra’s strategy to realize full potential of pipeline programs through global partnerships with leaders in Women’s Health

Liège, Belgium, 11 December 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce finalization and signature of the contract with Libbs, the Women’s Health leader in Brazil, for an exclusive license to Estelle® in Brazil. This follows the binding Heads of Terms announced in September 2017. Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estelle® is currently in Phase III trials in the US and Canada as well as in Europe and Russia, with top line results expected in Q3 2018 and Q1 2019, respectively.

Mithra Announces Valorization of French Subsidiary

Liège, Belgium, 7 December 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces that it successfully divested its French affiliate, Mithra France.

Mithra Provides Update on Estelle® and Donesta® Studies

Liège, Belgium, 30 November 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces an update on the clinical study progress for its two lead Estetrol (E4) based product candidates, Estelle® (E4 Freedom) and Donesta® (E4 Relief).

Mithra Confirms Conversion of Subscription Rights

Liège, Belgium, 29 November 2017 – 18:00 – Regulated Information – Following press release issued on 30 October 2017, Mithra (Euronext Brussels: MITRA) today confirms, in conformity with Title II of the Law of 2 May 2007 and the Royal Decree of 14 February 2008, that an additional 724,350 ordinary shares have been issued by the Company for an amount of EUR 2,478,594 as the result of the exercise of 439 subscription rights (warrants).

Mithra Announces 36-month Shelf Life Extension for Tibelia®

  • Extended shelf-life offers competitive advantage over current tibolone-based products, including originator product Livial®
  • Tibelia® is currently marketed in 5 countries through existing supply and license agreements, with further contracts and product launches planned in coming months

Liège, Belgium, 22 novembre 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today confirms the extended shelf-life of 36 months of its complex therapeutic product Tibelia®, as compared to 24 months for other currently available tibolone-based products.

Mithra Announces Positive Outcome of Myring™ Commercial Batch Bioequivalence Study

  • Bioequivalence study performed on commercial Myring™ batch produced at Mithra CDMO
  • Data will form part of planned Myring™ FDA filing by US partner Mayne Pharma

Liège, Belgium, 17 November 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces the successful outcome of a confirmatory bioequivalence study performed on a commercial batch of Myring™ produced at the Mithra CDMO. The study results reconfirm that Myring™ is bioequivalent to Nuvaring®, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).

Mithra Announces Launch of Warrant Exercise Period

Liège, Belgium, 30 October 2017 – Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the launch of an exercise period of its warrant plan initiated on 2 March 2015.

Mithra Completes Recruitment for Estelle® Phase III Study in US and Canada

  • Estelle® Phase III study in US/Canada remains on track to report top line data in Q1 2019
  • Study recruited 2148 women in total; 57% of subjects already completed over half the 13 treatment cycles
  • First subject completed the 13 cycle treatment as well as the end of study visit in October

Liège, Belgium, 30 October 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces the completion of recruitment in the E4 Freedom Phase III study of Estelle® in the US and Canada. Estelle® is Mithra’s combined oral contraceptive (COC) candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Top-line data, based on 13 cycles of treatment, remain on track to be reported in the first quarter of 2019.