Canada Approves Clinical Trial Application for Estelle® (E4/DRSP) Phase III Study

Liège, Belgium 20 July 2016 –  Mithra announces today that the Canadian authorities approved its Clinical Trial Application (CTA) for the Phase III study for Estelle® (E4/DRSP), the Estetrol-based product candidate in contraception developed by Mithra. This great news has been received a few weeks after the enrolment of the first patient in the Phase III study in Europe. Mithra should receive a feedback from the American Food and Drug Administration (FDA) in the next few days, as well as ethic committees, representing the last step before the launch of the Phase III study in the United States and in Canada.

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Mithra Obtains a Marketing Authorisation for its Own Product Tibelia® in Spain for Which it has Two Commercial Agreements

Liège, Belgium 5 July 2016 – Mithra Pharmaceuticals announces today that it obtained a new Marketing Authorisation for the commercialization of its product Tibelia® (bioequivalent of Livial® developed by Mithra) in Spain.

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First Patient Screened for the European Product Candidate Estelle® (E4/DRSP) Phase III Clinical Study: the Phase III Has Started in Europe Ahead of Schedule

Liège, Belgium 30 June 2016 – Mithra announces today that the first patient has been screened for enrolment in the European Phase III clinical trials for its Estetrol-based product candidate Estelle® (E4/DRSP). The screening of this first patient marks the launch of the Estelle® (E4/DRSP) Phase III clinical trial in Europe.

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Mithra Pharmaceuticals Hosts its 2016 Investor Day and Reaffirms its Strategy for the Upcoming Years

Brussels, Belgium 29 June 2016 – Mithra Pharmaceuticals hosts its 2016 Investor Day today in Brussels. Through interviews with the CEO François Fornieri, members of the Executive Management and of the Scientific Committee, Mithra provides an update on its strategy and business model, as well as on its Research and Development projects one year after its Initial Public Offering.

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Mithra Signs a License and Supply Agreement with Gedeon Richter for its product Tibelia® in 6 European Territories

Liège, Belgium 28 June 2016 – Mithra announces that it signed a non-exclusive License and Supply Agreement with the Hungarian company Gedeon Richter for its product Tibelia®. Under the terms of this contract, Mithra grants Gedeon a non-exclusive license for the commercialization of Tibelia® in Italy, Switzerland, Spain, Germany, Belgium and Luxembourg.

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Mithra Signs an LOI for the Japanese and ASEAN Rights on Estetrol in Women’s Health with the Market Leader in Japan, Fuji Pharmaceuticals

  • LoI between Mithra and Fuji, market leader in Japan, for Estetrol-based products in Women’s Health; multiple indications to be determined in common agreement
  • Japanese clinical trials to be conducted and financed by Fuji
  • Potential milestones in the double-digit million EUR range

Liège, Belgium 24 June 2016 – Mithra Pharmaceuticals is pleased to announce it has signed a Letter of Intent with Fuji Pharmaceuticals to work towards a broad partnership on Estetrol in women’s health, in multiple indications to be determined in common agreement. Both parties intend to finalize their partnership in an agreement before the end of this year. This important partnership (involving investments and potential milestones in the double-digit million range) between Mithra and Fuji Pharmaceuticals, the market leader in Women’s Health in Japan, validates Mithra’s strategy of seeking out the Women’s Health leaders in markets around the world.

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Mithra Pharmaceuticals to Host Investor Day Event on June 29th, 2016 in Brussels

Liège, Belgium 25 May 2016 –  Mithra announces that it will host its Investor Day event on June 29th 2016 in Brussels from 8:30 AM to 5:30 PM in the attendance of the CEO François Fornieri, Jean-Michel Foidart as a member of the Scientific Committee and other Mithra executives.

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Inauguration of the Mithra CDMO on September 30, 2016, Three Months Ahead of Schedule; a Milestone That Bodes Well for GMP Approvals

  • Mithra announces the official opening of its future CDMO on September 30, 2016 in the presence of Mr Jean-Claude Marcourt, Minister for Economy, Industry and Innovation.
  • Phase I of the project, which consists of the production facilities for polymeric forms, implants and sterile injectables, will be operational 3 months ahead of schedule. Mithra also confirms that the construction is on track to be completed within the allocated budget.
  • Mithra invites interested people to save the date and to register for this significant step in its development by sending an e-mail to investorrelations@mithra.com.

Liège, Belgium 18 May 2016 – Mithra announces that the inauguration of its future R&D and production platform, Mithra CDMO, will take place on September 30, 2016 in Flémalle. By then, the construction of Phase I buildings will be completed, 3 months ahead of schedule and within the allocated budget. In September 2016, the CDMO will host the production of first technical batches of the product candidate Myring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA).

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Mithra Enrols its First 5 Patients for the Donesta® Phase II Clinical Study MIT-DO0001-C201

Liège, Belgium 13 May 2016 –  Mithra Pharmaceuticals, a company dedicated to Women’s Health, announces today the enrolment of its first 5 patients in Poland for its Phase II clinical trial MIT-Do0001-C201 (E4Relief) for Donesta®, its Estetrol-based product candidate in the menopause indication. This enrolment is in line with the envisaged timing and objectives, as it was planned for H2 2016, as already announced in Mithra’s IPO Prospectus.

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Mithra Launches Manufacturing of Myring First Technical and Clinical Batches

Liège, Belgium 10 May 2016 –  Mithra announces that the production of the first technical and clinical batches of Myring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), has started within its external CMO (Macors). These clinical batches will be used in the bioequivalence study.

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