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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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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Mithra Recognized by the Scientific Community: the Contraception Journal Publishes a Scientific Article About E4 (Estetrol) FIESTA Phase II Study

  • Mithra Pharmaceuticals announces today the publication of a scientific article based on the results of the E4 FIESTA Phase II study of its estetrol-based product candidate Estelle®, a combined oral contraceptive composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP).
  • The article describes the bleeding pattern and cycle control observed with different E4 combinations.
  • The published results are very interesting for the scientific community as they demonstrate the good bleeding profile of the Estetrol-based product candidate Estelle®, which will be confirmed in the coming phase 3 studies.

Liège, Belgium, 4 May 2016 – Mithra Pharmaceuticals announces today that an article has been published in the peer-reviewed Contraception Journal. The published results of the E4 FIESTA Phase II study are particularly encouraging for the imminent launch of the Phase III studies.

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Mithra’s European Advisory Board for Estelle Will Meet During the ESC Congress (European Society of Contraception) in Basel on May 4th 2016

  • Mithra has set up a scientific committee composed of international experts to support the last development steps of Estelle®, its contraceptive product candidate based on Estetrol.
  • The European or American scientific committees, set up by Mithra and its own scientific committee, are aimed at gathering impressions and recommendations from the international experts in the contraception field. These committees will be moderated by Mitchell Creinin, global expert in contraception of the Davis University in Sacramento, California.
  • During the ESC (European Society of contraception) held in Basel from May 5th to 7th, 2016, Mithra will gather its experts and practitioners board and will present the last results of the project Estelle to the scientific community during a symposium entitled „Estelle, new contraceptive pill with fetal estrogen, Estetrol“

Liège, Belgium, 3 May 2016 – In order to support the last development steps and to prepare its candidate product for a future introduction on the market, Mithra set up an international and European advisory committee. Composed of 7 international European experts in gynecology, this committee will advise Mithra on its development, but also on the clinical relevance and the added value of Estetrol in the contraception field. These Key Opinion Leaders will work with Mithra in order to confront development plans with market needs. The next committee meeting is planned on May 4th in Basel, Switzerland, during the ESC Congress (European Society of contraception and Reproductive Health) and will be moderated by Mitchell Creinin, a world expert in contraception.

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3 Out of 5 European Countries Selected Have Fully Approved Protocol of Phase II Clinical Study Donesta®-Mit-Do001-C201. 8 Out of 9 European Countries Selected Have Fully Approved Protocol of Phase III Clinical Studies Estelle®- Mit-Es001-C301.

  • The authorities of 3 out of 5 countries give green light to start the Phase II clinical study of the Estetrol-based product candidate dedicated to vasomotor menopausal symptoms (VMS) treatment on menopausal women (Donesta®) on their territories.
  • In parallel, Mithra announces: 8 out of 9 countries selected to host Phase III clinical trials for Mithra’s contraceptive product candidate based on Estetrol (Estelle®) in Europe have already fully approved the clinical trials protocol.
  • The progress of the clinical programs regarding the Estetrol-based products candidate (Donesta®and Estelle®) are in line with objectives and remains on Mithra’s schedule.

Liège, Belgium 29 April 2016 – On the 5 countries selected to host Phase II clinical trial for Mithra’s HRT (Hormone Treatment Therapy) candidate based on Estetrol (Donesta®) in Europe, 3 already fully approved the clinical trial protocol.

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FDA Feedback on SPA Estelle®: a New Step Closer to the Launch of Estelle® Phase III Pivotal Clinical Studies

  • Mithra received feedback on the SPA (Special Protocol Assessment) of the FDA (Food and Drug Administration) regarding its Estelle® Phase III Protocol.
  • At the clinical protocol level, only minor recommendations and requests for clarification were expressed by the FDA.
  • This feedback is comforting and in line with objectives and remains on Estelle® Phase III schedule.

Liège, Belgium 05 April 2016 After receiving encouraging news from the different European countries regarding the Estelle® Phase III pivotal clinical studies under approval, Mithra Pharmaceuticals announces today that the FDA (Food and Drug Administration) also gave encouraging feedback regarding the Estelle® Phase III pivotal clinical study protocol in the United States. Mithra already has the answers at its disposal and will provide them through the IND (Investigational New Drug) submission as planned in the course of June 2016. At the clinical level, only minor recommendations and requests for clarification were expressed by the FDA.

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Topline Results of Food Effect Study of the Product Candidate Estelle®, the new combined oral contraceptive composed of 15mg of Estetrol (E4) and 3mg of Drospirenone (DRSP)

Liège, Belgium 01 April 2016 –  Mithra announces the results of the Food Effect Study of the product candidate Estelle. The study demonstrated that the concomitant food intake with a single dose of Estelle in women resulted in a decrease for Estetrol and Drospirerone rate of absorption (Cmax) while the extent of exposure (AUC) of both Estetrol and Drospirenone was not impacted. This was the result that Mithra wanted to obtain from the study.

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