Associated tags: Brussels Stock Exchange, MITRA, Estetrol, Woman, Pharmaceutical industry, Menopause, Safety, CEST
Locations: LIÈGE, BE, CANADA, NORTH AMERICA, BELGIUM, SEARCHLIGHT, LATIN AMERICA, EUROPE
Negotiation,
Sale,
Gedeon Richter,
Health,
E4,
EUR,
Brussels Stock Exchange,
Highbridge Capital Management,
MITRA,
Facility,
Security (finance) Mithra remains committed to negotiating with prospective buyers to enhance value, acting in the best interest of all stakeholders (see also press release of 29 April 2024 in this respect).
Key Points:
- Mithra remains committed to negotiating with prospective buyers to enhance value, acting in the best interest of all stakeholders (see also press release of 29 April 2024 in this respect).
- The trading of Mithra shares on Euronext Brussels remains suspended pending the on-going negotiations.
- On 5 March 2024, Mithra announced the launch of a comprehensive monetization process, exploring potential sales of selected assets, notably Estetra SRL, and potentially the entire business.
- The lenders under the Facility consist of funds managed by Highbridge Capital Management, LLC and funds managed by Whitebox Advisors, LLC.
Mithra Advances Monetization Process with Court Protection Measures, marking significant milestones in the company's commitment to maximizing value for stakeholders while ensuring operational continuity.
Key Points:
- Mithra Advances Monetization Process with Court Protection Measures, marking significant milestones in the company's commitment to maximizing value for stakeholders while ensuring operational continuity.
- LIEGE, Belgium, April 22, 2024 (GLOBE NEWSWIRE) -- Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, today announces the Liege Company Court has granted the company two crucial protection measures, further advancing its monetization process and ensuring the continuity of its activities.
- These court protection measures mark significant milestones in Mithra's on-going monetization process and underscore the company's commitment to maximizing value for all stakeholders.
- These protection measures apply to the two aforementioned Mithra subsidiary companies and not to the Mithra group.
Retrieved on:
Tuesday, February 6, 2024
Liege, Belgium, 6 February 2024 – 07:00 CET - Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, today provides an update on its current cash position and its plans to address its runway and creating and optimizing value for all its stakeholders.
Key Points:
- Liege, Belgium, 6 February 2024 – 07:00 CET - Mithra (Euronext Brussels: MITRA), a company dedicated to women’s health, today provides an update on its current cash position and its plans to address its runway and creating and optimizing value for all its stakeholders.
- As of today, Mithra has sufficient cash through early March.
- As a result, Mithra has entered discussions with its secured lenders to extend its cash runway.
- Mithra will also be approaching existing and new investors and take other cash preservation measures.
Retrieved on:
Thursday, December 21, 2023
Estetrol,
Woman,
LTD,
Menopause,
Brussels Stock Exchange,
Liège,
Hot,
Laboratory,
EUR,
MITRA,
Safety,
Pharmaceutical industry DONESTA® is Mithra’s investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of menopause.
Key Points:
- DONESTA® is Mithra’s investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of menopause.
- Rafa Laboratories will have the exclusive commercial rights for DONESTA® in Israel and the Palestinian Territories on the signing of the final license and supply agreement — planned in Q1 2024.
- Mithra is eligible to receive a total of EUR 2.05 million sales-related milestones, along with tiered double-digit royalties on annual net sales.
- David Horn Solomon, CEO of Mithra stated, “We are thrilled that Mithra and Rafa Laboratories will work together to offer DONESTA® to women who suffer from the symptoms of menopause.
Retrieved on:
Wednesday, December 20, 2023
Estetrol,
Adolescence,
Woman,
EMA,
Bleeding,
Brussels Stock Exchange,
Ageing,
Liège,
European Medicines Agency,
PIP,
MITRA,
Safety,
Female,
SPC,
EudraCT Study recruited more than 100 adolescents, with primary aim to evaluate safety profile
Key Points:
- Study recruited more than 100 adolescents, with primary aim to evaluate safety profile
Liege, Belgium, 20 December 2023 – 17:45 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of a pediatric study of its marketed contraceptive ESTELLE® in adolescent women.
- The primary endpoint of the study, which is being conducted in Estonia, Finland, Georgia, Latvia, Poland and Sweden, is to evaluate the safety of ESTELLE® in post-menarchal subjects.
- Graham Dixon, Chief Scientific Officer of Mithra, commented, “The completion of this pediatric study on schedule is another important milestone for Mithra.
- Mithra is undertaking this study under a Pediatric Investigation Plan (PIP) agreed with the European Medicines Agency (EMA).
Retrieved on:
Monday, December 18, 2023
DSMB,
Quality of life,
Food,
Metabolism,
Estetrol,
Risk,
Woman,
VMS,
FDA,
EMA,
E4,
Menopause,
Brussels Stock Exchange,
Trial of the century,
NDA,
C301,
European Medicines Agency,
MITRA,
Safety,
Data monitoring committee,
Pharmaceutical industry Positive efficacy top line results have been previously reported from the menopause phase 3 program, including the European trial.
Key Points:
- Positive efficacy top line results have been previously reported from the menopause phase 3 program, including the European trial.
- Graham Dixon, Chief Scientific Officer of Mithra, commented, “This DSMB recommendation allows us to continue the extension of the DONESTA® phase 3 trial in Europe, which will generate important data for our marketing authorization applications.
- Promising top-line safety results from the phase 3 trial in North America (C302) were announced in 2023, and primary safety data from the European trial are expected in H1 2024.
- This additional safety data is foreseen to be included in the European Medicines Agency (EMA) and FDA submissions, planned within the same time frame.
Retrieved on:
Thursday, November 30, 2023
Marketing,
Quality of life,
Food,
Metabolism,
Learning,
Woman,
VMS,
Research,
IVF,
EMA,
FDA,
Menopause,
Brussels Stock Exchange,
Stifel,
NDA,
Fertility,
European Medicines Agency,
MITRA,
Safety,
Pharmaceutical industry This follows an agreement in principle with the FDA for Mithra to conduct additional endometrial data analyses.
Key Points:
- This follows an agreement in principle with the FDA for Mithra to conduct additional endometrial data analyses.
- As a result, the formal NDA submission is now planned for Q4 2024 to allow for the time required to perform these additional analyses pursuant to FDA guidance.
- Mithra is actively continuing the process of collecting and providing all required data to the FDA for submission.
- Mithra will continue to progress discussions with potential partners in parallel to the NDA submission process.
Retrieved on:
Tuesday, November 7, 2023
MITRA,
ASX,
Patent,
Liver,
United States Patent and Trademark Office,
Tablet,
1836 U.S. Patent Office fire,
Pregnancy,
CET,
Woman,
Brussels Stock Exchange,
Estetrol,
MYX,
Pharmaceutical industry,
Birth control Liege, Belgium, 07 November 2023 – 07:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that it has been granted an additional patent for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States.
Key Points:
- Liege, Belgium, 07 November 2023 – 07:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that it has been granted an additional patent for NEXTSTELLIS® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) in the United States.
- Granted by the United States Patent and Trademark Office, the new patent will provide NEXTSTELLIS® with oral-dosage-unit protection in the US market until 2036.
- Mithra’s commercialization partner, Mayne Pharma Group Limited (ASX: MYX), holds the license and supply agreement for NEXTSTELLIS®/ESTELLE® in the United States since 2021.
- David Horn Solomon, CEO of Mithra: “We are excited to have been granted this additional patent coverage for ESTELLE® under the trademark NEXTSTELLIS®, an oral contraceptive with a novel estrogen, in the United States.
MITRA,
Abdominal pain,
Headache,
Health,
Menopause,
Diarrhea,
Liver,
California Healthcare Institute,
CEST,
Research,
Nausea,
Dysmenorrhea,
Growth,
Pregnancy,
Irritability,
Partnership,
Menstruation,
Weakness,
ASEAN,
Fuji,
Depression,
Somatic symptom disorder,
Nikkei,
Brussels Stock Exchange,
Birth,
Patient,
Back pain,
Fatigue,
Pharmaceutical industry,
Birth control,
Estetrol The submission marks another key milestone in the agreement for which Mithra will receive a EUR 2.5 million milestone payment.
Key Points:
- The submission marks another key milestone in the agreement for which Mithra will receive a EUR 2.5 million milestone payment.
- Fuji Pharma obtained the right to commercialize both ESTELLE® and DONESTA® in Japan and the ASEAN region in 2016, targeting a potential market of 330 million patients.
- David Horn Solomon, CEO at Mithra: “We are very proud of our partnership with Fuji Pharma and today’s announcement marks another key milestone in Mithra’s drive for growth and achieving its mission.
- The global dysmenorrhea market was worth EUR 257 million in 20221.
Retrieved on:
Monday, September 11, 2023
Highbridge,
Letter,
Partnership,
Therapy,
Marketing,
API,
Woman,
Hospira,
Fertilisation,
Sale,
MITRA,
EUR,
CDMO,
CEST,
Brussels Stock Exchange,
Menopause,
White box,
Management,
Financial services,
Pharmaceutical industry,
Estetrol Liege, Belgium, 11 September 2023 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, (the “Company” or “Mithra”), today published a Letter to Shareholders and Corporate Update from Chief Executive Officer, Dr. David Horn Solomon.
Key Points:
- Liege, Belgium, 11 September 2023 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, (the “Company” or “Mithra”), today published a Letter to Shareholders and Corporate Update from Chief Executive Officer, Dr. David Horn Solomon.
- We raised EUR 20 million in a successful equity financing, with potential for up to an additional EUR 45 million in equity.
- I hope that you will agree that these achievements are significant and consistent with the strategy we set forth in our shareholder letter in May.
- Mithra’s executive leadership is working closely and in lock-step with our Board of Directors to execute on our strategy.
