Estetrol

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Medical Subject Headings, Marketing, Artery, Pregnancy, Estetrol, INN, Pearl, Risk, Progesterone, Woman, IIA, ATC, Bleeding, International, Headache, Ageing, Language, Mouth, Tablet, Dysmenorrhea, Acne, Birth control, European Medicines Agency, Blister, Menstrual cycle, Pearl Index, Select, Birth, Patient, Vein, Safety, Cancer, Checklist, Anatomy, Vaginal bleeding, Internal bleeding, Ovulation

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Liver, Medical Subject Headings, Marketing, Artery, Pregnancy, Coronary thrombosis, Estetrol, INN, Risk, Pearl, Progesterone, Woman, IIA, ATC, Health system, Bleeding, International, Headache, Ageing, Language, VTE, Mouth, Tablet, Dysmenorrhea, Acne, Birth control, European Medicines Agency, Blister, Menstrual cycle, Pearl Index, Select, Birth, Patient, Vein, Safety, Cancer, Checklist, Anatomy, Vaginal bleeding, Internal bleeding, Ovulation

Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Lydisilka, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 4, Status: Authorised

Mithra and Rafa Laboratories sign binding Head of Terms to commercialize DONESTA® in Israel

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.

Mithra Completes Pediatric Study of ESTELLE® in Adolescent Patients

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).

Mithra Receives Positive DSMB Opinion on DONESTA® European Phase 3 Trial

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.

Mithra’s NEXTSTELLIS® granted additional patent in the United States

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.

Mithra to receive EUR 2.5 million milestone payment from Fuji Pharma under ESTELLE® licensing agreement

Retrieved on: 
Monday, October 23, 2023
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.

Letter to Shareholders and Corporate Update

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.

Mithra and Searchlight Pharma Announce Donesta® Licensing Agreement for Canada

Retrieved on: 
Monday, July 31, 2023
Health, Consumer, Women, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Partnership, Development, Woman, Multimedia, MITRA, Trust, Estrogen, Brussels Stock Exchange, Menopause, Safety, Pharmaceutical industry, Birth control, Mithra, Estetrol

View the full release here: https://www.businesswire.com/news/home/20230731182336/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230731182336/en/
    Under the binding terms, Searchlight will have the exclusive sales and marketing rights for Donesta® in Canada.
  • Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell Donesta® in Canada.
  • David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are very pleased to reach this agreement with Searchlight Pharma for the licensing of Donesta® in Canada.
  • Mithra and Searchlight have a continuing partnership for NEXTSTELLIS®, a combined oral contraceptive product based on Estetrol, and HALOETTE®, a vaginal contraceptive ring in Canada.

Mithra and Searchlight Pharma Announce Donesta® Licensing Agreement for Canada

Retrieved on: 
Monday, July 31, 2023
Partnership, Drug development, Development, Birth, Woman, Liège, MITRA, Trust, CEST, Estrogen, Brussels Stock Exchange, Menopause, Health, Safety, Pharmaceutical industry, Birth control, Mithra, Estetrol, Euronext

Under the binding terms, Searchlight will have the exclusive sales and marketing rights for Donesta® in Canada.

Key Points: 
  • Under the binding terms, Searchlight will have the exclusive sales and marketing rights for Donesta® in Canada.
  • Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell Donesta® in Canada.
  • David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are very pleased to reach this agreement with Searchlight Pharma for the licensing of Donesta® in Canada.
  • Mithra and Searchlight have a continuing partnership for NEXTSTELLIS®, a combined oral contraceptive product based on Estetrol and HALOETTE®, a vaginal contraceptive ring in Canada.