- Estelle® to be the 1st Combined Oral Contraceptive (COC) based on an environmental friendly estrogen (E4)
- Environmental Risk Assessment study demonstrates absence of environmental risk for Estetrol (E4)
- E4 endocrine disruptive effects on the environment are insignificant in comparison to currently marketed estrogens commonly found in the aquatic environment
- E4 will contribute to preserve intact ground and surface waters and ecosystems in line with UN 2030 sustainable development goals
- Mithra grants exclusive license to Alvogen for commercialization of its combined oral contraceptive Estelle® in Hong Kong and Taiwan
- Agreement follows licensing deals for Estelle® with market leaders in U.S., Europe, Russia, Canada, Brazil, Japan, South Korea, Middle East and South Africa
- Recruitment of the first patient for the second pivotal Donesta® Phase III study conducted in 12 countries in Europe, Russia and South America
- “E4 Comfort” Phase III Clinical Program for Donesta® successfully launched in October 2019 with recruitment of first patient for North American study
- Phase III Program aimed at enrolling approximately 2200 menopausal women with vasomotor symptoms
Liege, Belgium, 22 October 2019 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the publication of abstracts on Estelle® clinical results presented at the 13th Annual Meeting of the European Society of Gynecology (ESG) held from 16-19 October 2019 in Vienna, Austria.
Liege, Belgium, 16 October 2019 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that its Phase III results for Estelle® will be presented at the 13th Annual Meeting of the European Society of Gynecology (ESG) taking place from 16-19 October 2019 in Vienna, Austria.
- Recruitment of the first patient marking the launch of “E4 Comfort” Phase III Clinical Program for Donesta® in menopausal women with vasomotor symptoms
- Phase III program includes two pivotal studies aimed at enrolling a total of 2200 women aged from 40 to 65 years
Liege, Belgium, 9 October 2019 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the launch of the Donesta® Phase III clinical program called “E4 Comfort”, with the recruitment of the first patient for the North American Phase III study with E4 monotherapy. Donesta® is a next generation orally-administered E4-based hormone therapy product candidate for the relief of vasomotor menopausal symptoms (VMS).
Liege, Belgium, 3 October 2019 – 7 :30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today provides supplementary details related to the US deal with Mayne Pharma for Estelle®.
- Remaining payment obligations to Uteron Pharma reduced by 62% to EUR 250 million
- otal payment duration reduced by twelve years
- Substantial reduction of total debt under IFRS
- Significant cash flow improvement safeguarding the development of Estelle® and Donesta®
- Option for Mithra to pay EUR 40 million cash tranche in equity
Liege, Belgium, 1 October 2019 – 13:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has reached an agreement in the form of a binding term-sheet with the former owners of Uteron Pharma relating to the remaining payment obligations that Mithra has under the current earnout agreement. Former owners of Uteron Pharma, which housed the asset E4 (synthesis and contraception) before divestment to Mithra, include an important number of shareholders.
- Historical agreement with Mayne Pharma, who became the second largest supplier of oral contraceptives in the US after the acquisition of a portfolio of branded generic products from TEVA in 2016
- Record deal value for Estelle®. Potential gross revenues in Mithra’s worst-case scenario at a minimum of EUR 4,5 billion, which represents more than twice the size of European deal
- Mithra eligible for license fees of at least USD 295 million
- Mithra to be awarded 9.6% equity stake across two tranches in Mayne Pharma
- CDMO cross fertilization opportunities for both companies
- Mithra grants exclusive license to Dexcel Pharma for commercialization of its two leading contraceptive products in Israel
- Dexcel Pharma is Israel’s largest private pharmaceutical company
- Production at the Mithra CDMO facility in Belgium
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