- 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
- Estelle®, Mithra’s oral contraceptive product candidate, has been granted a key patent for the dysmenorrhea indication in Japan, a four times larger market than the contraceptive one.
- Important milestone for the commercialization of Estelle® by Fuji Pharma in Japan and ASEAN, representing a total attractively priced market of EUR 400 million annual sales.
- Thanks to a solid Intellectual Property strategy, Estelle® will be protected from any generic competitor on the Japanese market until 2037 with a potential patent term extension of a maximum of 5 years.
Liege, Belgium, 08 August 2019 – 7 :30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has received an additional patent for Estelle® in Japan in the dysmenorrhea indication. Estelle® is Mithra’s combined oral contraceptive (COC) candidate, composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).
- Strengthening of management team with key appointments of Chief Scientific Officer and Plant Manager, to support the strategy execution of Mithra CDMO
- Consolidation of R&D and manufacturing teams with 30% increase in highly qualified staff since the beginning of the year
- Donesta® and PeriNesta® Phase III studies ready to begin, pending approval by authorities
- Launch of production of Estelle® clinical validation batches for both U.S. and EU filing
- Positive outcome of the registration procedure for Myring™, adding 15 new Market Authorizations in Europe
- The US Food and Drug Administration granted E4 an ODD for the treatment of life-threatening hypoxic ischemic encephalopathy (HIE)
- This new designation expands E4’s broad potential in therapeutic areas beyond the leading indications in women’s health
- Mithra continues its preclinical studies in HIE, a severe pediatric syndrome that affects 30,000 newborns each year in Europe and the United States
Liege, Belgium, 2 April 2019 – 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has received Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for the use of E4 in Neonatal Encephalopathy (NE). In addition to its three late-stage E4-based product candidates for contraception, perimenopause and menopause, Mithra is developing E4’s potential in other therapeutic areas, particularly in neuroprotection for the treatment of hypoxic ischemic encephalopathy (HIE), a life-threatening form of neonatal asphyxia.
- Mithra strengthens its presence in the Middle East with a third partnership with UAE-based ITROM Pharmaceutical Group for the combined oral contraceptive Estelle®
- Following the publication of the positive top-line results of the Estelle® Phase III study, Mithra is intensifying its business development strategy of its potential contraceptive blockbuster in key international markets
- Agreement follows licensing deals for Estelle® with market leaders in Europe, Russia, Canada, Brazil, Japan, South Africa and South Korea
Liege, Belgium, 28 February 2019 – 7 :30 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces that it has signed a 20-year binding Head of Terms agreement with ITROM Pharmaceutical Group (ITROM) for the commercialization of Estelle® in the Middle East. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate, containing 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).
- Primary efficacy endpoint indicates excellent contraceptive efficacy, with a Pearl Index (PI) of 2.41 per 100 women, in line with expectations
- Key secondary endpoints achieved, including excellent bleeding profile, cycle control, quality of life and safety and tolerability
- Data in line with previously announced Phase III trial in EU / Russia confirming Estelle’s®outstanding profile as a novel, next-generation combined oral contraceptive
- Filing with U.S. and EU regulatory agencies anticipated by year end
Liège, Belgium, 30 January 2019, 07:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced that its Phase III Estelle® study conducted in the United States and Canada successfully met its primary efficacy endpoint.
Efficacy is well in line with expectations, similar to a recently FDA approved combined hormonal contraceptive (Annovera™ PI 2.98 [95% Confidence Interval 2.13-4.06]) per 100 woman-years of use) and to Lo-Loestrin® (PI 2.92 [95% Confidence Interval 1.94-4.21]), one of the best-selling Combined Oral Contraceptives (COC) in the United States with USD 527.7 million sales in 2018 (15% yoy growth). Estelle® is Mithra’s COC candidate, composed of Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.
- Potential for new perimenopause product candidate PeriNesta launch as early as 2023, with an estimated market opportunity of at least 18 million patients annually in the US and key EU markets
- Donesta® phase III E4 monotherapy patient recruitment anticipated to start in Q3 2019 pending approvals , potential market authorisation by end 2023
- Ongoing global patent filings could protect Donesta® and PeriNesta IP estate until 2039
Liège, Belgium, 07 January 2019 – 6:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the further expansion of its Estetrol (E4)-based programs with a decision to target the underserved perimenopausal market, which affects women between reproductive age and post-menopausal age. The Company believes this additional indication for a product with a comparable formulation to E4 15mg/DRSP 3mg represents a major new market opportunity that requires only limited additional investment.
The Company also announced plans to accelerate preparations for its proposed Phase III E4 monotherapy study of Donesta® in menopause. Mithra has appointed leading specialist Contract Research Organization (CRO) ICON Plc (NASDAQ: ILCR) to manage the study and recruitment is expected to begin in the second half of 2019, pending approvals.
- Effective ovulation inhibition with no single ovulation at cycles 1 and 3
- Data further strengthens the contraceptive efficacy profile of Estelle® previously shown in top-line EU/Russia phase III study results
- Results further support Estelle® as a novel, next-generation combined oral contraceptive for women
Liège, Belgium, 6 December 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announced positive results from its ovarian function sub-study for Estelle®, Mithra’s combined oral contraceptive (COC) candidate composed of 15mg Estetrol (E4) and 3mg drospirenone (DRSP). The study forms part of the broader development plan to demonstrate the overall contraceptive efficacy of Estelle®.
- Scientific Advisory Boards consulted for the next stages of development and regulatory approval of Estelle® and Donesta® – Mithra’s late stage contraceptive and menopause candidates
- Completion of Estelle® Phase III US/Canada study of Estelle® phase III programme completes
Mithra’s most advanced clinical programme
- EU/Russia study reported positive results achieving primary and secondary endpoints
- Estelle® Phase III study in US/Canada will report top-line results in Q1 2019
- Estelle® : a step closer to become next generation COC on the market
Liège, Belgium, 14 November 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces the completion of the Phase III Estelle® study in the US and Canada. Estelle® is Mithra’s novel combined oral contraceptive (COC), containing 15 mg Estetrol (E4)/3 mg drospirenone (DRSP). Top line data remain on track to be reported in Q1 2019.
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