Mithra receives Orphan Drug Designation from FDA for E4 in neonatal encephalopathy treatment

  • 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 Signs Partnership Agreement With Itrom for Commercialization of Estelle® in the Middle East

  • 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).

Mithra Announces Positive Top-line Results of Estelle® Phase III Oral Contraceptive Study in U.S/Canada

  • 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.

 

Blockbuster Potential in Perimenopause with new E4 Candidate and Acceleration of Donesta Phase III Program

  • 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.

Mithra Announces Positive Results of Ovarian Function Sub-Study which Strengthens Estelle® Contraceptive Efficacy Profile

  • 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®.

 

 

Full Estetrol (E4) Program Update Provided at Scientific Advisory Board Meetings

  • 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
Liège, Belgium, 19 November 2018 – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces that it held two scientific advisory board (SAB) meetings in New Orleans (LA) at the end of October to discuss the progress in the development plans for Estelle® and Donesta®, Mithra’s key programs for contraception and menopause. The SABs, composed of American and Canadian experts in these fields, provided constructive feedback on the recently completed EU/Russia phase III trials for Estelle®. Guidance on the phase III clinical development plan for Donesta®, Mithra’s next generation hormonal therapy, was also received.

Mithra Announces the Completion of its Lead Clinical Phase III Programme for Estelle®

  • 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.

Mithra Signs Exclusive License and Supply Agreement with Adcock Ingram for Commercialization of Estelle® in Southern Africa

  • Mithra is eligible for a downpayment of EUR 1.5 million
  • 20-year exclusive license and supply agreement to generate annual recurring revenues and royalty payments
  • Production at the Mithra CDMO facility
  • Deal forms part of Mithra’s strategy to realise the full potential of the pipeline programs through global partnerships with leaders in Women’s Health

Liège, Belgium, 30 October 2018 – Mithra (Euronext Brussels: MITRA) today announced that it has entered into an exclusive license and supply agreement with Adcock Ingram to commercialize Estelle®, a combined oral contraceptive (COC), containing 15 mg Estetrol (E4) / 3 mg drospirenone (DRSP), in Southern Africa1. The product is a novel combined oral contraceptive with natural, native estrogen acting selectively in tissues combined with DRSP’s non-contraceptive benefits.

Presentation of Donesta® PhIIb Results at the 2018 Annual Meeting of the North American Menopause Society

Liège, Belgium, October 3nd 2018 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, today announces its Phase IIb results for Donesta® will be presented at the 29th Annual Meeting of the North American Menopause Society (NAMS), being held on 3-6 October 2018 in San Diego, CA.

 

Mithra Finalizes Contract for the Commercialization of Estelle® with South Korean Women’s Health Leader Hyundai Pharm

Liège, Belgium, 24 September 2018 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is pleased to announce the finalization and signature of the contract with Hyundai Pharm, a South Korean Women’s Health leader, for an exclusive license and supply agreement to commercialize Estelle® in South Korea. The signature follows the binding Heads of Terms agreement previously announced on 5 June 2018.