Mithra Announces Publication of Estelle® Abstracts in Connection with the 13th Annual Meeting of the European Society of Gynecology

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.

Presentation of Estelle® Phase III results at the 13th Meeting of the European Society of Gynecology

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.

Mithra Initiates Phase III Clinical Program for Donesta®

  • 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).

Mithra Provides Supplementary Details on Estelle® US Deal with Mayne

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®.

Mithra Sucessfully Renegotiates Earnout Payments

  • 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.

Mithra Signs Landmark Contract for Estelle® in the United States with Mayne Pharma

  • 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
Liege, Belgium, 01 October 2019 – 13:00 CEST – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, is very pleased to announce that it has signed a License and Supply Agreement (LSA) with Mayne Pharma Group Limited (hereinafter referred to as “Mayne”), a leading Women’s Health player in oral contraceptives in the United States (US), for an exclusive license to commercialize Estelle® in the US. Estelle® is Mithra’s novel combined oral contraceptive (COC) product candidate based on Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile. E4 is a native estrogen produced by the human foetal liver during pregnancy. Following more than 20 years of research and development, Mithra can now produce E4 at scale through a complex plant-based (soja) production synthesis process.

Mithra Signs LSA for Commercialization of Estelle® and Myring™ in Israel

  • 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
Liege, Belgium, 20 August 2019 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that it has entered into two exclusive license and supply agreements with Dexcel Pharma for the commercialization in Israel of two major products in contraception:  the combined oral pill Estelle® and the hormonal ring Myring™.

Mithra obtains crucial additional Estelle® patent in Japan

  • 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).

Mithra CDMO Strengthens its Management Team and Accelerates Key R&D Programs

  • 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
Liege, Belgium, 16 July 2019 – 7 :30  CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces it has strengthened its CDMO Management team with the appointments of Dr Graham Dixon as Chief Scientific Officer and Mr Renaat Baes as Plant Manager.

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.