E4 Paves the Road Towards a Revolutionary Era of Environmental Friendly Medicines

• 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

Liege, Belgium, 10 January 2020 – 7:30  CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that data from a recent environmental assessment study shows that Estetrol (E4) is significantly more environmentally-friendly compared to alternatives currently on the market

Steroidal estrogens, either naturally occurring in the human body, or produced synthetically, belong to a group of worldwide consumed substances with pharmaceutical and veterinary uses. They commonly occur in aquatic ecosystems as a result of estrogen added to livestock feeding or discharge from wastewater treatment plants after human exposure to COCs or treatments of menopause.

The profile of E4 is unique and safer with a different potency than the synthetic estrogen Ethinylestradiol (EE2) present in 97% of COCs. EE2 is a synthetic estrogen, designed to be resistant to degradation and inactivation. It was intended to have comparable biological activities as E2, but more persistent due to its stability in the human body. Because of these properties, EE2 persists longer and accumulates more in the environment than natural estrogens.

Steroidal estrogens present in environmental waters may interact with the functioning of the endocrine system. In situations where exposure is unwanted or unintentional, they may be considered as endocrine disrupting chemicals (EDCs) that lead to epigenetic and transgenerational effects. EE2 is considered to be a strong environmental endocrine disruptor which accumulates in living organisms impacting ecosystems. It is found in over 97 % of COCs. Over 700 kg¹ of EE2 are discharged every year in the waters based solely from birth pill control intakes. EE2 can disrupt sexual differentiation and alter adult behaviours in various aquatic species.