Mithra, a company specialized in women's health, has announced that the Australian Patent Office, IP Australia, has granted patents covering the synthesis process of Estetrol (E4). IP Australia has also accepted a patent application for a patent covering E4 alone as an emergency contraceptive. E4, a naturally ocurring estrogen, is currently being studied in the E4 Freedom Phase III study programme in contraception (Estelle, 15 mg E4/3 mg drospirenone) and in the E4 Relief Phase II trial for menopause (Donesta, dose-finding study with E4 alone).
The synthesis patents, which run until 2032, is an essential IP layer to extend existing patent families and protect the production know-how of Mithra's E4-based product candidates. The synthesis process, which optimizes and reduces the costs of manufacturing E4, was developed in exclusive partnership with PCAS (France), a leading manufacturer of complex molecules. The patent follows similar patents granted in territories including Europe, Eurasia and Hong Kong.
The additional emergency contraception patent, when granted, will specifically cover E4 as a potential new emergency contraception option where E4 is used alone. This new method differs from currently approved emergency contraceptives which include progestin-only pills and combined estrogen-progestin pills. E4's potentially improved safety profile when compared to currently marketed estrogens, could provide an attractive alternative to emergency contraceptive options available to women today. E4's use as an emergency contraception is supported by its specific and unique mode of action wherein E4 activates the nuclear estrogen receptor but blocks the membrane estrogen receptor. Research suggests that inhibition of the membrane estrogen receptor plays a key role in suppressing ovulation.
François Fornieri, chief executive officer of Mithra, commented: "We are pleased with the IP progress made in Australia, both with regard to the synthesis of E4 as well as for E4's development in emergency oral contraceptive applications. Given its unique mode of action, E4 has the potential to revolutionize the contraceptive and menopause market, offering a potentially improved safety profile compared to the current generation of estrogens, and we consider Australia an important additional market for these indications."
Mithra pharma, australian patent, synthesis process of estetrol
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