Wednesday November 25th 2020

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Mithra, a company dedicated to Women’s Health, announces that the European Medicines Agency (EMA) has designated Estetrol monohydrate (E4) as a New Active Substance (NAS) in its "Day 180" report, concluding the second phase of the ongoing evaluation of Estelle® birth control pills for the European market.

The countless potential applications of Estetrol in health care have been at the heart of Mithra's research for nearly 20 years. Estetrol (E4) is a naturally occurring hormone produced by the human fetus during pregnancy. Through a complex production process, Mithra has succeeded in reproducing E4 and developing a platform of innovative products dedicated to women's health. This research has notably led to the development of the product candidates Estelle®, a new era in combined oral contraception, and Donesta®, a new generation hormonal treatment for vasomotor symptoms of menopause.

For Mithra, this finding illustrates the profoundly innovative nature of the results of its research on E4: it is indeed the first time in more than 80 years that a new active substance, a new estrogen in this case, is appearing in the field of contraceptive solutions.

François Fornieri, Chief Executive Officer of Mithra Women’s Health : " After having already been awarded last year with the "essenscia Innovation Award" for the major breakthrough and global potential of the new generation contraceptive pill Estelle®, Mithra is now realizing the results of its many years of research recognized by the competent authorities. The potential for exploiting the health benefits of Estetrol is all the more important.”