Mithra and Searchlight Pharma announced that Health Canada has approved Nextstellis, the first and only combined oral contraceptive (COC) product based on the unique native estrogen estetrol (E4). Once launched, E4 will be the first new estrogen in a COC in the Canadian market in over half a century, and will be the only COC alternative to ethinyl estradiol-based COC pills in Canada. Developed by Mithra, Nextstellis is composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP) in a 24/4 dosing regimen. E4 is a naturally occurring native estrogen produced in the human body, with a unique mechanism of action that displays tissue selective activity. E4 shows agonist activity on the vagina, the uterus and the endometrium, the bones and the brain, and antagonistic activities in breast tissue. Neutral impact on lipids and a distinct metabolic and hemostatic profile provide further differentiation based on its unique mechanism of action. E4 is synthesized from plant-based sources and represents the first native estrogen available in any contraceptive product in Canada. Health Canada's approval of Nextstellis is based on two multinational, multicentre Phase 3 clinical studies of 3,725 women who were 16 to 50 years of age, and who had a Body Mass Index (BMI) up to 35kg/m2. Nextstellis demonstrated contraceptive efficacy across all evaluated age and BMI ranges. The studies also demonstrated good bleeding profiles, cycle control, and tolerability, and with low rates of adverse reactions. The approval in Canada is the first marketing authorization for Nextstellis in any jurisdiction, anywhere in the world. Regulatory reviews remain ongoing in the United States and European Union, with expected marketing authorizations in H1 2021. Currently, the Canadian hormonal contraceptive market is worth approximately CAD 348 million a year, with combined oral contraceptives accounting for about 66% of the market. Nextstellis will complement and deepen Searchlight Pharma's industry-leading women's health product portfolio which includes Addyi (flibanserin), a first-in-class medication in Canada for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in both pre and post-menopausal women up to age 60, as well as market-leading brands such as Mona Lisa IUDs for contraception, and menopausal treatments such as Divigel and Estragyn Vaginal Cream.