Monday October 19th 2020


Mithra, a company dedicated to Women’s Health, announces that it has entered into an exclusive license and supply agreement with Gynebio Pharma for the commercialization of Estelle® in North Africa. Estelle® is a novel, next generation oral contraceptive product candidate containing Estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg, with a unique benefit/risk profile.

Based in Casablanca, GyneBio Pharma is a leading Women’s Health company in North Africa. It commercializes the most sold contraceptive pill in Morocco and has just commissioned the first hormonal plant in Morocco. Gynebio Pharma partners with top International players to market Women’s Health products in North Africa and also offers best-in-class hormonal production services.

Under the terms of this 20-year agreement, Gynebio Pharma will distribute Estelle® in Algeria, Morocco and Tunisia, where Estelle’s® benchmark market (EE/DRSP) is rapidly growing and worth approximately EUR 5.7 million per year1 . Mithra will receive an upfront payment and will be eligible to receive milestone payments, sales-related milestones and recurring revenues based on minimal annual quantities (MAQ). This agreement represents a deal worth up to EUR 25 million over the period for Mithra.

The agreement with GyneBio Pharma follows a number of licensing deals for Estelle® with key commercial partners in the United States, Europe, Russia, Canada, Australia, Brazil, Japan/ASEAN, South Korea, Hong-Kong, Taiwan, South Africa, Israel, Middle East and North Africa.

François Fornieri, CEO Mithra Women’s Health, commented: “We are pleased to have finalized the agreement with GyneBio Pharma for the commercialization of our contraceptive Estelle® in North Africa. Following the landmark deal signed with Mayne Pharma for the United States and recently for Australia, we continue to extend Estelle's licenses with best-in-class partners to maximize the potential of our innovative product in core territories. Filing of Estelle® has already been accepted by both US and European regulatory agencies, and we are currently manufacturing the safety stock ordered by our partners. In parallel, we are working in tandem with our partners on the commercial roll-out strategy of Estelle®, in order to be ready for commercialization, which is expected in the first half of 2021".

Abdelhakim Tahri, CEO Gynebio Pharma, commented: “We are very proud to bring Estelle®, the new era in contraception, to North African women and we are happy to collaborate with Mithra. Through this new partnership, Gynebio confirms once again its ambition to improve the quality of life of female patients by providing best-in-class products”.