Mithra and Richter Sign License and Supply Agreement for Commercialization of Estelle®, a Novel Oral Contraceptive

Liège, Belgium – 12 September 2018, 7:30 CEST – Mithra Pharmaceuticals (hereinafter: “Mithra”) and Gedeon Richter Plc. (hereinafter: “Richter”) today announced that they have entered into a license and supply agreement to commercialize Estelle®, a combined oral contraceptive (COC), containing 15 mg Estetrol (E4) / 3 mg drospirenone (DRSP), in Europe and Russia. Richter will commercialize the product under a different brand name. The product is a novel combined oral contraceptive with natural, native estrogen acting selectively in tissues combined with drospirenone’s non-contraceptive benefits.

Under the terms of the agreement Richter will make, upon signature of the contract, an upfront payment totaling EUR 35 million. Additional milestone payments amounting to EUR 20 million will be made depending on the progress of the regulatory process of the product. Further sales-related royalties will be payable to Mithra subsequent to the launch of the product. Moreover, Mithra will receive guaranteed annual recurring revenues based on minimum annual quantities (MAQ), in addition to tiered royalties on net sales.

François Fornieri, CEO of Mithra Women’s Health commented : “We are very pleased to have agreed terms with Richter for the commercialization of our next generation oral contraceptive product candidate Estelle® in Europe and Russia. This is by far the biggest contract in Mithra’s history. As an undisputed leader in Women’s Health, with a rapidly expanding direct presence in Western Europe, we are confident that Richter is the best possible partner for Estelle® in this important geography. We are looking forward to a fruitful and long-term collaboration with the Richter team. Today’s news further reinforces our confidence in our ability to sign a future partnership for Estelle® in the US, where the oral contraceptive market is valued at twice the size of the European market.”

Gábor Orbán, CEO of Gedeon Richter Plc, added : “Broadening our core Women’s Healthcare portfolio remains a paramount objective of Richter’s strategy aiming towards the improvement of the quality of life of the female population in all age groups. This agreement fits into this endeavour and we look forward to a successful cooperation with Mithra in the commercialization of a novel oral contraceptive.”