Company Myovant Sciences and Gedeon Richter announced the conclusion of an exclusive license agreement to market the combination drug relpax (relpax 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg) for the treatment of uterine fibroids and endometriosis in Europe and the CIS, and also in Russia, Latin America, Australia and New Zealand.
The agreement provides that Myovant will receive an advance payment in the amount of $ 40 million and the right to milestone payments totaling up to $ 40 million to resolve regulatory issues and 107,5 million dollars for the decision of questions on sales and license fees from net profit after the approval of regulatory authorities. Myovant reserves all the rights for a combination drug relpax in the United States, as well as the rights to the drug in other therapeutic areas that are not related to women’s health.
Under the terms of the agreement, Myovant will continue to engage in international development of a combined drug relpax. Gedeon Richter will be responsible for clinical development at the local level, production and promotion in their markets. Myovant also provided Gedeon Richter the opportunity to collaborate in the further development of new indications combination drug relpax in all areas of women’s health and fertility.
In March 2020 Myovant filed an application for registration to the European medicines Agency (EMA) combined drug relpax to treat women with symptoms of uterine fibroids moderate and severe. The application was accepted and is currently pending EMA. In the second quarter of 2020 Myovant awaiting the main results of the phase III studies, the SPIRIT 2 and SPIRIT to 1, which was conducted among women with pain related to endometriosis.