Hungary's Richter adds new product to gynaecological portfolio

Richter and Myovant Sciences GmbH, a healthcare company focused on developing innovative treatments for women's health and prostate cancer, today announced that they have entered into an exclusive license agreement for Richter to commercialize relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia and New Zealand.

Under the agreement, Myovant will receive an upfront payment of USD 40 million and is eligible to receive up to USD 40 mn in regulatory milestones and USD 107.5 mn in sales-related milestones, plus tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S., as well as rights to relugolix in other therapeutic areas outside of women’s health.

Under the terms of the agreement, Myovant will continue to lead the global development of relugolix combination tablet. Richter will be responsible for local clinical development, manufacturing, and all commercialization for its territories. Myovant has also granted Richter an option to collaborate on relugolix combination tablet for future indications in women’s health other than fertility.

Adding innovative products to our core women’s healthcare portfolio has been the focus of our strategy. Through this license agreement with Myovant, we have a unique opportunity to make a meaningful difference in the lives of millions of women suffering from uterine fibroids and endometriosis,

Richter Chairman Erik Bogsch said.

"We are delighted to be joining forces with Richter, a company with a leading market position in women’s health in more than 38 countries, to accelerate the potential global launch of one pill, once a day relugolix combination tablet for women with uterine fibroids and endometriosis," said Frank Karbe, President and CFO of Myovant. "In addition, this agreement further strengthens Myovant’s financial position and focus as we continue to advance the development of relugolix and prepare for multiple potential upcoming launches in the U.S."

Myovant submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids in March 2020. The application has completed validation and is now under evaluation by the EMA. Myovant expects top-line data from the Phase III SPIRIT 2 and SPIRIT 1 studies in women with pain associated with endometriosis in April and the second quarter of 2020, respectively.