Benzinga | Mar 29, 2021 06:59AM EDT

Myovant Sciences Announces European Medicines Agency Has Validated Its Marketing Authorization Application For Relugolix for the Treatment of Advanced Prostate Cancer

Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.

"We are delighted that the Marketing Authorization Application for relugolix has been accepted for review by the European Medicines Agency. This is an important milestone in bringing a potential oral treatment option to men with advanced prostate cancer in Europe," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "Following our recent FDA approval and launch in the U.S., we believe relugolix has the potential to transform the standard of care for men with advanced prostate cancer requiring androgen deprivation therapy. We look forward to making this potential treatment available to more men around the world."

Under the terms of the collaboration between Myovant and Pfizer to develop and commercialize relugolix, Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries. If Pfizer exercises this option, Myovant will receive $50 million and be eligible to receive double-digit royalties on net sales from these markets. Pfizer's decision to exercise this option is expected in the first half of calendar year 2021.

The MAA is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study evaluating the safety and efficacy of relugolix in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Relugolix received U.S. Food and Drug Administration (FDA) approval in December 2020.