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Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer | Small Molecules

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Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer

  • If approved, relugolix would be the first and only oral androgen deprivation therapy for advanced prostate cancer in Europe
  • Relugolix is FDA-approved and currently available in the U.S. under the trade name ORGOVYX™
  • Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, with a decision expected in the first half of 2021

BASEL, Switzerland I March 29, 2021 I 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.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 250,000 men are estimated to be newly diagnosed in 2021.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 300,000 men are treated with androgen deprivation therapy each year in the U.S.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We have one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Our lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5mg), is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

SOURCE: Myovant Sciences

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