February 25, 2022
- CHMP opinion recommending approval based on data from the global Phase 3 HERO study
- If approved, ORGOVYX® would be the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe
- Company remains on track to reach agreement with a partner for international rights to relugolix in oncology by the anticipated European Commission approval
BASEL, Switzerland, Feb. 25, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormonesensitive prostate cancer. The European Commission (EC) will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
“This positive CHMP opinion represents another step toward positioning ORGOVYX® as a new standard of care for men with advanced prostate cancer,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to providing patients and physicians in Europe with the first oral, androgen deprivation therapy treatment to further advance our mission to redefine care for men with prostate cancer.”
The CHMP positive opinion recommending approval is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix compared to leuprolide in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX® received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with advanced prostate cancer in December 2020.
Myovant continues to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in prostate cancer. Myovant remains on track to reach an agreement with a partner by the anticipated EC approval of relugolix for advanced prostate cancer.
ABOUT PROSTATE CANCER
Prostate cancer is a leading cause of death in the European Union with about 65,200 men having died from the disease in 2016. The standardized death rate from prostate cancer stood at 38 deaths per 100,000 male inhabitants according to Eurostat.
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.
ABOUT MYOVANT SCIENCES
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively, as well as regulatory approvals by the European Commission and the Medicines and Healthcare products Regulatory Agency for women with symptomatic uterine fibroids. Additionally, Myovant has two regulatory submissions under review, a Marketing Authorization Application in advanced prostate cancer and a supplemental New Drug Application in endometriosis-associated pain. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of ORGOVYX®(relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The European Commission will review the CHMP recommendation. Myovant is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant is also developing MVT-602, an investigational 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 Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including: statements regarding Myovant’s aspiration to redefine care for women and for men; the expectations of commercialization and launch of ORGOVYX® for adultpatients with hormone sensitive advanced prostat cancer in Europe, if approved; the expectations of the European Commission’s review of the CHMP recommendation and the timeline of its final decision on the Marketing Authorization Application and the application of such decision in the European Union; Myovant’s expectations regarding partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in prostate cancer, including the timing of any potential agreement with a partner by the anticipated EC approval of relugolix for advanced hormone sensitive prostate cancer; and Myovant’s expectations regarding the potential benefits of ORGOVYX® and its potential to become the new standard of care androgen deprivation therapy for men with advanced hormone sensitive prostate cancer, if approved.
Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions, and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. Myovant Sciences cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could materially affect Myovant Sciences’ operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to, the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on January 26, 2022, as such risk factors may be amended, supplemented, or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for Myovant Sciences’ management to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.
Vice President, Investor Relations
Myovant Sciences, Inc.
+1 (650) 781-9106
Noelle Cloud Dugan
Vice President, Corporate Communications
Myovant Sciences, Inc.