Sumitovant Biopharma Reports Key Clinical and Regulatory Milestones by Myovant Sciences
- Myovant Sciences submits New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer.
- Myovant announces positive results from Phase 3 SPIRIT 2 study evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and from a separate ovulation inhibition study.
- Myovant expects to submit an NDA for once-daily relugolix combination therapy for treatment of women with uterine fibroids in May 2020.
“We are pleased with Myovant’s progress developing once-daily, oral relugolix monotherapy and relugolix combination therapy,” said Myrtle Potter, CEO of Sumitovant Biopharma, a wholly-owned subsidiary of Sumitomo Dainippon Pharma. “Myovant’s mission to redefine care for women’s health and prostate cancer aligns with Sumitovant’s goal to make a difference in the lives of people globally by rapidly developing innovative medicines with our technology-enabled approach to drug development and commercialization. In doing so we believe we have the potential to become a core growth engine for our parent company, Sumitomo Dainippon Pharma.”
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. For further information about Sumitovant, please visit https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.
About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. The company’s lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis, and prostate cancer. The company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has completed a Phase 2a study for the treatment of female infertility as part of assisted reproduction. Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited, the originator of relugolix, previously granted the company a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive license to develop and commercialize MVT-602 in all countries worldwide. Sumitovant Biopharma Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is the majority shareholder of Myovant. For more information, please visit the company’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
This press release contains forward-looking statements that are based on management’s assumptions and beliefs in light of information available up to the day of announcement and thus involve both known and unknown risks and uncertainties. Actual financial results and other situations of the future may differ materially from those presented in this press release due to various factors.
SVP, Corporate Relations
Director, Corporate Communications
Myovant Sciences, Inc.
President, Chief Financial Officer
Myovant Sciences, Inc.