Sumitovant Biopharma’s Portfolio of Innovative Companies Achieve Significant Clinical and Corporate Milestones in its Third Quarter of Operation

-- Third quarter achievements include two FDA approvals and commercialization agreements in prostate cancer and women’s health

LONDON and NEW YORK, March 02, 2021 (GLOBE NEWSWIRE) -- — Sumitovant Biopharma. today announced that its five subsidiary healthcare companies (Myovant, Urovant, Enzyvant, Altavant and Spirovant ) achieved multiple clinical and corporate milestones in the company’s third quarter ending on December 31, 2020.

“The Sumitovant family of companies continue to advance our pipeline with two FDA approvals, a global commercialization and development collaboration, clinical progress and recognition for one of our CEOs as a visionary company leader,” said Myrtle Potter, CEO of Sumitovant Biopharma. “We are pleased to see so much progress in Sumitovant’s third quarter of operation.”

Regulatory and Clinical Highlights

On December 18, 2020, the FDA approved Myovant’s ORGOVYX^TM(relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX is the US first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for advanced prostate cancer.

On December 23, 2020, the FDA approved Urovant’s GEMTESA® (vibegron) for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.

On November 24, 2020, Urovant Sciences announced topline data from its Phase 2a study of vibegron for the treatment of irritable bowel syndrome (IBS) pain that did not meet its primary endpoint.

On October 21, 2020, Myovant presented additional data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in endometriosis and uterine fibroids at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress.

Corporate Highlights

On December 28, 2020, Myovant announced a collaboration with Pfizer in the US and Canada in women’s health plus an option for ex-US minus certain Asian countries in prostate cancer. The companies will jointly develop and commercialize ORGOVYX in advanced prostate cancer and relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health including uterine fibroids and endometriosis.

On November 12, 2020, Sumitovant Biopharma and Urovant Sciences announced Sumitovant’s planned acquisition of the remaining stake in Urovant Sciences that it does not currently own.

On October 13, 2020, Spirovant CEO Joan Lau was named Entrepreneur of the Year in Greater Philadelphia by Ernst & Young.

On October 7 2020, Spirovant CEO Joan Lau was named a Woman of Distinction by the Philadelphia Business Journal.

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 Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Myovant has one FDA-approved medicine, ORGOVYX for adult patients with advanced prostate cancer. Urovant has one FDA-approved medicine, GEMTESA 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence. 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. Follow Sumitovant on LinkedIn.

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 redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Myovant has one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Myovant’s lead product candidate, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg), is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Myovant is 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 Myovant’s majority shareholder. For more information, please visit Myovant’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The Company’s lead product, GEMTESA (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH). The Company’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a subsidiary of Sumitomo Dainippon Pharma Co., Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

Forward-Looking Statements
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.

For more information with respect to Myovant Sciences, including disclosure regarding the risks and uncertainties related to any forward-looking statements, please refer to 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 February 10, 2020, as such risk factors may be amended, supplemented or superseded from time to time.

For more information with respect to Urovant Sciences, including disclosure regarding risks and uncertainties related to any forward-looking statements, please refer to Urovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings with the SEC. Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

This press release contains “forward-looking statements” concerning the development and commercialization of Altavant’s products, the company’s business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Altavant undertakes no obligation to update any forward-looking statements for any reason.

CONTACT: Mary Stutts Sumitovant Biopharma 707-373-0097 mary.stutts@sumitovant.com