Sumitovant Biopharma's Family of Companies Achieve Multiple Clinical and Corporate Milestones in the First Full Quarter of Sumitovant's Operation

LONDON and NEW YORK, May 21, 2020 /PRNewswire/ -- Sumitovant Biopharma, Inc. today announced that members of its family of five healthcare companies achieved multiple clinical and corporate milestones in the company's first quarter of operation.

"The Sumitovant family of companies continue to advance our pipeline with positive clinical trial results, multiple regulatory submissions, publication of data in major medical journals, an acquisition and a global commercialization agreement," said Myrtle Potter, CEO of Sumitovant Biopharma. "As a new company, we are pleased that our first quarter of operation has yielded progress on so many potential therapies for patients."

Clinical Highlights
On February 4^th, Urovant Sciences announced the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder (OAB) from two double-blind, placebo-controlled randomized Phase 1 trials. The first trial was conducted with instillation therapy and the second trial with direct injections into the bladder wall under local anesthesia. The peer-reviewed publication was published online in Neurology and Urodynamics. 

On February 10^th, Myovant Sciences announced that the Phase 3 LIBERTY open-label extension study of once-daily, oral relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) demonstrated an 87.7% response rate at one year while maintaining bone mineral density. 

On March 2^nd, Urovant Sciences announced the publication of the efficacy and safety results of vibegron in patients with overactive bladder (OAB) from the international Phase 3 EMPOWUR trial. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the August issue of Journal of Urology.

On March 5^th, Urovant Sciences announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

On March 9^th, Myovant Sciences announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with moderate to severe symptoms associated with uterine fibroids. The two most common symptoms associated with uterine fibroids are heavy menstrual bleeding and pain.

Corporate Highlights
On January 8^th, Altavant Sciences announced it had entered into a definitive agreement to acquire Onspira Therapeutics, a private drug development company similarly focused on therapeutics for rare pulmonary diseases. This acquisition expands Altavant's pipeline to include OSP-101, a novel inhaled interleukin-1 receptor antagonist (IL-1Ra) with orphan drug designation from the U.S. Food and Drug Administration. OSP-101 is in preclinical development for the treatment of bronchiolitis obliterans syndrome (BOS), the leading non-infectious complication following lung transplantation and a major cause of death in these patients.

On March 31^st, Myovant Sciences and Gedeon Richter Plc., a major pharmaceutical company in Central Eastern Europe focused on women's health, announced that they have entered into an exclusive license agreement for Gedeon Richter to commercialize relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the agreement, Myovant will receive an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones and $107.5 million in sales-related milestones, and tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S., as well as rights to relugolix in other therapeutic areas outside of women's health. 

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. 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 Altavant Sciences
Altavant Sciences is a clinical-stage biopharmaceutical company focused on elevating patient-centric drug development in rare respiratory diseases with an initial focus on pulmonary arterial hypertension (PAH). Altavant's lead candidate for PAH, rodatristat ethyl, is a prodrug for rodatristat, a tryptophan hydroxylase (TPH) inhibitor that has achieved reductions in peripheral production of serotonin in healthy subjects, and may lower circulating serotonin levels in diseases where excessive production of the hormone has been implicated in their pathogenesis – including PAH, certain types of cancer, GI disorders, fibrosis and inflammation. Rodatristat ethyl is currently being evaluated in the ELEVATE 1 Phase 2 study for patients with PAH. Altavant became a wholly owned subsidiary of Sumitovant Biopharma Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. in December 2019 through a strategic alliance between Sumitomo Dainippon Pharma and Roivant Sciences Ltd. (Headquarters: Basel, London, UK). For more information, please visit www.altavant.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.

About Urovant Sciences
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The company's lead product candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder (OAB). Urovant Sciences reported positive data from the vibegron 12-week, Phase 3 pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. The Company submitted a New Drug Application to the FDA seeking approval of vibegron for the treatment of patients with OAB in December 2019. Vibegron is also being evaluated for treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS). Urovant'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 Sumitovant Biopharma Ltd., which is a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about Urovant 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.

Media Contacts:

Sumitovant Biopharma
Mary Stutts
SVP, Corporate Relations
[email protected]

Myovant Investor Contact:
Frank Karbe
President, Chief Financial Officer
Myovant Sciences, Inc.
[email protected]

Myovant Media Contact:
Albert Liao 
Director, Corporate Communications
Myovant Sciences, Inc.
[email protected]

Urovant Investor Contact:
Ryan Kubota
[email protected]

Urovant Media Contact:
[email protected]

SOURCE Sumitovant Biopharma

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