Sumitovant Biopharma Has a Strong Fourth Quarter with Significant Clinical Development and Corporate Achievements Across its Portfolio of Companies

LONDON and NEW YORK, May 26, 2021 /PRNewswire/ -- Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant)  and Myovant Sciences (NYSE: MYOV), a publicly listed company that is majority owned by Sumitovant, achieved significant clinical and corporate milestones in the company's fourth quarter ending on March 31, 2021.

"We were delighted to see tremendous strides across the Sumitovant portfolio of companies in the fourth quarter including progress across clinical development, regulatory and commercialization milestones. Significant corporate accomplishments included Urovant transitioning from publicly traded to a wholly owned subsidiary of Sumitovant Biopharma and the appointment of executives in key roles for two of our subsidiary companies," said Myrtle Potter, CEO of Sumitovant Biopharma.  "In addition, progress was made in supporting health equity and access and formed collaborations to support educational and clinical initiatives.  This was an exciting quarter and I'm proud of what we've accomplished."

CLINICAL HIGHLIGHTS
Myovant Sciences (NYSE: MYOV), a majority-owned subsidiary
On March 29, the European Medicines Agency (EMA) validated Myovant Science's 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. If approved, relugolix would be the first and only oral androgen deprivation therapy for advanced prostate cancer in Europe.

On March 24, Myovant Sciences and its partner, Pfizer, announced positive data from Phase 3 LIBERTY randomized withdrawal study of once-daily relugolix combination therapy in women with uterine fibroids.

On February 17, Myovant Sciences and Pfizer announced publication in the New England Journal of Medicine of Phase 3 LIBERTY studies of once-daily relugolix combination therapy in women with uterine fibroids.

On January 26, Myovant Sciences and its partner, Pfizer, announced positive one-year data from its Phase 3 SPIRIT extension study of once-daily relugolix combination therapy in women with endometriosis

Urovant Sciences
On February 11, Urovant Sciences announced the continuation of a Phase 2a trial with URO-902, a novel gene therapy product in patients with overactive bladder and urinary incontinence following a positive recommendation from the study's Data and Safety Monitoring Board.

Altavant Sciences
On February 18, Altavant Sciences announced initiation of a chemical lung injury program in collaboration with BARDA and NIAID. The in vivo nonclinical proof-of-concept pilot study will evaluate ALTA-2350, a novel inhaled formulation of a recombinant IL-1Ra for the treatment of acute and chronic lung injuries 

Corporate Highlights
Myovant Sciences
On March 23, Myovant Sciences announced recipients of "Forward for Health Equity" grants to improve healthcare access in prostate cancer and uterine fibroids.

On February 16, Myovant Sciences and HealthyWomen, the nation's leading independent, nonprofit health information source for women, launched "Voices of Periods", an educational campaign to fight menstrual stigma.

On January 5, Myovant Sciences announced the U.S. availability of ORGOVYX™ (relugolix) for the treatment of advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.  More information about ORGOYYX, including the full product prescribing information, can be found here.

On January 4, Myovant Sciences announced the appointment of industry veteran David Marek as its new Chief Executive Officer and as a member of its board of directors. 

Urovant Sciences
On February 12, Urovant announced that the Urovant Board authorized and approved the definitive merger agreement in which Sumitovant Biopharma would acquire all outstanding shares of Urovant that are not held by Sumitovant Biopharma.

On March 23, Urovant shareholders voted to approve the definitive merger agreement with Sumitovant Biopharma by an affirmative vote of holders of a majority of Urovant's outstanding shares, and by holders of a majority of Urovant's outstanding shares that were not held by Sumitovant Biopharma.

On March 29, Urovant and Sumitovant Biopharma jointly announced the completion of the merger in which Sumitovant acquired all outstanding shares of Urovant. Urovant became a wholly owned subsidiary of Sumitovant Biopharma and Urovant's stock ceased trading on the Nasdaq stock market.

Spirovant Sciences
On January 26, Spirovant Sciences announced that the leasing of new and expanded headquarters and laboratories in Philadelphia's University City and that the company expanded its leadership team with the appointments of Eric Pastor as Senior Vice President of Technology Development and Operations and Maria Limberis, PhD, as Vice President of Research.

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 (NYSE: MYOV) and wholly owns Urovant, 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 was formed pursuant to 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. Altavant is currently developing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat is a tryptophan hydroxylase (TPH) inhibitor in Phase 2 development for patients with pulmonary arterial hypertension. By reducing serotonin production via TPH inhibition rodatristat may play a role in halting or reversing the vascular remodeling associated with PAH, offering a novel treatment option for patients living with this disease. ALTA-2530 is an inhaled interleukin-1 receptor antagonist under development for bronchiolitis obliterans syndrome (BOS), a life-threatening form of chronic lung allograft dysfunction (CLAD) that may present following lung transplantation. ALTA-2530's unique mechanism of action may offer a novel treatment option for patients who suffer from BOS, a disease where there are currently no approved therapies.

Altavant is a wholly owned subsidiary of Sumitovant Biopharma Ltd. For more information, please visit https://altavant.com. 

About Myovant Sciences 
Myovant Sciences (Myovant) aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. ORGOVYX™ (relugolix) was approved by the FDA in 2020 as the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix is also under regulatory review in Europe for men 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 the U.S. and Europe for women with uterine fibroids, has completed Phase 3 registration-enabling studies for women with endometriosis, and is being assessed for contraceptive efficacy in healthy women ages 18-35 years who are at risk for pregnancy. 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 Spirovant Sciences, Inc.
Spirovant is a gene therapy company focused on changing the course of cystic fibrosis and other respiratory diseases. The company's current investigational gene therapy technologies are designed to overcome the historical barriers that have prevented effective genetic treatments for cystic fibrosis. Spirovant's lead programs are in development for cystic fibrosis. Spirovant is a wholly owned subsidiary of Sumitovant Biopharma Ltd., which is itself a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd.  Spirovant is located in Philadelphia, PA. More information is available at https://www.spirovant.com/.

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 Sumitovant Biopharma 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.

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.

SOURCE Sumitovant Biopharma

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