Urovant Sciences Announces Publication of Positive Long-Term Clinical Safety and Efficacy Data on the FDA-Approved Overactive Bladder Therapy, GEMTESA® (vibegron), in the Journal of Urology

EMPOWUR extension study demonstrates favorable results in long-term treatment of overactive bladder with GEMTESA, including favorable tolerability and improvements in incontinence efficacy endpoints

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences, a wholly owned subsidiary of Sumitovant, announced today that the Journal of Urology has published positive safety and efficacy data from the GEMTESA® (vibegron) double-blind 40-week extension study with patient data over a total exposure of 52 weeks (NCT03583372) in the print version of the Journal of Urology. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the May issue of the journal.

The published analysis supports the safety and efficacy of GEMTESA for the treatment of overactive bladder (OAB) in patients with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.

GEMTESA, a once-daily, beta-3 adrenergic agonist, received U.S. Food and Drug Administration approval in December 2020 for the treatment of OAB. Over the total exposure of 52 weeks, starting with the 12-week placebo-controlled phase 3 EMPOWUR study and continuing with the 40-week extension study, 75 mg of GEMTESA continued to demonstrate efficacy and be well tolerated. These data were presented at the virtual American Urological Association (AUA) Annual Meeting in 2020, and are consistent with the results from the EMPOWUR study, where patients receiving treatment with 75 mg GEMTESA experienced reductions in daily micturitions (urination), UUI, urgency, and total urinary incontinence episodes over the 12-week period. GEMTESA also demonstrated a favorable safety profile over 12 weeks.

Dr. David Staskin, the principal EMPOWUR study investigator and lead author of the Journal of Urology paper, said, “This peer-reviewed journal publication further highlights the results of the EMPOWUR study over the 52-week period, demonstrating the favorable long-term safety, tolerability and efficacy of GEMTESA in patients with overactive bladder, consistent with results of the 12-week EMPOWUR study. This is a potentially important and differentiated new oral treatment for patients suffering with OAB.” Dr. Staskin is a leading urologist with St. Elizabeth’s Medical Center, and an Associate Professor of Urology at Tufts University School of Medicine in Boston.

A total of 12 patients (2.4%) discontinued owing to adverse events. The most common adverse events with vibegron/tolterodine (active control) that were seen in >5% of patients in either group were hypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), headache (5.5%/3.9%), nasopharyngitis (4.8%/5.2%) and dry mouth (1.8%/5.2%).

About the EMPOWUR Trial
The EMPOWUR trial was an international, randomized, double-blind, placebo and active comparator-controlled phase 3 clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. A total of 1,518 patients were randomized across 215 study sites into one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once daily; placebo administered orally once daily; or tolterodine ER 4 mg administered orally once daily.

About the 40-Week EMPOWUR Extension
The EMPOWUR 40-week extension trial was a phase 3, randomized, double blind, active controlled multicenter study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study enrolled approximately 500 EMPOWUR completers. The primary endpoint was safety, measured by incidence of adverse events. Secondary endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total urinary incontinence.

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.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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 2005 merger 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.

Urovant contact:
Ryan Kubota
949.769.2706
ryan.kubota@urovant.com

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Myovant Sciences and Pfizer Announce First Participant Dosed in Phase 3 SERENE Study Evaluating Contraceptive Efficacy of Once-Daily Relugolix Combination Tablet

BASEL, Switzerland and NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the first participant has been dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in healthy women ages 18-35 years who are at risk for pregnancy.

“We are committed to redefining care for women, which means supporting their overall health and quality of life. Many women with uterine fibroids and endometriosis need to simultaneously manage their symptoms and their reproductive choices – including prevention of pregnancy,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “The Phase 3 SERENE study is designed to assess the potential of relugolix combination tablet to prevent pregnancy, and will complement data from our Phase 3 LIBERTY and SPIRIT programs which demonstrated the promise of relugolix combination therapy as a potential treatment for uterine fibroids and endometriosis.”

The SERENE study will enroll 900 sexually active, healthy women ages 18-35 years with presumed normal fertility. The primary efficacy endpoint is the at-risk Pearl Index, defined as the number of on-treatment pregnancies per 100 women-years of treatment. On-treatment pregnancies are pregnancies with an estimated conception date between the first day of study intervention intake up to and including seven days after the last intake of study medication. Women will receive once-daily relugolix combination tablet for 13 28-day at-risk cycles. Safety data will also be collected during the study.

“The findings of the Phase 1 study demonstrated that relugolix combination therapy inhibited ovulation in all the study participants and provided the basis for the SERENE study to evaluate whether relugolix combination tablet has the potential to prevent pregnancy in women receiving therapy,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “The data from this Phase 3 study will provide important information to patients and healthcare providers when making treatment decisions for women with endometriosis and uterine fibroids.”

In April 2020, Myovant announced results from a Phase 1 single-arm, open-label ovulation inhibition study to assess the effects of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) on ovulation inhibition, per the Hoogland-Skouby assessment scale (score < 5). In 67 healthy women over an 84-day treatment period (three cycles), relugolix combination therapy achieved 100% ovulation inhibition and was generally well tolerated. Furthermore, 100% of women resumed ovulation or menses upon discontinuation of treatment, with an average time to ovulation of 23.5 days. Data from this study were previously presented at the American Society for Reproductive Medicine 2020 Virtual Congress.

Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021 target action date. The submission of a New Drug Application for the treatment of moderate to severe pain associated with endometriosis is anticipated in the first half of 2021.

More information can be found at www.clinicaltrials.gov, identifier: NCT04756037.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We have one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Our 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. We are 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 our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients’ Lives 
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking Statements
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 and quotes reflecting Myovant Sciences’ expectations of the SERENE study, including the timing and quality of the clinical results and any potential indication that may result from any regulatory filing; and the expected timing of Myovant’s other regulatory filings and potential approvals. 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 the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether and when the FDA may approve the pending application for relugolix combination tablet for women with uterine fibroids and the potential application for women with endometriosis, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether relugolix will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of relugolix; and 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. 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 February 11, 2021, 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.

Pfizer Disclosure Notice
The information contained in this release is as of April 12, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about relugolix combination tablet for women with uterine fibroids, relugolix combination tablet for women with endometriosis, ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer and a collaboration between Pfizer and Myovant Sciences to develop and commercialize relugolix in advanced prostate cancer and women’s health, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of relugolix; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when the potential application for relugolix for women with endometriosis will be filed with the FDA and whether and when any applications may be filed for relugolix for advanced prostate cancer, for women with uterine fibroids or for women with endometriosis in additional jurisdictions or in any jurisdictions for any other potential indications for relugolix; whether and when the FDA may approve the pending application for relugolix for women with uterine fibroids and the potential application for women with endometriosis and whether and when regulatory authorities may approve any other applications that may be filed for relugolix in other jurisdictions, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether relugolix will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of relugolix; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Myovant Sciences Contacts

Ryan Crowe, Investors
+1 (650) 781-9106
investors@myovant.com

Albert Liao, Media
+1 (650) 410-3055
media@myovant.com

Pfizer Contacts

Media Relations
Steve Danehy
+1 (212) 733-1538
PfizerMediaRelations@pfizer.com  

Investor Relations
Chuck Triano
+1 (212) 733-3901
Charles.E.Triano@Pfizer.com

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Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder

Nationwide availability gives healthcare providers and patients a new treatment option

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.

“Urovant is excited to introduce GEMTESA to the patients and healthcare providers who are in need of a new treatment option to address the bothersome symptoms of OAB,” said Jim Robinson, president and chief executive officer of Urovant. “The launch of GEMTESA is a significant milestone for Urovant, as we are bringing our first product to market. It is also an important moment for the entire urology community, as GEMTESA is the first new, oral branded OAB medication to reach the market in nearly a decade.”

Adults suffering from OAB may experience symptoms of UUI, urgency and urinary frequency, which can have a significant impact on daily activities. GEMTESA is designed to reduce the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine. GEMTESA was approved by the U.S. Food and Drug Administration in December 2020 and is the first and only β3 agonist with urgency data and no blood pressure warning in its label. In clinical studies, GEMTESA has been shown to significantly reduce all three key OAB symptoms compared to placebo at Week 12, and there is no known association with cognitive decline for the beta-3 agonist class.1

“The availability of GEMTESA is an important step forward in providing patients with a safe, effective option to manage their OAB symptoms,” said Scott A. MacDiarmid, M.D., FRCPSC, Urologist, Alliance Urology Specialists. “GEMTESA will enable us to deliver a patient-centric treatment experience, bringing a new beta-3 agonist to the forefront of the OAB treatment landscape.”

“Many patients continue to suffer from the symptoms of OAB,” said Walt Johnston, executive vice president, commercial, Urovant. “Our robust teams are working diligently to bring GEMTESA to urology specialists, those in a long-term care setting, and other healthcare providers. We look forward to making GEMTESA available nationwide, supported by comprehensive physician and patient education.”

To learn more about GEMTESA, please visit GEMTESA.com.

About Overactive Bladder 
OAB is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).2

Approximately 30 million Americans suffer from bothersome symptoms of OAB, which can have a significant impairment on a patient’s day-to-day activities.2,3

What is GEMTESA?

GEMTESA is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

It is not known if GEMTESA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before you take GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have trouble emptying your bladder or you have a weak urine stream; take medicines that contain digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); are breastfeeding or plan to breastfeed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you take GEMTESA).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of GEMTESA? 
GEMTESA may cause serious side effects including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infection, nasal congestion, sore throat or runny nose, diarrhea, nausea and upper respiratory tract infection. These are not all the possible side effects of GEMTESA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Please click here for full Product Information.

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 is a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. and intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Sumitovant Biopharma Ltd. 
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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 2005 merger 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.

  1. Welk, B., & McArthur, E. (2020). Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU International, 126(1), 183–190. https://doi.org/10.1111/bju.15040
  2. Reynolds, W. S., Fowke, J., & Dmochowski, R. (2016). The Burden of Overactive Bladder on US Public Health. Current bladder dysfunction reports, 11(1), 8–13. https://doi.org/10.1007/s11884-016-0344-9
  3. Coyne, K. S., Sexton, C. C., Vats, V., Thompson, C., Kopp, Z. S., & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77(5), 1081–1087. https://doi.org/10.1016/j.urology.2010.08.039

Investor and Media Inquiries:
Ryan Kubota
949.769.2706
ryan.kubota@urovant.com

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Sumitovant Biopharma Completes Acquisition of Urovant Sciences

Merger Follows March 23, 2021 Shareholder Vote

NEW YORK, LONDON, IRVINE, CA & BASEL, SWITZERLAND – March 29, 2021 — Sumitovant Biopharma and Urovant Sciences (formerly Nasdaq: UROV) jointly announced today the completion of the merger in which Sumitovant has acquired all outstanding shares of Urovant Sciences.

The merger agreement and the merger were approved on March 23, 2021 by the affirmative vote of holders of a majority of Urovant’s outstanding shares, and by holders of a majority of Urovant’s outstanding shares that are not held by Sumitovant.

“As with other companies in the Sumitovant family, Urovant will be privately held and maintain its distinct culture and focus while benefiting from the strategic advantages of our unique operating model,” said Myrtle Potter, chief executive officer of Sumitovant. “The Urovant team can fully concentrate on the important task of preparing for its commercial launch of GEMTESA® (vibegron), the first new branded prescription drug for the treatment of overactive bladder (OAB) in nearly a decade. We will continue to build upon our heritage and steadfast commitment to developing and delivering the highest quality therapies to address unmet patient needs.” 

“Today, Urovant Sciences reached an important milestone in the company’s continued evolution and growth. We believe the merger with Sumitovant will help us accelerate our vision of becoming a world-leading urology company,” said James Robinson, president and chief executive officer, Urovant Sciences. “This transaction puts Urovant in an even stronger position to focus on a successful launch of GEMTESA® for patients with OAB, successfully drive our business, continue advancing our development pipeline, and seek further opportunities for business growth.”

Upon the closing of the merger, Urovant shareholders of record, other than Sumitovant, will receive $16.25 in cash for each Urovant common share held. As a result of the merger, Urovant became a wholly owned subsidiary of Sumitovant, and the common shares of Urovant will no longer trade on Nasdaq and will be delisted.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and wholly owns Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant, please visit https://www.sumitovant.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

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 2005 merger 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

Safe Harbor and Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical statements of fact and statements regarding Sumitovant’s, Urovant’s and Sumitomo’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. Forward-looking statements 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. Sumitovant, Urovant and Sumitomo disclaim any obligation to update these forward-looking statements, except as may be required by law.

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

Urovant contact:
Ryan Kubota
949.769.2706
ryan.kubota@urovant.com

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Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

BASEL, Switzerland and NEW YORK, March 24, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced positive data from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

“Since many women with uterine fibroids spend years struggling to manage their symptoms, there is a critical need for non-invasive long-term treatment options,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago and LIBERTY Program Steering Committee Member. “Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.”

The LIBERTY randomized withdrawal study (N = 229) was a Phase 3 double-blind, placebo-controlled study that enrolled eligible women who completed the LIBERTY long-term extension study. Eligibility criteria included meeting the responder criteria at one year. Responder criteria were defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. Women were randomized at Week 52 to once-daily relugolix combination therapy or placebo for a one-year double-blind treatment period. Women on placebo with relapse of heavy menstrual bleeding during the study were offered re-treatment with open-label relugolix combination therapy. This study, together with the LIBERTY 1, LIBERTY 2, and LIBERTY long-term extension studies, was designed to provide data on the safety and efficacy of treatment with relugolix combination therapy for up to two years.

“We are pleased to see the positive data from the LIBERTY randomized withdrawal study which support the potential benefit of longer-term treatment with relugolix combination therapy,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “We look forward to making the full data available at a future medical congress.”

“Uterine fibroids can affect many women during their lifetime with uncomfortable symptoms, such as heavy menstrual bleeding,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We believe that these study results offer encouraging data in support of longer-term efficacy in women suffering from uterine fibroids.”

The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001). All three key secondary endpoints in the LIBERTY randomized withdrawal study were also achieved, including sustained responder rate at two years (Week 104), time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001). Through two years, 69.8% of women who continued on relugolix combination therapy remained responders. 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.

Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.

Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021 target action date.

Myovant Sciences Conference Call
Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time today, March 24, 2021. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

The webcast will be archived on Myovant’s Investor Relations website following the call.

About the Phase 3 LIBERTY Program in Uterine Fibroids 
The Phase 3 clinical program for uterine fibroids consisted of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women could elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy and to evaluate the need for maintenance therapy. Across studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

LIBERTY 1 and 2 met their primary endpoints (p < 0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving relugolix combination therapy in both studies experienced an 84.3% reduction in menstrual blood loss from baseline at Week 24 (p < 0.0001). Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies.

The open-label extension study also met its primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at Week 52. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.

About Myovant Sciences 
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We have one FDA-approved medicine, ORGOVYX™ (relugolix), for adult patients with advanced prostate cancer. Our 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. We are 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 our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Pfizer: Breakthroughs That Change Patients’ Lives 
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

Myovant Sciences Forward-Looking Statements
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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; Drs. Al-Hendy, Arjona Ferreira and Rusnak’s quotes regarding the potential for relugolix combination tablet for uterine fibroids; the expected timing and strength of Myovant’s regulatory filings; and Myovant’s vision for a one pill, once-a-day, treatment option suitable for long-term use in uterine fibroids.

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; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when the FDA may approve the pending application for relugolix combination tablet for women with uterine fibroids and whether and when regulatory authorities may approve any other applications that may be filed for relugolix combination tablet in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the investigational product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether relugolix combination tablet will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of relugolix combination tablet; and whether our collaboration with Pfizer will be successful. 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 February 11, 2021, 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.

Pfizer Disclosure Notice
The information contained in this release is as of March 24, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about relugolix combination tablet, including a potential indication for women with uterine fibroids, and a collaboration between Pfizer and Myovant Sciences to develop and commercialize relugolix in advanced prostate cancer and women’s health, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of relugolix; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for relugolix for advanced prostate cancer or relugolix combination tablet for women with uterine fibroids in any other jurisdictions or for women with endometriosis or any other potential indications in any jurisdictions; whether and when the FDA may approve the pending application for relugolix combination tablet for women with uterine fibroids and whether and when regulatory authorities may approve any other applications that may be filed for relugolix or relugolix combination tablet in any jurisdictions, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether relugolix or relugolix combination tablet will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of relugolix or relugolix combination tablet; whether our collaboration with Myovant Sciences will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Myovant Sciences Contacts

Ryan Crowe, Investors
+1 (650) 781-9106
investors@myovant.com

Albert Liao, Media
+1 (650) 410-3055
media@myovant.com

Pfizer Contacts

Media Relations
Steve Danehy
+1 (212) 733-1538
PfizerMediaRelations@pfizer.com  

Investor Relations
Chuck Triano
+1 (212) 733-3901
Charles.E.Triano@Pfizer.com

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

LONDON and NEW YORK, March 2, 2021 /GLOBE Newswire/ — Sumitovant Biopharma. today announced that its five subsidiary healthcare companies (MyovantUrovantEnzyvantAltavant 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 ORGOVYXTM (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.

Media Contacts:

Sumitovant Biopharma
Mary Stutts
SVP, Corporate Relations
media@sumitovant.com

Myovant Investor Contact:
Ryan CroweVice President, Investor Relations
Myovant Sciences, Inc.
investors@myovant.com

Myovant Media Contact:
Albert Liao 
Director, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

Urovant Investor Contact:
Ryan Kubota
ryan.kubota@urovant.com

Urovant Media Contact:
media@urovant.com

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Altavant Sciences Initiates Chemical Lung Injury Program in Collaboration with the BARDA and NIAID

Cary, N.C. and Basel, Switzerland – February 16, 2021 – Altavant Sciences, a clinical-stage biopharmaceutical company focused on patient-centric drug development in rare respiratory diseases, announced today that the company has partnered with the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) to execute an initial in vivo proof-of-concept pilot study of ALTA-2530, a novel inhaled formulation of a recombinant interleukin-1 receptor antagonist (IL-1Ra), for the treatment of acute and chronic lung injuries caused by the inhalation of sulfur mustard. 

“Exposure to chemical agents, such as sulfur mustard, is commonly associated with the development of a severe and prolonged inflammatory response in the lungs driven by over-activation of the innate immune response,” explained Howard M. Lazarus, M.D., chief medical officer of Altavant. “Research suggests that treatment with a compound such as ALTA-2530 could be a promising approach to mitigate the inflammatory cascade that can yield chronic destructive pulmonary sequelae. By so doing, we may be able to avoid the long-term disability or loss of life that too often occurs after exposure.”

ALTA-2530 has shown promise in the treatment of bronchiolitis obliterans syndrome, a common manifestation of chronic lung allograft dysfunction, in a small investigator-led human study. The NIAID-BARDA collaboration will support a nonclinical research study of ALTA-2530 under the Chemical Countermeasures Research Program (CCRP), an initiative of the National Institutes of Health’s biodefense research program executed and led by the NIAID. The study is designed to establish proof-of-concept that would support further development of ALTA-2530, including pivotal nonclinical studies to establish efficacy and human clinical studies to assess tolerability.

“We share the NIAID and BARDA’s focus on finding treatments for acute and chronic lung injuries resulting from both accidental and intentional exposure to chemical agents,” added William T. Symonds, Pharm.D., chief executive officer of Altavant. “This research collaboration provides an important opportunity to study ALTA-2530 as a treatment for injuries after inhalation of a range of chemicals, pollutants and other toxicants. Findings will guide development of an Altavant program dedicated to bringing forward a treatment for chemical lung injuries, repurposing the asset and broadening our original clinical indication to enhance the care of patients struggling with a variety of respiratory diseases.”

This project has been funded in part with federal funds from BARDA and the NIAID under an Interagency Agreement (IAA AOD20007-001-00000) and Contract No. HHSO100201500004I. 

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 advancing two pipeline candidates: rodatristat ethyl and ALTA-2530. Rodatristat ethyl is in Phase 2 development for patients with pulmonary arterial hypertension. A tryptophan hydroxylase (TPH) inhibitor, rodatristat ethyl 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 formulation of an 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 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 Sumitovant Biopharma Ltd. 
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. Sumitovant Biopharma Ltd. is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. 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/.

Forward-Looking Statements
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:

Aline Sherwood
Scienta Communications, LLC
asherwood@scientapr.com

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Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant Sciences Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

NEW YORK, LONDON, February 17, 2021 (GLOBE NEWSWIRE) — Sumitovant Biopharma Ltd., a majority shareholder of Myovant Sciences (NYSE: MYOV), announced today that the New England Journal of Medicine published Myovant Sciences’ Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.  As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks.

“Peer-reviewed publication of these two important studies in the New England Journal of Medicine is a significant step forward for women who suffer from uterine fibroids, said Myrtle Potter, chief executive officer of Sumitovant Biopharma.  “The results offer hope for a better quality of life and further the mission of Sumitovant Biopharma to develop therapies that make a difference in patients’ lives”.

LIBERTY 1 and LIBERTY 2 each met the primary endpoint, with 73.4% and 71.2% of women in the relugolix combination therapy groups achieving the responder criteria compared with 18.9% and 14.7% of women in placebo groups at Week 24, respectively (both p < 0.001). A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline in each study (both p < 0.001 compared to placebo). 

“We are pleased that the New England Journal of Medicine recognized the importance of our Phase 3 LIBERTY program and published the study results, which support the potential of once-daily relugolix combination therapy in women with uterine fibroids,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “As we approach our FDA target action date of June 1, we look forward, if approved, to providing a one pill, once-a-day treatment for the millions of women with uterine fibroids who need and deserve new options.” 

In LIBERTY 1 and LIBERTY 2, six of seven key secondary endpoints measured at Week 24 achieved statistical significance, including mean reduction in menstrual blood loss, amenorrhea, reduction in pain in women with pain at baseline, improvement on the Bleeding and Pelvic Discomfort scale, reduction in uterine volume (all p < 0.001 compared to placebo), and improvement in anemia in those women with anemia at baseline (both p < 0.05 compared to placebo). In addition, among the approximately 50% of women with moderate-to-severe pain at baseline, a significantly greater proportion of women receiving relugolix combination therapy reported minimal-to-no pain (maximum score of 1 on a 0 to 10 Numerical Rating Scale) during the last 35 days of treatment compared to placebo (43% vs. 10% and 47% vs. 17%, respectively; both p < 0.001). A seventh key secondary endpoint for reduction in fibroid volume was not achieved in either study.

Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2. The overall incidence of adverse events in the relugolix combination and placebo groups were also comparable (62% vs. 66% and 60% vs. 59%, respectively), including hot flashes (11% vs. 8% and 6% vs. 4%, respectively). There were no pregnancies reported in the relugolix combination groups in either study. 

Data from LIBERTY 1 and LIBERTY 2, in addition to the 28-week long-term extension study, were included in the New Drug Application for relugolix combination tablet for uterine fibroids, with an FDA decision expected by the June 1, 2021 target action date. Myovant previously announced results from the LIBERTY long-term extension study in February 2020. At one year, 87.7% of women receiving relugolix combination therapy met the responder criteria. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year. Changes in bone mineral density and the incidence of adverse events were consistent with those in LIBERTY 1 and LIBERTY 2. 

About Uterine Fibroids

Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual’s genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth. 

Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.

An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated three million women are inadequately treated by current medical therapy and require further treatment.

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

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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 2005 merger 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

Sumitovant Biopharma and Myovant Sciences Forward-Looking Statements

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 and quotes reflecting Myovant Sciences’ expectations, including Myovant Sciences’ aspiration to redefine care for women and for men; quotes regarding the potential for relugolix combination tablet for uterine fibroids; the expected timing and strength of Myovant’s regulatory filings; and Myovant’s vision for a one pill, once-a-day, treatment option suitable for long-term use in uterine fibroids.

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, the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities and whether regulatory authorities will be satisfied with the design of and results from the clinical studies. 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 November 12, 2020, 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.

Myovant Sciences Investor Contact
Ryan Crowe
+1 (650) 781-9106
investors@myovant.com


Media Contacts:

Sumitovant Biopharma
Mary Stutts
SVP, Corporate Relations
media@sumitovant.com

Myovant Sciences
Albert Liao 
Director, Corporate Communications
media@myovant.com

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Urovant Sciences Provides Merger Update and Reports Third Quarter Fiscal Year 2020 Results

February 12, 2021 at 4:05 PM EST

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Feb. 12, 2021– Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended December 31, 2020.

“The third quarter of fiscal 2020 was transformational for Urovant. In November, we announced the signing of a definitive merger agreement with Sumitovant Biopharma, the majority shareholder of Urovant. Under the terms of the definitive agreement, Urovant will be acquire by Sumitovant Biopharma at a 96% premium to the closing price of our shares prior to the agreement being announced. We look forward to obtaining shareholder approval for the merger at a special general meeting that we expect to take place at the end of 1Q CY2021,” said James Robinson, president and chief executive officer of Urovant Sciences.

“In December of 2020, Urovant also achieved a significant milestone with the FDA’s approval of GEMTESA for the treatment of patients suffering from overactive bladder, or OAB. We have recently completed the hiring of our sales force and look forward to launching GEMTESA in the coming weeks,” concluded Mr. Robinson.

Merger Update
The Urovant Board authorized and approved the definitive merger agreement with Sumitovant Biopharma and the management team is fully supportive of the transaction. The Board recommends that Urovant shareholders vote in favor of the merger at the upcoming special general meeting for shareholders, which is expected to be held next month. The Company requests that all shareholders carefully read the definitive proxy statement that will be mailed to shareholders, and then submit their proxy cards in time for the special general meeting of shareholders. If shareholders approve the merger, Urovant will become a wholly owned subsidiary of Sumitovant Biopharma.

Urovant Recent Business Highlights and Updates

Expected Upcoming Events

Details of the Previously Announced Merger Agreement with Sumitovant Biopharma
On November 12, 2020, Sumitovant Biopharma entered a definitive agreement to acquire all the outstanding shares of Urovant. Under the terms of the merger agreement, a wholly owned subsidiary of Sumitovant will merge with and into Urovant, with Urovant surviving the merger as a wholly owned subsidiary of Sumitovant Biopharma. In the merger all outstanding shares of Urovant stock (other than those held by Sumitovant Biopharma) will be cancelled and converted into the right to receive $16.25 per share.

The closing of the merger is subject to certain limited customary conditions, including the approval of a majority of the minority shareholders. A special general meeting of shareholders to approve the pending merger of the Company with Sumitovant Biopharma is expected to occur by the end of 1Q CY2021. If approved by the shareholders, the transaction is expected to close shortly after the vote. Following the transaction, Urovant will become a wholly owned subsidiary of Sumitovant.

Third Fiscal Quarter 2020 Financial Summary
For the quarter ended December 31, 2020, total operating expenses were $45.6 million, comprised of research and development expenses of $15.6 million and general and administrative expenses of $30.0 million. Net loss for the quarter ended December 31, 2020 was $46.8 million, or $1.46 per share. Cash used in operations was $46.8 million. As of December 31, 2020, total cash was $71.3 million.

No Conference Call 
Due to the pending Sumitovant Biopharma merger, the company will not be holding a quarterly earnings call.

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

About Sumitovant Biopharma Ltd. 
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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

Additional Information and Where to Find It
This communication is being made in respect of the proposed transaction involving Urovant and Sumitovant. Urovant intends to file with the Securities and Exchange Commission (“SEC”) relevant materials, including a proxy statement on Schedule 14A in connection with the proposed transaction with Sumitovant, and Urovant and certain other persons, including Sumitovant, intend to file a Schedule 13E-3 transaction statement with the SEC. The definitive proxy statement and Schedule 13E-3 transaction statement will be sent or given to the shareholders of Urovant and will contain important information about the proposed transaction and related matters. UROVANT’S SECURITYHOLDERS ARE URGED TO READ THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION, THE SCHEDULE 13E-3 AND ANY OTHER RELEVANT DOCUMENTS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The proxy statement, Schedule 13E-3 and other relevant materials (when they become available), and any other documents filed by Urovant with the SEC, may be obtained free of charge at the SEC’s website, at www.sec.gov. In addition, securityholders of Urovant will be able to obtain free copies of the proxy statement and Schedule 13E-3 through the Investor Relations page of Urovant’s website, www.urovant.com, or by contacting Urovant’s Investor Relations Department by mail at Attention: Investor Relations, 5281 California Ave, Suite #100, Irvine, CA 92617, or by telephone at (949) 769-2706.

Participants in the Solicitation
Urovant, Sumitovant and their respective directors, executive officers, and other members of management and certain of their respective employees may be deemed to be participants in the solicitation of proxies in connection with the proposed merger. Information about Urovant’s directors and executive officers is included in Urovant’s Annual Report on Form 10-K for the year ended March 31, 2020 filed with the SEC on June 19, 2020, and the proxy statement for Urovant’s annual meeting of shareholders for 2020, filed with the SEC on July 27, 2020. Additional information regarding these persons and their interests in the merger will be included in the proxy statement and Schedule 13E-3 relating to the proposed merger when they are filed with the SEC. These documents, when available, can be obtained free of charge from the sources indicated above.

Safe Harbor for Forward-looking Statements
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical statements of fact and statements regarding Urovant’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding expectations about the proposed transaction involving Urovant and Sumitovant, statements regarding Urovant’s expectations for the commercialization of vibegron for the treatment of overactive bladder and plans and strategies for the clinical development of vibegron and other treatments for urologic diseases. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. Risks and uncertainties related to the proposed merger include, but are not limited to, the risk that the merger transaction does not close, due to the failure of one or more conditions to closing or otherwise; the risk that required Urovant shareholder approvals of the merger transaction will not be obtained or that such approvals will be delayed or conditioned beyond current expectations; risks related to the disruption of management time from ongoing business operations due to the proposed transaction and possible difficulties in maintaining customer, supplier, key personnel and other strategic relationships; and the possibility of unexpected costs, liabilities or litigation related to the proposed transaction. Additional risks and uncertainties related to Urovant and its business include, but are not limited to, Urovant’s dependence on the success of its lead product candidate, vibegron, including uncertainties regarding FDA approval; the failure to achieve the market acceptance necessary for commercial success for vibegron or any other product candidate; the success and cost of Urovant’s efforts to commercialize vibegron; the impact on Urovant’s business, financial results, results of operations and ongoing clinical trials from the effects of the COVID-19 pandemic; risks related to clinical trials, including uncertainties relating to the success of Urovant’s clinical trials for vibegron and URO-902 and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; Urovant’s dependence on Merck Sharp & Dohme Corp. and Ion Channel Innovations, LLC to have accurately reported results and collected and interpreted data related to vibegron and URO-902 prior to Urovant’s acquisition of the rights related to these product candidates; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain, and enforce intellectual property protection for Urovant’s technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; Urovant’s ability to realize the anticipated benefits of the co-promotion agreement with Sunovion in the manner or timeline expected; and other risks and uncertainties listed in Urovant’s filings with the SEC, including under the heading “Risk Factors” in Urovant’s most recently filed Quarterly Report on Form 10-Q, 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.

UROVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations
(unaudited; in thousands, except share and per share data)

Unless otherwise noted, the three and nine months comparisons are to the prior fiscal year comparable period ended December 31, 2019.

 Three Months Ended December 31,Three Months Ended December 31,Nine Months Ended December 31, Nine Months Ended December 31,
 202020192020 2019
Operating expenses:
Research and development(1)$15,616$23,099$46,506$62,909
General and administrative(2)29,96516,68761,38729,587
Total operating expenses45,58139,786107,89392,496
Other (expense) income:
Interest expense, net(1,615)(1,401)(4,522)(2,495)
Loss on disposal of property and equipment(236)
Other income (expense), net271(34)(155)(145)
Loss before (benefit from) provision for income taxes(46,925)(41,221)(112,570)(95,372)
(Benefit from) provision for income taxes(128)38(123)113
Net loss$(46,797)$(41,259)$(112,447)$(95,485)
Net loss per common share—basic and diluted$(1.46)$(1.36)$(3.59)$(3.14)
Weighted average common shares outstanding—basic and diluted32,101,83230,413,94631,355,19030,365,142

(1) Includes $404 and $1,192 and #$2,844 and $3,366 of share-based compensation expense during the three and nine months ended December 31, 2020 and 2019, respectively.
(2) Includes $5,516 and $8,132 and $9,685 and $11,431 of share-based compensation during the three and nine months ended December 31, 2020and 2019, respectively.

Condensed Consolidated Balance Sheets
(unaudited; in thousands)

Unless otherwise noted, the three months comparisons are to the prior fiscal year comparable period ended March 31, 2020.

 December 31, 
2020
March 31, 
2020
Assets  
Current assets:  
Cash$71,295 $51,414
Restricted cash 250 243
Prepaid expenses and other current assets 14,509 6,489
Due from Sumitovant Biopharma Ltd. — 172
Total current assets 86,05458,318
Property and equipment, net2,020 1,210
Operating lease right-of-use assets 3,705 3,135
Intangible asset, net14,000
Restricted cash, net of current portion 2,198 623
Other assets 910 9
Total assets$108,887 $63,295
   
Liabilities and Shareholders’ Deficit  
Current liabilities:  
Accounts payable$3,509 $1,589
Accrued expenses 35,113 21,756
Due to Roivant Sciences Ltd. — 31
Due to Sunovion Pharmaceuticals, Inc.182
Current portion of share-based compensation liabilities 1,112 7,204
Current portion of operating lease liabilities 520 351
Total current liabilities40,436 30,931
Share-based compensation liabilities, net of current portion1,19532
Related-party long-term debt209,285 87,252
Operating lease liabilities, net of current portion3,588 3,086
Total liabilities254,504 121,301
Total shareholders’ deficit (145,617) (58,006)
Total liabilities and shareholders’ deficit$108,887$63,295 

View source version on businesswire.com: https://www.businesswire.com/news/home/20210212005509/en/

Investor and Media Inquiries: 
Ryan Kubota
949.769.2706 
ryan.kubota@urovant.com 

Source: Urovant

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Urovant Sciences Announces Progression of URO-902 Phase 2a Trial Following Positive Recommendation from the Data and Safety Monitoring Board

February 11, 2021 at 8:00 AM EST

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Feb. 11, 2021– Urovant Sciences (Nasdaq: UROV) announced today that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of the phase 2a study of URO-902, a novel gene therapy product, in patients with overactive bladder (OAB) and urge urinary incontinence (UUI).

URO-902 has the potential to be the first gene therapy for patients with OAB. Following the recommendation of the DSMB, Urovant is proceeding with opening cohort 2 of the study with a dose of 48 mg or placebo.

About the Phase 2a Study 
This randomized, double blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of a single administration of URO-902, a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. URO-902 is administered via direct intradetrusor injections into the bladder wall under local anesthesia in patients who are experiencing OAB symptoms and UUI.

The Phase 2a trial is expected to enroll approximately 80 female patients in two cohorts: the first cohort received either a single administration of 24 mg of URO-902 or matching placebo into the bladder wall, and the second cohort will receive 48 mg of URO-902 or matching placebo into the bladder wall. Patients will be followed for up to 48 weeks after initial administration. The primary outcome measure is the change in the average daily number of UUI episodes from baseline at week 12, as well as assessing the safety and tolerability of this new potential therapy.

About URO-902
URO-902 has the potential to be the first gene therapy for patients with OAB. This innovative treatment has the potential to address an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions related to existing third-line OAB treatments.

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.

About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. 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 2005 merger 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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development of URO-902 in patients with OAB. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success and cost of Urovant’s efforts to commercialize vibegron; Urovant’s ability to realize the anticipated benefits of the co-promotion agreement with Sunovion in the manner or timeline expected; Urovant’s reliance on Sunovion for the co-promotion and distribution of vibegron and Urovant’s ability to secure alternative access to commercial infrastructure or strategic collaborations for the commercialization or distribution of products if it is unable to continue the relationship with Sunovion; the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s 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.

Media Contacts:

Urovant Sciences 
Ryan Kubota
ryan.kubota@urovant.com
949-769-2706

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