Urovant Sciences to Announce Topline Results from the EMPOWUR Phase 3 Study of Vibegron in Patients with Overactive Bladder

March 18, 2019 at 4:05 PM EDT

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Mar. 18, 2019–
Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will host a conference call and live webcast to discuss topline results from the EMPOWUR international pivotal phase 3 study on Tuesday, March 19, 2019 at 8:30 a.m. ET. A question and answer session will follow management’s remarks.

The conference call numbers are (866) 470-1049 for domestic callers and+1 (409) 217-8245 for international callers. The conference ID is 9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.

A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406 for international callers. The conference ID is 9455883. A webcast will be archived on the Investor Relations page of the Urovant Sciences website immediately after the call and available for at least 30 days.

About Overactive Bladder

Overactive bladder is a clinical condition characterized by the sudden urge to urinate that is difficult to control (urgency), with or without accidental urinary leakage (urge urinary incontinence), and usually with increased frequency of urination. The exact cause is unknown, making this a difficult condition to treat. In the United States, more than 30 million people over the age of 40 suffer from the bothersome symptoms of OAB1, which can lead to depression, anxiety and a negative impact on quality of life.2

About EMPOWUR

EMPOWUR is an international randomized, double-blind placebo- and active comparator controlled 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. Additionally, 507 patients who completed the EMPOWUR trial were enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment. The co-primary endpoints of the EMPOWUR study are: change from baseline in the average number of micturitions per 24 hours in all patients; and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have one or more UUI episodes per day prior to treatment. Secondary endpoints included changes in the frequency of urinary urgency episodes and incontinence episodes, and self-reported quality of life scores.

About Urovant Sciences

Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, is a subsidiary of Roivant Sciences. Urovant leverages the. Roivant platform to develop therapies that address high unmet medical needs while driving greater efficiency in research, clinical development, and commercialization. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 adrenergic agonist being evaluated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency; for OAB in men with benign prostatic hyperplasia; and for abdominal pain associated with irritable bowel syndrome. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacological therapy. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit www.urovant.com.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.

1. Coyne, et al., EpiLUTS 2007
2. Kinsey D, et al., J Health Psychol. 2016

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder

OWUR Study of Vibegron in Patients with Overactive Bladder
March 19, 2019 at 8:00 AM EDT

  • Vibegron met both co-primary endpoints demonstrating highly significant reduction in daily urge urinary incontinence episodes and micturitions, compared to placebo (p<0.0001 and p<0.001, respectively)
  • Vibegron met all seven key secondary endpoints, including a clinically meaningful reduction in daily urgency episodes versus placebo (p=0.002)
  • Vibegron achieved rapid onset at two weeks in both co-primary endpoints and daily urgency episodes (p<0.001 for these endpoints) and statistically significant efficacy was maintained at all timepoints measured through the end of the study
  • Vibegron could potentially be the first new prescription drug in nearly a decade for the millions of patients suffering from overactive bladder (OAB)
  • Urovant to host investor conference call March 19, 2019

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Mar. 19, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced positive topline results from EMPOWUR, an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of vibegron 75mg in adults with symptoms of overactive bladder. Vibegron is an investigational once-daily oral beta-three adrenergic agonist.

In the primary efficacy analysis, once-daily vibegron met the co-primary endpoints at week 12, achieving statistical significance over placebo on both reduction in daily urge urinary incontinence (UUI) episodes (p<0.0001) and reduction in daily micturitions (p<0.001). The difference from placebo was statistically significant as early as week 2, which was the first timepoint measured, for both UUI episodes and micturitions (p<0.0001 and p<0.001, respectively), and statistically significant efficacy was maintained at all timepoints measured through the end of the study for both endpoints. Additionally, at all measured timepoints, vibegron achieved numerically better efficacy than tolterodine, the active control in this study, which is a currently available OAB treatment.

All seven pre-specified key secondary endpoints were met, including a statistically significant reduction in daily urgency episodes compared to placebo (p=0.002). Other endpoints that were not part of the topline data analysis will be presented at future medical meetings.

Vibegron was well tolerated and the most common adverse events reported versus placebo (>2% in vibegron and greater than placebo) were headache (4.0% vs 2.4%), nasopharyngitis (2.8% vs 1.7%), diarrhea (2.2% vs 1.1%), and nausea (2.2% vs 1.1%). The frequency of serious adverse events was similar across treatment arms (1.1% in placebo, 1.5% in vibegron, and 2.3% in tolterodine). The incidence of the reported adverse event of hypertension was and 2.6% in tolterodine). Full vital sign data, including blood pressure, were not part of the topline data analysis.

Based on these topline results, Urovant intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020. EMPOWUR results will be presented at the American Urological Association Annual Meeting in Chicago in May of this year.

“There is a significant need for innovative new treatment options for OAB patients, as many patients are unable to find relief with currently available medicines,” said Dr. David R. Staskin, a key investigator in the EMPOWUR study, a leading urologist with St. Elizabeth’s Medical Center, and an Associate Professor of Urology at Tufts University School of Medicine in Boston. “The strong efficacy and safety topline results from the EMPOWUR study suggest that vibegron, if approved by the FDA, could provide an exciting next-generation treatment option for patients suffering from OAB.”

“We believe these efficacy and safety results represent a significant advancement in the treatment of OAB, positioning vibegron as a potential best in class therapy,” said Keith A. Katkin, Chief Executive Officer of Urovant. “Vibegron, if approved, could potentially be the first new prescription drug in nearly a decade for the millions of women and men suffering from OAB.”

About EMPOWUR

EMPOWUR is an international randomized, double-blind placebo- and active comparator controlled 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. Additionally, 507 patients who completed the EMPOWUR trial were enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment. The co-primary endpoints of the EMPOWUR study are: change from baseline in the average number of micturitions per 24 hours; and change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have an average of one or more UUI episodes per day prior to treatment. incontinence episodes, and self-reported quality of life scores.

Conference Call

Urovant will host a conference call today March 19, 2019 at 8:30 a.m. ET to discuss topline results from EMPOWUR, the international Phase 3 pivotal trial for vibegron. The conference call numbers are (866) 470-1049 for domestic callers and +1 (409) 217-8245 for international callers. The conference ID is 9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.

A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406. The conference ID is 9455883. A webcast will be website immediately after the call and available for at least 30 days.

About Overactive Bladder

Overactive bladder is a clinical condition characterized by the sudden urge to urinate that is difficult to control (urgency), with or without accidental urinary leakage (urge urinary incontinence), and usually with increased frequency of urination. The exact cause is unknown, making. this a difficult condition to treat. In the United States, more than 30 million people over the age of 40 suffer from the bothersome symptoms of OAB1, which can lead to depression, anxiety and a negativeimpact on quality of life.2

About Urovant Sciences

Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, is a subsidiary of Roivant Sciences. Urovant leverages the Roivant platform to develop therapies that address high unmet medical needs while driving greater efficiency in research, clinical development, and commercialization. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 adrenergic agonist being evaluated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency; for OAB in men with benign prostatic hyperplasia; and for abdominal pain associated with irritable bowel syndrome. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacological therapy. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit www.urovant.com.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.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,” “suggest,” “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 the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions, the Company’s plans to file for approval of vibegron with the FDA, and the timing of such filing and the likelihood of FDA approval.

The Company’s forward-looking statements are based on management’s current expectations and beliefs, and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Company’s 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 the Company’s filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed with the SEC on February 14, 2019, as such risk factors may be amended, supplemented or superseded from time to time by other reports the Company files with the SEC. 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, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

1. Coyne, et al., EpiLUTS 2007
2. Kinsey D, et al., J Health Psychol. 2016

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Appoints James Robinson to its Board of Directors

March 6, 2019 at 8:00 AM EST

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Mar. 6, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced James Robinson, President and Chief Operating Officer of Alkermes, will join its Board of Directors.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20190306005182/en/

Urovant Sciences Appoints James Robinson to its Board of Directors (Photo: Business Wire)

Urovant Sciences Appoints James Robinson to its Board of Directors (Photo: Business Wire)

“Jim’s extensive leadership, knowledge and experience in thebiopharmaceutical space combined with his unique understanding of theurology market will help inform Urovant’s strategies and growthopportunities,” said Keith A. Katkin, Chief Executive Officer of Urovant. “Urovant is pleased to welcome him to our board and my team and I are looking forward to his counsel and contributions.”

“Jim has demonstrated unwavering leadership in the competitive and
complex biopharmaceutical market,” said Myrtle Potter, Chairman of the Urovant Sciences Board. “Given the trajectory of Urovant, Jim’s extensive commercial experience will certainly benefit Urovant and its management team.”

Mr. Robinson has more than 27 years of commercial and operations experience in the biopharmaceutical industry, specifically in the urology, oncology, cardiovascular, infectious disease, hepatitis and CNS markets. Since March 2018, he has held the position of President and Chief Operating Officer at Alkermes, where he is responsible for the global commercial, new product planning, corporate planning, anufacturing, quality, human resource and business development functions.

Prior to Alkermes, Mr. Robinson spent over 13 years at Astellas US – most recently as President, Americas Operations, from chron>April 2016 through February 2018, where his responsibilities included all aspects of commercial, corporate development, human resources, finance, corporate affairs, compliance, legal and international operations for North and South America. Prior to his role as President of Americas Operations, Mr. Robinson was President, Astellas Pharma US, from April 2013 through March 2016, where he was responsible for leading the US commercial organization. Prior to Astellas, Mr. Robinson spent 13 years at Schering-Plough Pharmaceuticals where his last role was Vice resident, Hepatitis Sales and Managed Care.

“I am pleased to join Urovant’s board and work with a company that is passionate about developing and commercializing innovative products to address the needs of urology patients who oftentimes suffer in silence,” said Mr. Robinson. “I look forward to working with Keith and his leadership team.”

Mr. Robinson serves on the Board of Directors for Neos Therapeutics. He is a founding member and serves on the Board of Directors of MATTER and is also on the Board of Directors for the Chicago Botanic Garden. He received his Bachelor of Science degree from DePaul University.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic. conditions. Urovant’s lead product treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency; for OAB in men with benign prostatic hyperplasia; and for abdominal pain associated with irritable bowel syndrome. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacological therapy. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit www.urovant.com.

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Announces Publication of Phase 2b Data for Vibegron in European Urology

 

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 1, 2018– Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced the publication of positive results from the international Phase 2b study of vibegron, an investigational oral beta-3 adrenergic agonist being studied for adults with symptoms of overactive bladder (OAB).

The study, which demonstrated once-daily vibegron was well-tolerated and improved OAB symptoms, was published online by European Urology, a peer-reviewed medical journal and official journal of the European Association of Urology.

The international, randomized double-blind, placebo-controlled Phase 2b study including an active comparator enrolled more than 1,300 patients with OAB symptoms including frequent urination, sudden urge to urinate, and urge incontinence (leakage). In the two-part trial, patients were first randomized to once-daily oral vibegron monotherapy (3 mg, 15 mg, 50 mg or 100 mg); tolterodine extended release (4 mg); or placebo for eight weeks. In part two, patients were randomized to monotherapy, combination therapy or placebo and received either vibegron (100 mg); tolterodine (4 mg); combination vibegron (100 mg) and tolterodine (4 mg); or placebo for four weeks.

In part one, patients randomized to vibegron 50 mg and 100 mg had clinically and statistically significant decreases in the daily number of micturitions, urgency urinary incontinence episodes, total incontinence episodes and urgency episodes at week 8, versus placebo. Moreover, as early as week 2, treatment with both vibegron 50 mg and vibegron 100 mg was associated with statistically significant decreases compared to placebo across all of these key overactive bladder endpoints. Vibegron was generally well-tolerated and there were no meaningful differences in incidence or severity of adverse events observed between the treatment groups and placebo. In part two of the study, the efficacy of vibegron monotherapy on the primary endpoint – reduction in micturitions – was statistically significant and similar to results observed in part one. The incidence of dry mouth was higher among patients treated with tolterodine alone or given concomitantly with vibegron, versus those treated with vibegron monotherapy.

In 2017, Urovant licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Earlier this year, Urovant initiated an international Phase 3 clinical program to evaluate the efficacy and safety of vibegron in adults with symptoms of OAB. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration.

About Overactive Bladder

Overactive bladder is a clinical condition characterized by the sudden urge to urinate that is difficult to control (urgency), with or without accidental urinary leakage (urge urinary incontinence), and usually with increased frequency of urination. The exact cause is unknown, making this a difficult condition to treat. In the United States, more than 30 million people over the age of 40 suffer from the bothersome symptoms of OAB1, which can lead to depression, anxiety and a negative impact on quality of life.2

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 agonist being evaluated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacological therapy. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit www.urovant.comwww.urovant.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron, report results of its Phase 3 clinical trial, and develop additional 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. These risks and uncertainties include, but are not limited to, risks associated with: 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; and our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Urovant’s Registration Statement on Form S-1, which was filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on September 26, 2018, as well as any other future filings with the SEC available at www.sec.gov.

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.

1. Coyne, et al., EpiLUTS 2007
2. Kinsey D, et al., J Health Psychol. 2016

Source: Urovant Sciences

Urovant Sciences
Kellie Lao
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Licenses Novel Gene Therapy for Overactive Bladder

  • There are no currently available FDA-approved gene therapy treatments for overactive bladder
  • Urovant expects to initiate Phase 2 hMaxi-K study in 2019

BASEL, Switzerland and IRVINE, Calif., August 28, 2018/PRNewswire – Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing therapies for urologic conditions, today announced it has licensed a novel investigational gene therapy for patients with overactive bladder (OAB) symptoms who have failed oral pharmacologic therapy.

Urovant has licensed global rights for the development and commercialization of hMaxi-K from Ion Channel Innovations. There are no currently available FDA-approved gene therapy treatments for overactive bladder.

hMaxi-K has been evaluated in two Phase 1 studies in OAB patients including a small, double-blind, placebo-controlled Phase 1b clinical trial as an intravesical injection in women with overactive bladder symptoms. Ion Channel Innovations completed the Phase 1b study in 2017 and found hMaxi-K to be generally well tolerated. Clinical results of the trial, which included a limited number of patients (n=13), indicated dose-dependent improvements in urinary urgency and frequency, achieving statistical significance (p<0.05) in the high dose cohort.

“We are pleased to add the gene therapy hMaxi-K to our clinical development portfolio. We are eager to study the potential of hMaxi-K as an alternative therapy for OAB patients who are not getting adequate relief from other therapies,” said Keith A. Katkin, President and Chief Executive Officer of Urovant. “Urovant also has access to gene therapy expertise through the Roivant family of companies.”

Urovant plans to meet with the FDA and initiate a Phase 2 clinical study in 2019 to investigate hMaxi-K as a novel treatment for OAB patients who have not responded to other pharmacological therapies.

Earlier this year, Urovant initiated a Phase 3 clinical trial program for vibegron, an investigational oral β3-adrenergic agonist being studied as a second-line treatment in adults with symptoms of OAB. Urovant expects to report top-line results for its Phase 3 trial of vibegron next year.

About Overactive Bladder
Overactive bladder is a clinical condition characterized by the sudden urge to urinate, with or without accidental urinary leakage, and usually with increased frequency. The exact cause is unknown, making this a difficult condition to treat. In the United States, more than 30 million people over the age of 40 suffer from the bothersome symptoms of OAB1, which can lead to depression and anxiety and have a negative impact on quality of life.2

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s lead product candidate, vibegron, is a potent and selective β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of hMaxi-K and vibegron. 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, cost and timing of Urovant’s product 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 hMaxi-K and vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. hMaxi-K and vibegron are investigational and have not been approved by the U.S. Food and Drug Administration.

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.

 

  1. Coyne, et al., EpiLUTS 2007
  2. Kinsey D, et al., J Health Psychol. 2016

 

Contacts

Investor inquiries: Investors@Urovant.com

Media inquiries: Media@Urovant.com

Urovant Sciences Appoints Sef Kurstjens and Pierre Legault to its Board of Directors

BASEL, Switzerland and IRVINE, Calif., July [9], 2018 /PRNewswire/ — Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the appointments of Sef Kurstjens, M.D., Ph.D. and Pierre Legault to its board of directors.

“I am excited that Sef Kurstjens and Pierre Legault have agreed to join the Urovant board,” said Keith Katkin, President and Chief Executive Officer of Urovant. “Both Sef and Pierre are accomplished executives with significant experience in the biopharmaceutical industry.”

“I am also pleased by the addition of Sef and Pierre to our board,” said Mayukh Sukhatme, President of Roivant Pharma and the incoming chairman of the Urovant board of directors. “We believe there are big things ahead for Urovant and we look forward to benefiting from Sef’s and Pierre’s expertise and counsel as we grow to meet the unmet medical needs of urology patients.”

Dr. Kurstjens and Mr. Legault join Keith Katkin, Mayukh Sukhatme, M.D. and Matthew Gline on the Urovant board of directors.

Dr. Kurstjens has over 27 years of biotech and pharmaceutical drug development experience, having most recently served as Chief Medical Officer at Astellas Pharma Inc. from 2013 to 2018. Dr. Kurstjens had responsibility for Astellas’ Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance and Quality Assurance divisions, and was a member of the Corporate Executive Committee. Dr. Kurstjens also served as President and Chief Executive Officer at Agensys, Inc., an affiliate of Astellas, from 2010 to 2013.

Prior to joining Astellas, Dr. Kurstjens served as Chief Medical Officer and Head of Global Drug Development at Allergan plc from 2007 to 2013, where he led all Global Drug Development, Clinical Operations, and Drug Safety for the Urology, Neurology, Ophthalmology and Dermatology global therapeutic areas. Dr. Kurstjens received his training in medicine and physiology at the University of the Witwatersrand Medical School in Johannesburg, South Africa.

“I am delighted to join the board of a company focused on meeting the needs of urology patients and I look forward to working with Keith and the rest of Urovant’s highly experienced management team,” said Dr. Kurstjens.

Mr. Legault has over 35 years of experience in the pharmaceutical and biotechnology industries. He currently serves as the Chairman of the board of directors for both Artios Pharma Limited and Poxel SA, as well as a member of the board of directors of Syndax Pharmaceuticals Inc. and Clementia Pharmaceutical Inc. Mr. Legault’s previous roles include serving as Chief Executive Officer of Prosidion Ltd., a subsidiary of Astellas, Chief Financial Officer of OSI Pharmaceuticals, Inc., and various global positions, including President, Chief Executive Officer and Chief Financial Officer at several legacy companies of the Sanofi-Aventis group. Mr. Legault has also served on the board of directors of several other healthcare companies, including Regado Biosciences, Inc. and ARMO Biosciences, Inc. He earned his B.B.A. from HEC Montreal and his M.B.A. from McGill University.

“I am very excited to join the Urovant board of directors,” said Mr. Legault. “Having devoted most of my career to the development and commercialization of therapies in multiple disease areas, I look forward to leveraging my experience to support Urovant as it develops innovative urological drugs.”

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s product candidate, vibegron, is an oral, once-daily, small molecule that, based on in vitro data, is a potent and highly selective beta-3 agonist. Vibegron is currently being evaluated in a large, international pivotal Phase 3 clinical trial for the treatment of overactive bladder (“OAB”). Vibegron is also being evaluated for two additional potential indications, treatment of OAB in men with benign prostatic hyperplasia and the treatment of pain associated with irritable bowel syndrome.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron. 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, cost and timing of Urovant’s product 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; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration or any comparable federal agency in any other jurisdiction.
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.

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