Urovant Sciences Reports Positive Long-Term Data from the Double-Blind Extension of the Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder

September 24, 2019 at 9:00 AM EDT

PDF Version

  •  Vibegron further improved treatment benefit on key overactive bladder (OAB) symptoms over the 40-week extension period 
  •  41% of patients on vibegron became “dry,” defined as having no urge urinary incontinence episodes at week 52 
  •  Vibegron demonstrated a favorable long-term safety and tolerability profile consistent with previous clinical experience 
  •  Over 2,600 OAB patients have been treated with vibegron in clinical trials  
  •  New Drug Application for vibegron expected to be submitted by early 2020 

 IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Sep. 24, 2019–

 Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced positive data from the ongoing double-blind extension of the Phase 3 trial of its investigational drug candidate vibegron, a next-generation, once-daily oral beta-three adrenergic agonist in development for the treatment of overactive bladder.

As previously reported, once-daily vibegron met both co-primary endpoints in the 12-week Phase 3 EMPOWUR study, 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).

Highlights from the double-blind extension of the Phase 3 EMPOWUR study include:

  • Vibegron further improved treatment benefit on key OAB symptoms (micturitions, UUI, urgency, and total incontinence) over the 40-week extension period
  • 61% of patients on vibegron achieved at least a 75% reduction in their daily urge urinary incontinence episodes from baseline at week 52
  • 41% of patients on vibegron became “dry,” defined as having no urge urinary incontinence episodes at week 52
  • Vibegron demonstrated a favorable long-term safety and tolerability profile consistent with previous clinical experience

“The double-blind extension of the EMPOWUR study provides further compelling data that vibegron has the potential to provide long-term benefits for people suffering with overactive bladder,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer at Urovant. “These data increase our confidence in the vibegron OAB development program and we believe vibegron has the potential, if approved by the FDA, to become an exciting next-generation treatment option for patients suffering from OAB.”

More details from the extension study will be presented at future medical meetings. Urovant intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020.

 About EMPOWUR 

EMPOWUR was 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, 506 patients who completed the EMPOWUR trial were enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment up to 52 weeks. The co-primary endpoints of the EMPOWUR study were: 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. 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 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, 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.

 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 vibegron 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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190924005359/en/

Source: Urovant Sciences

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

Urovant Sciences Parent Company, Roivant Sciences, and Sumitomo Dainippon Pharma Enter into a Memorandum of Understanding to Create Broad Strategic Alliance

September 6, 2019 at 9:00 AM EDT

PDF Version

  • Sumitomo Dainippon Pharma is expected to fully assume Roivant’s ownership interest of Urovant Sciences (approximately 75% of outstanding Urovant shares); definitive agreement expected by the end of October 2019
  • Sumitomo Dainippon Pharma is a top-ten Japanese listed multi-national pharmaceutical company with an extensive history of innovation in drug development and commercialization. Sumitomo Dainippon Pharma has over 6,000 employees and generated over $4 billion in revenue last year through commercialization of several large market pharmaceutical drugs in the U.S., including the blockbuster drug LATUDA®
  • Upon close, this transaction will provide Urovant Sciences with a global platform, enhanced commercialization resources and infrastructure, including, but not limited to, managed care, drug distribution, and manufacturing

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Sep. 6, 2019– Urovant Sciences (Nasdaq: UROV) today announced that its parent company, Roivant Sciences, and Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading global Japanese pharmaceutical company, have entered into a non-binding memorandum of understanding for the creation of a significant multi-national Sumitomo Dainippon-Roivant Alliance (“Alliance”) that will include Roivant’s ownership interests in Urovant Sciences and four additional biopharmaceutical “Vant” companies. Roivant will collaborate with Sumitomo Dainippon Pharma, with continued involvement of Roivant’s senior leaders, to ensure the success of the Alliance and the continued support of Urovant Sciences in its mission to develop and commercialize innovative therapies for urologic conditions. Roivant and Sumitomo Dainippon Pharma expect to sign the definitive agreement for their Strategic Alliance by the end of October 2019. The transaction will be subject to customary closing conditions and any required governmental approvals.

Sumitomo Dainippon Pharma plans to support the commercialization of vibegron by leveraging the potential benefits of scale of Sumitomo Dainippon Pharma’s global commercial infrastructure including but not limited to, market access, drug distribution and manufacturing.

“We look forward to this promising new Alliance which provides significant advantages for us as we prepare for the commercial launch of vibegron,” said Keith Katkin, CEO of Urovant. “Our planned NDA filing and launch preparation for vibegron are well underway and will benefit from the partnership of a large, successful multi-national company. In addition, we are excited to have the strategic infrastructure support and proven commercial resources of Sumitomo Dainippon. This relationship should greatly enhance Urovant Sciences’ commercial approach to the US market, strengthens supply chain capabilities and should allow Urovant to fully optimize its launch plan for vibegron.”

Earlier this year, Urovant Sciences announced positive top-line data from the pivotal Phase 3 EMPOWUR trial evaluating vibegron in adults with symptoms of overactive bladder (OAB). Urovant Sciences is planning to submit a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by early 2020. Urovant Sciences has also completed enrollment in Part 1 of its two-part Phase 3 study evaluating vibegron for symptoms of overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH). In addition, Urovant Sciences is enrolling a Phase 2 study evaluating the treatment of vibegron in patients with abdominal pain related to IBS and also expects to start patient enrollment in a Phase 2a trial evaluating novel gene therapy product URO-902 in patients with OAB by the end of the fourth quarter of 2019.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved both co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a Phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a Phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at 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. Roivant today is comprised of a central technology-enabled platform and 20 Vants with over 45 investigational medicines in clinical and preclinical development and multiple healthcare technologies. For more information, please visit www.roivant.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 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 Roivant Sciences and Sumitomo Dainippon Pharma’s plans with respect to the Alliance, including the timing of entry into the definitive agreement, timing of closing of the Alliance and post-closing management of Urovant; the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; the Company’s expectations regarding its anticipated NDA filing for vibegron for OAB; the Company’s expectations regarding its study of vibegron in men with OAB and BPH and its study of vibegron in patients with abdominal pain related to IBS; and the Company’s expectations regarding its Phase 2a study for URO-902.

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 possibility that Roivant and Sumitomo Dainippon Pharma may not enter into a definitive agreement on the terms or timing described in this press release or at all; the possibility that Roivant and Sumitomo Dainippon Pharma may be unable to obtain required governmental approvals or that other conditions to closing the transaction may not be satisfied, such that the transaction will not close or that the closing may be delayed; the potential impact to the Company if the Alliance is deemed to constitute a change in control of the Company, including under its debt and other material agreements and with respect to its tax attributes; the Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the Company’s reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’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; the Company’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 the Company’s acquisition of the rights related to these product candidates; reliance on third parties to conduct, supervise and monitor the Company’s clinical trials; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain and enforce intellectual property protection for the Company’s technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; the failure to achieve the market acceptance necessary for commercial success for a product candidate; the Company’s ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; 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. 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.

The Memorandum is not legally binding with the exception of some stipulations. The two companies will continue to conduct necessary due diligence and engage in mutual consultations as required as they work toward the conclusion of a legally binding definitive agreement concerning detailed conditions, etc. of the Strategic Alliance by the end of October 2019.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190906005086/en/

Source: Urovant Sciences

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

Urovant Sciences to Report 2019 First Fiscal Quarter Financial Results

August 6, 2019 at 8:00 AM EDT

PDF Version

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Aug. 6, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will report 2019 first fiscal quarter financial results after the close of U.S. financial markets on Tuesday, August 13, 2019.

Management will host a conference call to discuss Urovant’s financial results at 1:30 p.m. Pacific Time that same day. A question and answer session will follow management’s remarks.

The conference call numbers are (866) 470-1049 for domestic callers and (409) 217-8245 for international callers. The conference ID is 7747888.

A replay of the call will be available approximately four hours after the call and accessible for 7 days at (855) 859-2056, conference ID 7747888. 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 Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved both co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005207/en/

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Urovant Sciences to Report Financial Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019

June 6, 2019 at 8:00 AM EDT

PDF Version

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Jun. 6, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will report financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2019 after the close of U.S. financial markets on Thursday, June 13, 2019.

Management will host a conference call to discuss Urovant’s financial results at 1:30 p.m. Pacific Time that same day. A question and answer session will follow management’s remarks.

The conference call numbers are (866) 470-1049 for domestic callers and (409) 217-8245 for international callers. The conference ID is 1883414.

A replay of the call will be available approximately four hours after the call and accessible for 7 days at (855) 859-2056, conference ID 1883414. 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 Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190606005124/en/

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Copyright 2018 © All Rights Reserved