Roivant Statement on Topline Results from EMPOWUR Phase 3 Study in Overactive Bladder

NEW YORK and BASEL, Switzerland, March 19, 2019 /PRNewswire/ -- Today Roivant subsidiary Urovant Sciences, Inc. announced topline results from its Phase 3 EMPOWUR trial of vibegron in patients with overactive bladder. Vibegron achieved statistically significant improvements over placebo on both co-primary endpoints of the study as well as all seven key secondary endpoints. Over 30 million Americans over the age of 40 suffer from overactive bladder.

"Today's results, along with our recent positive clinical data at Axovant and our progress at Enzyvant, demonstrate Roivant's ability to advance innovative therapies through all stages of development," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "Over the next year and a half, we look forward to the results of seven additional Phase 3 studies in other disease areas as well as results from numerous earlier-phase studies across the Roivant family."

Roivant anticipates topline data from the following Phase 3 registrational programs:

• Two Phase 3 trials at Myovant for relugolix in uterine fibroids
• Two Phase 3 trials at Myovant for relugolix in endometriosis
• One Phase 3 trial at Myovant for relugolix in advanced prostate cancer
• Two Phase 3 trials at Dermavant for tapinarof in psoriasis

Roivant also expects numerous readouts for earlier-stage programs including the following:

• Immunovant: Phase 2 data in myasthenia gravis and other indications for an anti-FcRn monoclonal antibody administered as a subcutaneous injection
• Altavant: Phase 2 data in pulmonary arterial hypertension for an oral TPH inhibitor
• Respivant: Phase 2 data in IPF cough for an inhaled therapeutic with a proprietary drug-device combination
• Aruvant: Additional Phase 1/2 data in sickle cell disease for a lentiviral gene therapy
• Axovant: Additional Phase 1/2 data for gene therapies in advanced Parkinson's disease, Tay-Sachs disease, and GM1 gangliosidosis

Roivant also anticipates continued growth at its technology-enabled Health Vants, including Datavant and Alyvant, as well as multiple potential regulatory filings for product approvals in the US and other markets.

Roivant will host its second annual Pipeline Day on Thursday, June 6, 2019 in New York to present information on these and other programs. The event will feature presentations, fireside chats, and Q&A sessions from executives across the Roivant family of companies. Due to limited capacity, attendance is by invitation only. A live webcast will be available to interested parties. Please email pipelineday@roivant.com for further information.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. We do 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. 

Media Contact

Paul Davis
Head of Communications
paul.davis@roivant.com

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SOURCE Roivant Sciences