Roivant Statement on Positive Phase 3 Results from Myovant's LIBERTY 1 Study in Uterine Fibroids

NEW YORK and BASEL, Switzerland, May 14, 2019 /PRNewswire/ — Roivant subsidiary Myovant Sciences today announced positive topline results from its Phase 3 LIBERTY 1 trial of relugolix combination therapy in women with uterine fibroids. An estimated 5 million women in the U.S. suffer from symptoms of uterine fibroids. Myovant expects topline data from a replicate Phase 3 study, LIBERTY 2, in the third quarter of 2019. If successful, Myovant plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the fourth quarter of 2019.

"I would like to congratulate the Myovant team on these positive Phase 3 results from LIBERTY 1. We're incredibly proud of the team's efforts to improve the lives of women with limited options today," said Dr. Mayukh Sukhatme, President of Roivant Pharma. "These results come within several months of other positive clinical data readouts elsewhere in the Roivant family. We look forward to six additional Phase 3 readouts as well as numerous earlier-stage clinical results across the Roivant family over the next 18 months."

Roivant will host its second annual Pipeline Day on Thursday, June 6, 2019 in New York. The event will feature presentations and Q&A sessions from executives across the Roivant family of companies highlighting new clinical data and investments in technology. A live webcast will be available to interested parties. Please email [email protected] 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.

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SOURCE Roivant Sciences

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