Sumitovant to Snap Up Development Partner Urovant Sciences
As its name aptly suggests, Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions such as overactive bladder (OAB) and maladies involving adjacent areas of the human anatomy.
Sumitovant is a global biopharmaceutical company with a pipeline similarly focused on uterine fibroids, advanced prostate cancer and endometriosis.
Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).
Studies have shown that the beta-3 adrenergic receptor causes relaxation of the smooth urethral muscle, therefore alleviating unpleasant symptoms of OAB like incontinence and the frequent urge to urinate. The condition is most prevalent in men.
Urovant submitted a new drug application (NDA) to the U.S. Federal Drug Administration (FDA) for vibegron in December 2019 after reporting positive data from its 12-week Phase III EMPOWUR study. Vibegron also showed favorable longer-term efficacy, safety, and tolerability in a 40-week extension study.
“Our business is growing, and we remain focused on the potential opportunity to launch vibegron in 2021, pending FDA approval,” said Urovant Sciences President and chief executive officer, James Robinson. “Sumitovant is our largest investor, and we have been partnering closely with them on plans to efficiently launch vibegron and achieve scale as quickly as possible. We believe that this investment represents a vote of confidence in Urovant’s future success and will put us in an even stronger position to bring vibegron to market as a new treatment option for patients with overactive bladder and to continue advancing our promising development pipeline.”
With this resounding vote of confidence from Sumitovant, the future looks bright for Urovant. The company hopes to follow vibegron to the market with URO-902, a novel gene therapy for patients whose OAB has eluded oral pharmacologic therapy. Results of a phase Ib trial completed by Ion Channel Innovations in 2017 indicated dose-dependent improvements in urinary urgency and frequency.
After the agreement is inked, Urovant will become a wholly owned subsidiary of Sumitovant, giving it the flexibility to continue to invest in the development of novel products for urology patients with unmet needs.
Urovant shareholders will receive $16.25 per share, or approximately $584 million in total equity value in this all-cash merger.