Roivant launches Urovant with phase 3 Merck med

Vivek Ramaswamy’s Roivant Sciences has launched yet another new biotech, this time called Urovant and focused on urologic disorders.

Urovant will be working on its lead therapeutic candidate, vibegron, an oral β3-adrenergic agonist in testing for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed the global rights (exc. Japan and certain Asian territories) wo work on and sell vibegron (formerly MK-4618) from Merck. Back in 2014, Merck gave biopharma Kyorin an exclusive license to develop, manufacture and sell vibegron in Japan.

A recent phase 2b study of over 1,300 subjects that hit its primary endpoints, and there has also been a completed placebo and active comparator-controlled phase 3 that also met its primary and “key secondary endpoints.”

Urovant says it plans to start a phase 3 registration program for vibegron this year. This comes as Merck has been re-tooling some of its R&D in recent years, with urology no longer a key pipeline focus.

“We are delighted to welcome another ‘Vant’ to our growing family of companies,” said Vivek Ramaswamy, founder and CEO of Roivant Sciences. “Urologic conditions such as overactive bladder adversely impact millions of individuals, and the current treatment options are unsatisfactory for many patients. Our aim is to provide patients with better options as quickly as possible.”

Financial terms of the deal were not disclosed.

Roivant itself is working on a number of therapeutic areas such as rare diseases, oncology and neurology, and has a history of tie-ups, having formed partnerships with Takeda, Eisai and GlaxoSmithKline, to name but a few.

It’s also become a master of the spinout game, having successfully launched Axovant Sciences (formerly Roivant Neurosciences) a few years ago, and helped with its huge $315 million IPO, masterminded by the company’s young former hedge fund manager Ramaswamy. Another spinout, called Myovant and created in conjunction with Takeda, is also in the mix for the company.

Last July, Roivant and Plexcera Therapeutics also launched another new biotech with a singular focus on the ultrarare condition known as Farber disease. The biotech, Enzyvant Sciences, is currently finishing preclinical studies in recombinant human acid ceramidase , an enzyme replacement therapy for patients with Farber disease.