Orange County’s adding a pharmaceutical company to its ecosystem that walks quietly and carries a big wallet.
Irvine-based Urovant Sciences Inc. is a subsidiary of Basel, Switzerland-based Roivant Sciences Ltd., which secured $1.1 billion in funding in September. The round was led by Japanese conglomerate SoftBank Group Corp. and made through its $100 billion Vision Fund, which is intended to fuel creation of subsidiaries beyond biopharmaceutical development.
The investment is in Roivant, not its subsidiaries—those include developers of therapies focused on areas including neurology, women’s health and dermatology.
Urovant develops therapies for urologic conditions. It announced a plan to go public last week. Details are scant, but the company seeks $150 million to support research and development, according to Securities and Exchange Commission filings.
R&D
Urovant entered the OC scene in June of last year with a late-stage drug candidate licensed from Kenilworth, N.J.-based pharmaceutical giant Merck & Co. Inc. (NYSE: MRK).
The lead drug candidate, vibegron, is an oral, once-daily drug developed to treat overactive bladder. Urovant has licensed global rights, excluding Japan and other Asian territories, for development and commercialization. Merck licensed the Japanese rights to prescription drugmaker Kyorin Pharmaceutical Co. Ltd. in Tokyo.
The clinical-stage biopharmaceutical company is pursuing indications for overactive bladder; overactive bladder in men with benign prostatic hyperplasia, or age-related prostate gland enlargement that can cause urination difficulty; and pain associated with irritable bowel syndrome.
Urovant is evaluating vibegron in a 1,400-patient international third-phase clinical trial for overactive bladder. It enrolled the first group of patients in March and plans to file for Food and Drug Administration approval by early 2020.
The company estimates there are more than 30 million Americans over 40 with symptoms of overactive bladder, which is characterized by a sudden urge to urinate that’s difficult to control. Nineteen million prescriptions were written last year for approximately 3.3 million U.S. patients for oral overactive bladder medications, according to SEC filings.
Urovant plans a third-phase clinical trial later this year for treatment of overactive bladder in men with benign prostatic hyperplasia and a second-phase trial for treatment of irritable bowel syndrome-associated pain.
The company didn’t respond for comment.
Team
Urovant is led by Chief Executive Keith Katkin, who joined in September and previously served as president and chief executive of Aliso Viejo-based Avanir Pharmaceuticals Inc. The central nervous system disorder-focused drug developer is a subsidiary of Tokyo-based Otsuka Pharmaceutical Co. Ltd.
It rounded out its management team in April with several key hires, including Chief Medical Officer Cornelia Haag-Molkenteller, who was vice president in clinical development and therapeutic-area head for urology, women’s health and internal medicine at Allergan plc. She led multiple development projects, including clinical development of the use of Botox for overactive bladder treatment.
It also appointed Michael McFadden chief commercial officer; Bryan Smith general counsel; Christine Ocampo senior vice president and chief accounting officer; and Nori Ebersole, senior vice president and chief human resources officer. The executives came from or earlier worked at Avanir or Allergan.
‘Vant’ Family
Roivant partners with biopharmaceutical companies and academic institutions to develop late-stage drugs. Chief Executive Vivek Ramaswamy said in a video on the company website that he started Roivant in 2014 to get more medicines to market to help patients. He said many drugs “would never see the light of day … for reasons not to do with science but corporate and financial limitations of the industry we operate in.”
Urovant is part of Roivant’s growing family of “vants”—comprised of Myovant Sciences, which develops treatments for women’s health and prostate cancer; rare disease-focused Enzyvant; Axovant Sciences Ltd. (Nasdaq: AXON), which develops treatments for neurological disorders; cardiometabolic disorders-focused Metavant; Dermavant Sciences Inc., which develops treatments for a broad range of skin diseases; and Genevant, which develops RNA-based therapies for genetic disorders. Genevant, launched in April, is jointly owned by Roivant and Arbutus Biopharma Corp. (Nasdaq: ABUS), which focuses on chronic hepatitis infection, a disease of the liver caused by the Hepatitis B virus.
Datavant, introduced last year, is the first technology-focused subsidiary in the Roivant family. It’s designed to help health organizations safely share and link health data.
The latest “vant” addition is Sinovant Sciences Ltd., which Roivant announced last week. The company, launched in partnership with Chinese private equity firm CITICPE, marks Roivant’s entry into the Chinese market.
Sinovant’s pipeline has 11 investigational drugs for greater China and other Asian markets—late-stage assets include third-phase-ready indications for treating liver cancer, community-acquired pneumonia, and immune deficiency resulting from fatal pediatric disorder DiGeorge Anomaly.
In addition to those, Sinovant received Chinese rights to naronapride, an investigational gastrointestinal drug candidate developed by Menlo Park-based Renexxion. Sinovant plans to develop naronapride to treat irritable bowel syndrome with constipation.
Ramaswamy said its subsidiaries are “an organized decentralized family of ‘vants’” that operate as independent companies with their own management teams and employees with the benefit of scale as part of a larger company.
