Urovant Sciences Strengthens Executive Management Team with Senior Hires and Establishes U.S. Headquarters in Irvine, California

  • Cornelia Haag-Molkenteller, former VP and Therapeutic Area Head, Clinical Development, for Urology, Women’s Health, and Internal Medicine at Allergan, joins as Chief Medical Officer
  • Michael McFadden, former SVP for Commercial at Avanir, joins as Chief Commercial Officer
  • Bryan Smith, former Senior Counsel at Allergan, joins as General Counsel
  • Christine Ocampo, former Chief Financial Officer at Novus Therapeutics and Chief Accounting Officer at Avanir, joins as SVP and Chief Accounting Officer
  • Nori Ebersole, former Chief Human Resources Officer at Paul Hastings and VP for Human Resources at Allergan, joins as SVP and Chief Human Resources Officer

BASEL, Switzerland and IRVINE, Calif., April 24, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that it has strengthened its management team through the appointment of five senior executives: Cornelia Haag-Molkenteller M.D., Ph.D., as Chief Medical Officer, Michael McFadden as Chief Commercial Officer, Bryan E. Smith as General Counsel, Christine Ocampo as Senior Vice President and Chief Accounting Officer, and Nori Ebersole as Senior Vice President and Chief Human Resources Officer. Urovant also announced that it has established its U.S. headquarters in Irvine, California.

“Cornelia, Michael, Bryan, Christine, and Nori are all outstanding leaders in their respective fields and they will each contribute to Urovant’s success,” said Keith Katkin, Chief Executive Officer of Urovant. “As we continue to enroll patients with overactive bladder in our pivotal Phase 3 trial for vibegron, EMPOWUR, it is critical that we grow our team with the best talent in the industry to simultaneously advance our clinical programs and prepare for the eventual commercialization of our products.”

Dr. Haag-Molkenteller is a board-certified urologist with over 26 years of global experience in clinical development and medical affairs. She most recently served as Vice President and Therapeutic Area Head in Global Clinical Development for Women’s Health, Internal Medicine, Anti-Infectives, and Urology at Allergan. While at Allergan, she led multiple development projects including the clinical development of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity and overactive bladder. Before joining Allergan, Dr. Haag-Molkenteller was Vice President and Therapeutic Area Head for Clinical Development in Urology at Schwarz Biosciences (now UCB) and started her career in the pharmaceutical industry with roles in clinical development and medical affairs at Hoechst-Marion-Roussel (now Sanofi). She received her M.D. and Ph.D. from the Johann Wolfgang Goethe University in Frankfurt-am-Main, Germany and completed her clinical residency in urology in Germany.

Mr. McFadden has over 27 years of experience leading successful drug commercialization efforts across many therapeutic areas including urology. He served as Senior Vice President, Commercial at Avanir Pharmaceuticals and previously held leadership roles in commercial development, marketing, and sales at Amylin Pharmaceuticals, Pharmacia, and Eli Lilly & Company. He has participated in numerous successful pharmaceutical drug launches, including those for NUEDEXTA®, DETROL LA®, BYETTA®, ZYPREXA®, and CELEBREX®. Mr. McFadden received his B.A. in Business Administration and Accounting from Northeast Louisiana University.

Mr. Smith most recently served as Associate Vice President and Senior Counsel at Allergan, where he was chief counsel to the company’s Urology, Neurology, Aesthetics, and Dermatology business units. Mr. Smith also led Allergan’s anti-counterfeiting and anti-diversion efforts in close cooperation with the U.S. Food & Drug Administration’s Office of Criminal Investigations and other federal, state, and international law enforcement agencies. Prior to joining Allergan, Mr. Smith was a litigator at Gibson, Dunn & Crutcher LLP. Mr. Smith received his B.A. in Political Science from Brigham Young University and his J.D. from the University of Southern California Law School. After graduating from law school, Mr. Smith was a law clerk to the Honorable Cormac J. Carney in the United States District Court for the Central District of California.

Ms. Ocampo has over 20 years of accounting and finance experience, including over 15 years as the head of finance for publicly-traded companies in the healthcare industry. She most recently served as Chief Financial Officer of Novus Therapeutics. Before joining Novus, Ms. Ocampo was Chief Accounting Officer and Vice President of Finance at Avanir Pharmaceuticals from 2007 to 2015, where she played a key role in the company’s sale to Otsuka Pharmaceutical Co., Ltd. Prior to Avanir, she served as Senior Vice President, Chief Financial Officer, Chief Accounting Officer, Treasurer and Secretary of Cardiogenesis Corporation. After earning a B.A. in Business and Accounting from Seattle University, Ms. Ocampo began her career at Ernst & Young LLP. Ms. Ocampo is a licensed Certified Public Accountant.

Ms. Ebersole has over 25 years of global strategic human resources experience. She most recently served as Chief Human Resources Officer at Paul Hastings LLP, leading the redesign of its compensation system and talent acquisition. Before joining Paul Hastings, she spent 18 years at Allergan, where she was Vice President, Human Resources, partnering with executives globally on key strategic initiatives in the Urology, Neurology, Dermatology, Ophthalmology, and Aesthetics business units. At Allergan, Ms. Ebersole led numerous commercial and R&D expansions, compensation planning, leadership development, and retention strategies. She received her B.S. in Business Administration from the University of Southern California’s Marshall School of Business and currently serves on the board of Big Brothers, Big Sisters of Orange County.

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron and over 2,350 individuals have received vibegron in past studies.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Urovant Sciences Initiates Phase 3 Clinical Program for Vibegron in Patients with Overactive Bladder

  • Pivotal trial will enroll approximately 1,400 patients for 12-week treatment period
  • Program supported by prior dosing in 2,350 subjects and positive Phase 2b and Phase 3 results

BASEL, Switzerland and IRVINE, Calif., March 28, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that it has initiated an international Phase 3 trial, EMPOWUR, to evaluate the safety and efficacy of vibegron, an investigational oral β3-adrenergic agonist, in adults with symptoms of overactive bladder.

“I am proud of our team’s efforts to rapidly launch this pivotal study for a promising therapy,” said Keith Katkin, Chief Executive Officer of Urovant. “Overactive bladder affects millions of individuals and patients need better alternatives to the current standard of care.”

Vibegron has been previously evaluated in 16 Phase 1 studies, one large international Phase 2b dose-ranging study in patients with overactive bladder, and a successful Phase 3 program in Japanese patients with overactive bladder.

About the Phase 3 Trial

The EMPOWUR study is a randomized, double-blind, placebo- and active comparator-controlled international Phase 3 clinical trial in men and women with symptoms of overactive bladder. The study is expected to enroll approximately 1,400 patients.

Individuals who meet eligibility requirements will be randomized to one of three groups for a 12-week treatment period: vibegron 75 mg administered orally once daily, placebo administered orally once daily, or tolterodine ER 4 mg administered orally once daily. Eligible patients completing the initial 12-week blinded assessment will be offered the opportunity to enroll in a 40-week double-blind extension study to evaluate the safety of longer-term treatment.

The co-primary efficacy endpoints of the study are:

  • Change from baseline in the average number of micturitions per 24 hours in all patients
  • Change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients with an average of ≥ 1 UUI episodes per day prior to treatment

Secondary endpoints will include changes in the frequency of incontinence episodes and urinary urgency episodes, and self-reported quality of life scores. Adverse events will be monitored during both the trial and the extension study.

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron and over 2,350 individuals have received vibegron in past studies.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Related Links

http://www.urovant.com

Urovant Sciences Announces Upcoming Presentations of Data from Phase 2b Trial of Vibegron in Patients with Overactive Bladder

  • Urovant Sciences, today announced that clinical data from a Phase 2b study of vibegron will be presented at two upcoming medical congresses.
  • Eight-week results from the vibegron dose-ranging trial will be presented at the 2018 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)

BASEL, Switzerland and IRVINE, Calif., February 28, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that clinical data from a Phase 2b study of vibegron will be presented at two upcoming medical congresses.

Eight-week results from the vibegron dose-ranging trial will be presented at the 2018 Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), which is being held February 27-March 3 in Austin, Texas. In addition, 52-week data from an extension of the same vibegron trial will be presented at the 113th Annual Meeting of the American Urological Association (AUA), which is being held May 18-21 in San Francisco, California.

Details for both presentations are as follows:

SUFU Oral Presentation

  • Date and Time: March 3, 2018 at 8:10 a.m. CT
  • Abstract (#34): Vibegron, a Novel Once Daily Oral β-3 Agonist, Significantly Reduces Average Daily Micturitions, Urge Incontinence Episodes and Urgency Episodes in Patients with Overactive Bladder
  • Location: Austin, Texas
  • Presenter: David Mitcheson

AUA Oral Presentation

  • Date and Time: May 20, 2018 at 3:30 p.m. PT
  • Abstract (#18-2878): Durable Efficacy and Safety of Long-Term Once-Daily Vibegron, A Novel Oral β-3 Adrenergic Receptor Agonist: A 52-Week Phase 2 Study in Patients with Overactive Bladder Symptoms
  • Location: San Francisco, California
  • Presenter: Roger Dmochowski

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Urovant Sciences Appoints Keith A. Katkin as CEO

  • Former CEO of Avanir Pharmaceuticals joins Roivant family of companies
  • Plans to initiate confirmatory Phase 3 program of vibegron by early 2018

BASEL, Switzerland, September 18, 2017 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced the appointment of Keith A. Katkin as Chief Executive Officer.

“I am excited to build Urovant into a leading company in the field of urology,” said Mr. Katkin. “Vibegron is a promising drug with strong Phase 2 and Phase 3 data. I look forward to rapidly advancing the development of vibegron including the initiation of a confirmatory Phase 3 pivotal trial in the months to come.”

“I’d like to extend a warm welcome to Keith,” said Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant Sciences. “His track record of building successful companies and his passion for delivering new medicines to patients makes me excited to see him take charge as the leader of one of our newest Vants.”

Mr. Katkin recently served as President and Chief Executive Officer of Avanir Pharmaceuticals from 2007 to 2016, where he oversaw the company’s sale to Otsuka Pharmaceutical Co., Ltd. Mr. Katkin joined Avanir in 2005 as Senior Vice President of Sales and Marketing and was responsible for developing and executing the corporate strategy that led to the approval and commercialization of NUEDEXTA.

Prior to Avanir, Mr. Katkin served as Vice President, Commercial Development for Peninsula Pharmaceuticals, Inc. where he played a key role in the concurrent initial public offering and sale of the company to Johnson and Johnson. Earlier in his career, Mr. Katkin held leadership roles at InterMune, Amgen, and Abbott Laboratories. Mr. Katkin earned his B.S. in Business and Accounting from Indiana University and his M.B.A. from the Anderson School at UCLA. He is a licensed Certified Public Accountant.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron (formerly MK-4618) from Merck. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

We advance our drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also plans to launch new companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit roivant.com.

Related Links

http://www.urovant.com

Roivant Sciences Launches Urovant to Develop Innovative Therapies in Urology

  • Urovant has licensed vibegron, a Phase 3-ready selective β3-adrenergic agonist for the treatment of overactive bladder, from Merck
  • Urovant plans to initiate a multinational Phase 3 registration program in 2017

BASEL, Switzerland, June 6, 2017 /PRNewswire/ — Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families, today announced the formation of Urovant Sciences, a new company focused on developing innovative therapies for urologic conditions.

Urovant’s lead therapeutic candidate is vibegron, an oral β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron (formerly MK-4618) from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

Over 2,700 patients with symptoms of overactive bladder have been enrolled in clinical studies evaluating the safety and efficacy of vibegron, including a completed global randomized, double-blind, placebo- and active comparator-controlled Phase 2b study of over 1,300 subjects that met its primary endpoints and key secondary endpoints, as well as a completed randomized, placebo and active comparator-controlled Phase 3 study of over 1,000 patients conducted outside of the United States that met its primary and key secondary endpoints. Urovant plans to initiate a multinational Phase 3 registration program for vibegron in 2017.

“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.”

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects potentially 46 million American adults. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for overactive bladder (OAB). β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead investigational drug is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder.

About Roivant Sciences

Roivant Sciences delivers R&D solutions to the biopharmaceutical industry and academic institutions through partnerships designed to realize the full potential of promising biomedical research. Roivant advances its drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant’s partners include Merck, Takeda Pharmaceuticals, GlaxoSmithKline, Eisai, Vertex Pharmaceuticals, Duke University, and Cincinnati Children’s Hospital Medical Center. Our long-range mission is to reduce the time and cost of developing new medicines for patients and to share those savings with the healthcare system.

Related Links

http://www.urovant.com

http://www.roivant.com

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