biospaceApril 25, 2018
Tag: Urovant , Vivek Ramaswamy
Urovant Sciences, one of biotech entrepreneur Vivek Ramaswamy "Vant" companies, has been busy the past few weeks. In March the company initiated a Phase III trial for an overactive bladder treatment, strengthened its management team and established a U.S. headquarters in Irvine, California.
This morning Urovant announced the location of its new headquarters but did not mention the size of the facility or how many employees would be operating from the new site. While little was said about the new headquarters, Urovant did provide information on its efforts to strengthen its senior leadership team during this pivotal time for its pipeline.
Urovant tapped five new executives, all with extensive history in the biotech industry. Cornelia Haag-Molkenteller, who most recently led Global Clinical Development for Women's Health, Internal Medicine, Anti-Infectives, and Urology at Allergan, has been named Urovant’s chief medical officer. Michael McFadden, the former commercial head at AVANIR Pharmaceuticals, was named chief commercial officer. Bryan Smith, a former counsel in Allergan’s urology division, was tapped as general counsel, Christine Ocampo was named chief accounting officer and Nori Ebersole was appointed to head human resources.
Keith Katkin, Urovant’s chief executive officer, praised the new members of his leadership team and said they will each contribute to the success of Urovant, which was launched last year.
"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," Katkin said in a statement.
Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB, a condition that affects as many as 46 million adults in the United States. When Urovant was launched in 2017 it licensed the drug from Merck Sharp & Dohme Corp., a subsidiary of pharma giant Merck & Co., Inc. When it was a Merck property vibegron had completed Phase II development and met its primary endpoints.
Urovant’s Phase III study will include both men and women who have symptoms of overactive bladder. Patients will be dosed for 12 weeks and researchers will be looking at two co-primary endpoints -- Change from baseline in the average number of micturitions (the urge to urinate) during a 24-hour period, and change from baseline in the average number of urge urinary incontinence during a 24-hour period.
β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating the β3 pathway, vibegron has the potential to relax the bladder detrusor muscle, which will allow a more efficient storage of urine and decrease the symptoms of overactive bladder. 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.
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