Roivant Neurosciences Acquires GSK’s Novel Neurological Disorder Treatment

Roivant Neurosciences, a biopharmaceutical company focused on late-stage clinical development and commercialization of non-strategic, de-prioritized, or under-resourced drug candidates, announced on Dec. 23, 2014 that it entered into an agreement with GlaxoSmithKline (GSK) to acquire SB742457, a selective 5-HTC receptor antagonist for oral treatment in patients with mild-to-moderate Alzheimer’s disease (AD). The acquisition adds to Roivant’s neurologic pipeline, a pipeline that also includes hepatology, oncology, pulmonology, gene therapy, and rare diseases.

Prior to the acquisition, GSK conducted 13 clinical studies with more than 1250 healthy patients and patients with AD. Preliminary preclinical data suggest a potential additive or synergistic effect when 5-HTC antagonists are added to acetylcholinesterase inhibitors, which is one of the two classes of drugs approved by FDA for the treatment of AD. According to a press release, the studies provided “strong evidence that SB742457 holds promise for patients with mild-to-moderate Alzheimer’s disease.”

"Despite the large number of clinical trials in Alzheimer's disease and related disorders during the past decade, there have been no new drugs approved in that period. As we advance SB742457 into Phase 3 pivotal studies in 2015, we hope and expect that these clinical trials will support the approval of a new therapeutic option for patients,” said Lawrence Friedhoff, MD, PhD, senior vice president, research and development at Roivant Sciences, Inc. and the development team leader for Aricept (donepezil hydrochloride), the drug most commonly used for the treatment of AD.

Roviant expects to meet with FDA in early 2015 to discuss regulatory requirements to continue development of SB742457, and may explore the clinical development of the drug for other neurological disorders that have limited or no therapeutic options. The financial details of the acquisition were not disclosed.

Sources:
RoivantGSK