Roivant Acquires SB742457 from GlaxoSmithKline
Roivant Neurosciences Ltd has entered into an agreement with GlaxoSmithKline (GSK) for the acquisition of SB742457, a selective 5-HT6 receptor antagonist with the potential to improve cognition and function in multiple central nervous system disorders. GSK conducted thirteen clinical studies of SB742457 involving over 1250 healthy subjects and Alzheimer's disease patients. The results of these studies provide strong evidence that SB742457 holds promise for patients with mild-to-moderate Alzheimer's disease.
"This transaction represents a foundational late-stage clinical asset for Roivant," stated Vivek Ramaswamy, Founder and Director of Roivant Sciences Ltd. and CEO of Roivant Sciences, Inc. "Our organization is fully committed to building on the research already completed by GSK and advancing a new therapeutic option for Alzheimer's disease, a debilitating and deadly disease that affects millions of patients and their families."
Roivant intends to meet with the FDA in the first half of 2015 to confirm the regulatory requirements for the continued development of SB742457 for the treatment of the signs and symptoms of mild-to-moderate Alzheimer's disease. Roivant may also explore the clinical development of SB742457 for other neurological disorders for which there are limited or no therapeutic options.
"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," stated Dr Lawrence Friedhoff, Senior Vice President, Research & Development of Roivant Sciences, Inc. and the development team leader for Aricept (donepezil hydrochloride), the drug most commonly used for the treatment of Alzheimer's disease. "As we advance SB742457 into Phase III pivotal studies in 2015, we hope and expect that these clinical trials will support the approval of a new therapeutic option for patients."
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance