Novartis in Liver-Disease Drug Pact

Novartis has entered into an exclusive option, collaboration and license agreement with Conatus Pharmaceuticals, a San Diego-based biotechnology company focused on liver-disease therapies, to jointly develop emricasan, an investigational drug for treating liver disease.

Under the agreement, Novartis will make a $50-million upfront payment to Conatus. Any additional exercise fee will be paid to Conatus following achievement of certain criteria as defined in the agreement, including required anti-trust approvals.

Emricasan is an investigational, oral, pan-caspase inhibitor in development to treat non-alcoholic steatohepatitis (NASH) with advanced fibrosis (scarring) and cirrhosis. This collaboration has the potential to expand treatment options for people in various stages of fatty liver disease, where no approved medicines currently exist.

As part of this collaboration, Conatus will conduct multiple Phase IIb clinical trials with emricasan in NASH. If concluded positively, Novartis would then conduct Phase III studies of emricasan as a single treatment and start development of combination therapies with a farnesoid X receptor (FXR) agonist. Novartis is separately developing FXR agonists to treat chronic liver diseases.

FXR agonists have been shown to address three aspects of NASH progression by reducing fat, inflammation, and fibrosis in the liver, according to Novartis. Novartis’ lead investigational compound, currently in Phase II development, is a non-bile acid FXR agonist, which has recently received fast track designation from the US Food and Drug Administration for NASH with liver fibrosis.

Source: Novartis

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