Novartis Exercises Option for Liver-Disease Drug
Novartis has exercised its option for an exclusive license with Conatus Pharmaceuticals, a biopharmaceutical company, for the global development and commercialization of emricasan, a drug candidate to treat liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).
Under the option, collaboration, and license agreement signed with Conatus in December 2016, the exercise of the option with Conatus is effective upon receipt of all required antitrust approvals and payment of a $7-million option exercise fee by Novartis to Conatus.
Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases. As part of this collaboration, Conatus will conduct multiple Phase IIb clinical trials with emricasan in NASH. If results are positive, Novartis would then conduct Phase III studies of emricasan as a single treatment as well as development of combination therapies with an FXR agonist.
FXR agonists have been shown to address three of the most important aspects of NASH progression by reducing fat, inflammation, and fibrosis in the liver, according to information from Novartis. The most advanced Novartis investigational compounds, both non-bile acid FXR agonists, are in Phase II clinical trials. Both of these FXR agonists have received fast-track designation from the US Food and Drug Administration (FDA) for NASH with liver fibrosis. In addition, the FDA has granted fast-track designation for the development of emricasan in patients with NASH cirrhosis.
Recently, Novartis announced a clinical collaboration with Allergan to conduct a Phase IIb study, involving the combination of a Novartis FXR agonist and Allergan’s cenicriviroc for the treatment of NASH with liver fibrosis.