Novartis announced the signing of an exclusive option, collaboration and license agreement with Conatus Pharmaceuticals Inc., a biotechnology company focused on the development of novel medicines to treat liver disease. This agreement will enable Novartis and Conatus to jointly develop emricasan. Emricasan is an investigational, first-in-class, oral, pan-caspase inhibitor for the treatment of 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.
Under the terms of this agreement, Novartis will make an upfront payment to Conatus of USD 50 million. Any additional exercise fee will be paid to Conatus following achievement of certain criteria as defined in the option, collaboration and license agreement, including required anti-trust approvals.
"Our collaboration with Conatus is a major step forward to delivering innovative oral treatments for NASH patients, who are in urgent need of new approved options," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Emricasan shows great promise as a single agent and in potential combination with our internal FXR agonists as a treatment for NASH patients".
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 2b clinical trials with emricasan in NASH. If concluded positively, Novartis would then conduct Phase 3 studies of emricasan as a single treatment and start 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. The most advanced Novartis investigational compound, a potent, non-bile acid FXR agonist, has recently received Fast Track designation from the US Food and Drug Administration (FDA) for NASH with liver fibrosis and is in a Phase 2 clinical trial.
NASH is a common, often silent liver disease; the major feature of which is fat in the liver, along with inflammation and scarring. Around 3-5% of the US population is affected with NASH, which is set to become the leading cause of liver transplants in the US by 2020.