Novartis takes option on NASH drug from Conatus
Novartis has signalled its strong intentions in the race to develop a treatment for the fatty liver disease, non-alcoholic steatohepatitis (NASH), taking an option on Conatus Pharmaceuticals' emricasan.
The Swiss pharma giant paid $50 million up front in a licensing deal for Conatus’ Farnesoid X receptor (FXR) agonist late last year.
Since then it has signed a deal to develop FXR agonists in combination with Allergan in NASH – a disease for which there is no approved treatment that is a target for other pharma companies including Shire and Gilead.
The $7 million option gives Novartis an exclusive licence for the global development and marketing of emricasan under the terms of the agreement signed with Conatus in December.
Conatus began a phase 2b trial evaluating emricasan in patients with decompensated liver cirrhosis caused by NASH.
But the collaboration could expand research into the drug in people in various stages of NASH.
Conatus will conduct phase 2b clinical trials with emricasan in NASH and if results are positive, Novartis will conduct phase 3 studies of the drug as a single treatment as well as in combination with other therapies.
FXR agonists reduce fat, inflammation and fibrosis in the liver – three of the most important aspects of NASH.
Novartis’ most advanced FXR agonists, are non-bile acid drugs and are in phase 2 clinical trials. Both have received Fast Track designation from the FDA for NASH with liver fibrosis.
The FDA has also given emricasan a Fast Track designation, reserved for promising new treatments for serious diseases, allowing for regulatory support and potentially a faster, six-month review at the end of development.
Although no drugs have been approved for NASH, the market for treatments is expected to grow to between $25 billion and $30 billion, driven by poor diets and sedentary lifestyles
However Intercept’s Ocaliva (obeticholic acid) gained approval for a similar liver condition, primary biliary cholangitis (PBC) last year.
Intercept's Ocaliva and Genfit's Elafibranor, both in phase 3 trials for NASH, are front-runners in the race. However both have encountered issues recruiting patients to their trials in recent weeks, leaving the field still open.