Novartis partners with Conatus on new oral treatments for chronic liver diseases

The companies signed an exclusive option, collaboration and license agreement for the worldwide development and commercialization of Conatus’ emricasan, an investigational oral, pan-caspase inhibitor intended to treat non-alcoholic steatohepatitis (NASH) with advanced fibrosis (scarring) and cirrhosis.

The collaboration has the potential to extend treatment options for people in several stages of fatty liver disease, where there are no approved medicines at present.

Under the deal, Conatus will receive $50m upfront payment from Novartis. The US firm is also eligible to receive $7m after the exercise of the license option.

Conatus will be allowed to borrow around $15m in convertible promissory notes as per an investment agreement with Novartis.

Apart from the upfront payment, Conatus is eligible to receive significant payments for several development, regulatory and commercial milestones, and would get tiered double-digit royalties on emricasan single-agent sales and tiered single- to double-digit royalties on sales of combination products featuring emricasan.

Conatus has the option to co-commercialize emricasan in the US. Novartis has also agreed to pay 50% of Conatus' phase 2b emricasan development costs after the option exercise, including the proposed ENCORE-LF trial in decompensated NASH cirrhosis.

Novartis is developing Farnesoid X receptor (FXR) agonists to treat chronic liver diseases.

As part of the collaboration, Conatus will carry out several phase 2b clinical trials with emricasan in NASH.

If successful, Novartis would then undertake phase 3 studies of emricasan as a single treatment and start development of combination therapies with an FXR agonist.

Novartis global head of drug development and chief medical officer Vasant Narasimhan said: "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.

"Emricasan shows great promise as a single agent and in potential combination with our internal FXR agonists as a treatment for NASH patients.”

Image: Novartis Logo, Basel Headquarters. Photo: courtesy of Novartis AG.