Memorandum

Novartis announced collaboration with Conatus Pharmaceuticals to develop phase 2 oral pan-capase inhibitor emricasan for NASH – December 20, 2016

Yesterday, Novartis announced an exclusive option and licensing agreement with Conatus Pharmaceuticals for phase 2 oral pan-capase inhibitor emricasan for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis and cirrhosis of the liver. Under the terms of the agreement, Conatus will receive a $50 million upfront payment from Novartis and Conatus will oversee phase 2b studies of emricasan. Contingent on positive results, Novartis will then be responsible for the phase 3 development program, with planned trials investigating emricasan as monotherapy for NASH and in combination with FXR agonists (of which Novartis has several in various stages of clinical development). For Novartis, this collaboration represents a significant increased investment in NASH, a common comorbidity of type 2 diabetes and obesity and an area of tremendous unmet need – no therapies are yet approved for the treatment of NASH. We’re very excited to see this continued trend of major pharmaceutical companies stepping up their investment in NASH: Allergan recently acquired Tobira Therapeutics and Akarna Therapeutics, and its NASH pipeline candidates include DPP-4 inhibitor evogliptin, CCR2/CCR5 inhibitor cenicriviroc, and FXR agonist AKN-083. Novo Nordisk announced its intention to focus on innovation for NASH and other diabetes-adjacent conditions during the company’s 3Q16 update, which includes GLP-1 agonist semaglutide in phase 2 for NASH. We’re certainly happy to see this commitment from big players in drug development – NASH has remained a critical area of unmet need for far too long, and we hope therapeutic options will soon emerge from the increasingly robust competitive landscape. We look forward to following emricasan’s progress through clinical development, and we’re eager to learn more details about the trial design and timeline of phase 2b and phase 3 studies. See our updated NASH competitive landscape for an overview of other pharmacotherapies in development for this diabetes comorbidity.

-- by Payal Marathe, Abigail Dove, Helen Gao, and Kelly Close