Gilead Sciences and Yuhan Corporation have entered into a licensing and collaboration agreement to co-develop novel therapeutic candidates for the treatment of patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH).

Under the agreement, Gilead will acquire global rights to develop and commercialize novel small molecules against two undisclosed targets in all countries, with the exception of the Republic of Korea where Yuhan will retain certain commercialization rights. Yuhan and Gilead will jointly conduct preclinical research, and Gilead will be responsible for global clinical development. Gilead will also be responsible for commercialization worldwide, outside of Yuhan’s rights in the Republic of Korea. 

In connection with this agreement, Yuhan will receive an upfront payment of $15 million and is eligible to receive up to an additional $770 million in potential milestone payments upon achievement of certain development and commercial milestones, as well as royalties on future net sales. This agreement builds on the companies’ existing commercial collaboration to support the promotion of Gilead’s medicines in the Republic of Korea.

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals with advanced fibrosis due to NASH, defined as bridging fibrosis (F3) or cirrhosis (F4), may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality. 

“This collaboration builds on our long-term partnership with Yuhan, with a new focus on the investigation of novel approaches to treat patients with advanced fibrosis due to NASH that complement our ongoing research programs,” said John McHutchison, MD, AO, chief scientific officer and head of Research and Development, Gilead Sciences. “We look forward to working with the Yuhan team to advance our work in this area where there is a significant unmet need for patients.”

“I am very pleased by this collaboration, which significantly expands and deepens our longstanding, trusted partnership with Gilead. We are confident that Gilead’s expertise in liver disease will accelerate the development of our novel agents. As a company, we are committed to investigating new therapeutics to improve the lives of patients with NASH,” said Mr. Jung Hee Lee, president and chief executive officer of Yuhan.