Gilead Sciences has signed a definitive agreement to acquire Nimbus Apollo, a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, an ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. NDI-010976 was granted Fast Track designation by the FDA in February 2016.

NASH is a serious liver disease resulting from metabolic dysfunction associated with steatosis (fat within the liver) that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. Affecting up to 15 million people in the U.S., NASH is expected to become the leading indication for liver transplantation by 2020. ACC inhibitors target a central cause of the disease—reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis.

“The acquisition of Nimbus’ ACC-inhibitor program represents a timely and important opportunity to accelerate Gilead’s ongoing efforts to address unmet needs in NASH,” said Norbert Bischofberger, Ph.D., executive vice president, R&D, and chief scientific officer, Gilead Sciences. “These molecules will complement and further strengthen Gilead’s pipeline and capabilities to advance a broad clinical program in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease.”

“Given the company’s long-standing commitment to and expertise in liver disease, we are confident that Gilead is the ideal partner to accelerate and maximize the potential of the ACC inhibitor program,” said Don Nicholson, Ph.D., chief executive officer of Nimbus Therapeutics. “This agreement underscores Nimbus’ ability to rapidly discover, design and optimize promising therapeutics in areas of unmet need, an approach we will continue to apply against other medically important targets.”

Upon completion of the acquisition, Nimbus Apollo will become a wholly-owned subsidiary of Gilead. Nimbus Therapeutics will retain ownership of its other R&D subsidiaries. Gilead will be solely responsible for future development and commercialization of NDI-010976 and other ACC inhibitors.