April 4, 2016
By Alex Keown, BioSpace.com Breaking News Staff
FOSTER CITY, Calif. – Gilead Sciences struck a $1.2 billion deal to acquire Cambridge, Mass.-based Nimbus Apollo, Inc. for its Acetyl-CoA Carboxylase (ACC) inhibitor program in an effort to bolster the company’s pipeline for metabolic disorders and the treatment of non-alcoholic steatohepatitis (NASH).
Under the terms of the deal, Nimbus will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time. Nimbus Apollo, Inc. is a subsidiary of Nimbus Therapeutics, LLC.
Gilead has long been expected to strike a deal to bolster its pipeline through M&A activity in large part due to expectations that its revenue growth from its blockbuster hepatitis treatments are expected to remain fairly flat. Harvoni and Sovaldi generated revenue of $20 billion in 2015. In February, Gilead’s Chief Executive John Miligan said he was eying some growth opportunities, particularly in the oncology, inflammatory diseases and liver disease fields.
With the deal, Gilead will acquire the Nimbus Apollo program that 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 U.S. Food and Drug Administration (FDA) in February 2016 and Phase 1 data for the compound will be presented next month during an oral session at The International Liver Congress 2016, the annual meeting of the European Association for the Study of the Liver (EASL), the company said in a statement.
Non-alcoholic steatohepatitis affects approximately 15 million people in the United States. NASH is a disease of the liver resulting from fat cells that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. ACC inhibitors target a central cause of the disease—reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis. Gilead said NASH is expected to become the leading indication for liver transplantation by 2020.
The addition of NDI-010976 will back up NASH research Gilead is conducting with its investigational monoclonal antibody simtuzumab, which was acquired from Arresto Biosciences in 2011. Gilead’s simtuzumab has had something of a troubled history, with the company ceasing several drug trials for various disorders.
“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,” Norbert Bischofberger, Gilead’s executive vice president of Research and Development and Chief Scientific Officer, said in a statement. “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.”
Writing in Forbes, Bruce Booth of Atlas Ventures, one of the lead investors in Nimbus, called the ACC inhibitor an ideal target for treatment of NASH. Inhibiting ACC is expected to shut down the body’s production of excessive lipid levels, which would lead to reductions in fat levels that cause the inflammation associated with NASH, Booth said.
“In addition, ACC has real potential in areas like diabetes, obesity, inflammatory disease, cancer metabolism, and lipid-related disorders,” Booth said in his column.
Other companies are also developing treatments for NASH. In 2015, San Diego-based startup Metacrine, Inc. launched with goals of developing treatments for NASH and other liver disorders. Although the company has remained tight-lipped about its approaches, its therapies are armed with a therapy acquired from the Salk Institute.
Gilead is looking to bolster its drug offerings beyond its dominance in the hepatitis C market with its blockbuster drugs Harvoni and Sovaldi, particularly after a court ruled earlier this year that the drugs infringed on patents owned by Merck .
