Many in Wall Street have been anxious, sitting on fire while waiting to learn, which biotech company Gilead Sciences (GILD) would decide upon acquiring that would deepen and enhance its pipeline. In Today’s news, a firm called Nimbus Therapeutics, LLC today announced that it has signed a definitive agreement under which terms Gilead will acquire Nimbus Apollo, Inc., a Nimbus Therapeutics wholly-owned subsidiary. Important is that the acquisition includes the firm’s Acetyl-CoA Carboxylase (ACC) inhibitor program. The cost, which is around $1.2 billion will be given in an upfront payment of $400 million and an additional $800 million in development-related milestones over time.
The Nimbus program includes the NDI-010976 — an ACC inhibitor, and other preclinical ACC inhibitors developed for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases.
That makes good sense, as it relates to the liver that Gilead’s HCV drugs have saved it from developing cirrhosis and cancer. The selection is probably based on the fact that the drug NDI-010976 was promising, which led the FDA to grant it Fast Track designation in February 2016. 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) where Gilead is now seen as the hero, saving millions of people from HCV complications that are debilitating, life-threatening, and cancer causing.
NASH is a serious liver disease known to cause liver dysfunction associated with steatosis (fat within the liver) that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis, almost similar to the complications of hepatitis C viral (HCV) infection that Gilead’s drugs are now preventing by curing the infection.
NASH is expected to become the leading indication for liver transplantation by 2020, a place now occupied with hepatitis C infection. NASH affects up to 15 million people in the United States.
The ACC inhibitors that Gilead grabbed target a central cause of the disease – reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis.
Gilead believes that 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. That what Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences said, “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.”
Upon completion of the acquisition, Nimbus Apollo will become a wholly-owned subsidiary of Gilead. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Gilead will be solely responsible for future development and commercialization of NDI-010976 and other ACC inhibitors.
Acetyl-CoA carboxylase (ACC) is an enzyme with two isoforms (ACC1 and ACC2) that is involved in de novo lipogenesis (the synthesis of endogenous fatty acids) and the regulation of beta-oxidation (the process by which fatty acids are broken down at a cellular level). Inhibitors of ACC therefore have the potential to prevent production of new lipids within the liver and stimulate their breakdown. In animal models of fatty liver, ACC inhibition reduces hepatic fat content, inflammation and fibrosis (scarring), all of which are important hallmarks of NASH progression. NDI-010976 is a potent, liver-targeted, allosteric inhibitor of both ACC isoforms.
To read about Nimbus Therapeutics go to the firm’s website at: http://www.nimbustx.com
This is a good selection and a good move by Gilead. But this is not the firm’s final move towards acquisitions. In addition to the fact that Gilead has a lot of cash ready to be invested, the firm’s management has a large amount of commonsense and wisdom and business orientations that make us believe this acquisition is not the last. We expect more acquisitions, especially in oncology and, probably in the area of neurodegenerative diseases. This area is vast and most of it is not yet revealed regarding the pathways of many known and unknown neurological diseases. Many well-diagnosed neurological diseases have yet to find treatments due to the lack of knowledge about their etiologies.