Gilead surprises with $1.2 bn move for Nimbus Apollo liver drug firm

Gilead is to buy Nimbus Therapeutics’ liver drug subsidiary in a deal worth up to $1.2 billion as it aims to build on the success of its hepatitis C franchise.

The Nimbus Apollo deal is small compared with the $11 billion paid for Pharmasset in 2011, which landed Gilead with its huge selling hepatitis C drug, Sovaldi (sofosbuvir), leaving the market in shock with its sheer audacity.

But once again Gilead has sprung a surprise as the California-based pharma had been tipped to buy Intercept, a company working in the same field.

Nimbus Apollo is a wholly-owned subsidiary of Massachusetts-based Nimbus Therapeutics and specialises in developing acetyl-CoA carboxylase (ACC) inhibitors.

Its lead drug is NDI-010976, an ACC inhibitor, for non-alcoholic steatohepatitis (NASH), hepatocellular carcinoma and other diseases. It also has several preclinical drug candidates.

Phase 1 data will not be published until next month but the drug has been given “fast track” designation by the US Food and Drug Administration.

Nimbus will receive an upfront payment of $400 million and could receive up to $800 million in development-related milestone payments.

Upon completion, 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 commercialisation of NDI-010976 and other ACC inhibitors.

Intercept’s liver drug, obeticholic acid, is much further advanced at Phase 3 but there are question marks about its future after it failed in a phase 2 NASH trial in Japan.

Gilead’s decision is also notable considering that US Food and Drug Administration advisers are to meet and discuss obeticholic acid as a treatment for primary billary cirrhosis on Thursday.

A recommendation from the Gastrointestinal Drugs Advisory Committee is not binding, but will certainly influence whether the FDA decides to approve the drug in May. The FDA put back a decision date back from 29 February to 20 May, as although it had granted a fast review the regulator required additional data analyses.

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 United States, 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.

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