BMS agrees $100m liver drug deal with Nitto

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The liver is a vital organ of the digestive system present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion.

Bristol-Myers Squibb has signed an $100 million agreement with Japan’s Nitto Denko Corporation to develop an RNA silencing technology for liver cirrhosis due to advanced non-alcoholic steatohepatitis (NASH).

Several other big pharma companies, including Gilead and Shire, are chasing treatments for NASH - a disease where the liver becomes damaged due to a build-up of fat for which there are no approved treatments.

The agreement gives BMS exclusive worldwide rights to develop and market Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations.

This include Nitto’s lead asset, ND-L02-s0201, in phase 1b development for treatment of advanced liver fibrosis.

Nitto’s lead product, ND-L02-s0201, is a targeted siRNA therapy that is designed to inhibit HSP47, a collagen specific chaperone which regulates collagen synthesis and secretion, and prevent further collagen deposition as well as enable resolution of existing fibrosis.

Nitto is currently conducting a five-week open-label phase 1b study in patients with advanced fibrosis (F3-F4c) due to NASH or hepatitis C.

The FDA granted fast track designation to ND-L02-s0201 for two indications, liver fibrosis and cirrhosis secondary to NASH and liver fibrosis and cirrhosis secondary to hepatitis C infection.

BMS will make an upfront payment of $100m to Nitto, and will be responsible for development, manufacture and marketing of HSP47 siRNAs in vitamin A containing formulations, for all liver diseases.

Nitto is also eligible for clinical and regulatory milestone payments, royalties, sales based milestone payments, as well as option exercise payments for lung and other organ fibrosis.

Several other companies are competing to develop treatments for NASH – in April Gilead paid $1.2 billion for Nimbus Therapeutics’ liver drug subsidiary, which is also developing a NASH treatment.

Allergan in September bought two biotechs developing NASH drugs, Tobira and Akarna.

The FDA has fast-tracked Shire’s early stage NASH drug, volixibat, and Intercept has obeticholic acid, already approved in another liver disease, in phase 3b development for NASH.