Bristol-Myers Squibb (BMS) has entered into an agreement with Nitto Denko Corporation, an Osaka, Japan-based materials manufacturer, which grants BMS exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules. These siRNA molecules target heat-shock protein 47 (HSP47) in vitamin A-containing formulations, including Nitto’s lead asset, ND-L02-s0201, currently in a Phase Ib study for treating advanced liver fibrosis.

The agreement also grants BMS the option to receive exclusive licenses for HSP47 siRNAs in vitamin A- containing formulations for treating lung fibrosis and other organ fibrosis. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Under the agreement, BMS will make an upfront payment of $100 million to Nitto. BMS will be responsible for the development, manufacture, and commercialization of HSP47 siRNAs in vitamin A-containing formulations for all liver diseases. Nitto is also eligible to receive subsequent clinical and regulatory milestone payments, royalties, and sales-based milestone payments as well as option-exercise payments for lung and other organ fibrosis.

Nitto’s lead product, ND-L02-s0201, is a targeted siRNA therapy that is designed to inhibit HSP47, a collagen-specific chaperone that regulates collagen synthesis and secretion. The US Food and Drug Administration has granted fast track designation to ND-L02-s0201 for two indications: liver fibrosis and cirrhosis secondary to non-alcoholic steatohepatitis and liver fibrosis and cirrhosis secondary to hepatitis C virus.

Source: Bristol-Myers Squibb