BMS Enters into License Agreement for NASH Drug

On Nov. 10, 2016, Bristol-Myers Squibb (BMS) entered into a license agreement with Nitto Denko Corporation, a Japanese materials manufacturer, for Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47). This list of molecules includes Nitto’s lead asset ND-L02-s0201, currently in Phase Ib study for the treatment of advanced liver fibrosis. The agreement also grants BMS the option to receive exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis 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, prevents further collagen deposition, and enables 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 non-alcoholic steatohepatitis

(NASH) or hepatitis C. 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.

“We believe our investigational anti-fibrosis drug has the potential to make a significant contribution to help patients with advanced liver fibrosis. We are very excited that Bristol-Myers Squibb joins our effort, as this will provide an accelerated development for this compound,” said Hideo Takasaki, CEO, Nitto Denko Corporation in a statement. “From now on, Nitto group will support Bristol-Myers Squibb for further development and will continue our efforts to develop other organ fibrosis treatments including Idiopathic Pulmonary Fibrosis (IPF) through our newly established Nitto BioPharma Inc.”

Under the terms of 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, sales-based milestone payments as well as option exercise payments for lung and other organ fibrosis.

Source: Bristol-Myers Squibb