Date: 2016-11-10
Type of information: Licensing agreement
Compound: siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations including ND-L02-s0201
Company: BMS (USA - NY) Nitto Denko (Japan)
Therapeutic area: Liver diseases - Hepatic diseases - Fibrotic diseases
Type agreement: licensing development commercialisation
Action mechanism: siRNA. 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 5-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 HCV.
Disease: NASH (non-alcoholic steatohepatitis), lung fibrosis and other organ fibrosis
Details: * On November 10, 2016, BMS and Nitto Denko announced the companies have entered into an agreement granting BMS exclusive worldwide rights for the development and commercialization of Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A containing formulations. This agreement includes Nitto’s lead asset ND-L02-s0201, currently in Phase 1b study for the treatment of advanced liver fibrosis. It 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.
Financial terms: 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.
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