Nitto Denko has granted Bristol-Myers Squibb (BMS) an exclusive license to develop its lead asset, the Phase Ib advanced nonalcoholic steatohepatitis (NASH) candidate ND-L02-s0201, and other smalll interfering RNA (siRNA) molecules targeting heat shock protein 47 (HSP47) in vitamin A-containing formulations, the companies said today.
ND-L02-s0201 is the subject of a 5-week, open-label Phase Ib study in patients with advanced liver fibrosis (F3-F4 compensated) due to NASH or hepatitis C virus (HCV).
“Addressing the significant unmet need in fibrotic diseases is a key part of Bristol-Myers Squibb’s strategy to build a sustainable and diversified portfolio of transformational medicines,” Francis Cuss, M.B. B.Chir., FRCP, evp and CSO for BMS, said in a statement. “We continue to invest in innovative approaches both internally and externally that may halt or slow the progression of fibrotic diseases.”
Fibrosis has been an area of strategic focus for BMS. As of October 1, according to its website, BMS’ fibrosis pipeline was led by three Phase II candidates—PEG-FGF21 (pegylated human fibroblast growth factor 21), licensed by the pharma from Ambrx in 2011; a recombinant human pentraxin-2 protein candidate for idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF) that BMS acquired last year for up to $1.25 billion; and BMS-986020, a small-molecule lysophosphatidic acid 1 (LPA1) receptor antagonist.
Under the licensing agreement, the companies said, BMS has been granted the option to receive exclusive licenses for HSP47 siRNAs in vitamin A-containing formulations to treat lung fibrosis and other organ fibrosis.
BMS has agreed to oversee development, manufacture, and commercialization of HSP47 siRNAs in vitamin A-containing formulations for all liver diseases. In return, BMS has agreed to pay Nitto Denko $100 million upfront, as well as payments tied to achieving clinical, regulatory, and sales milestones, plus royalties, and option exercise payments for lung and other organ fibrosis.
The FDA has granted fast track designation to ND-L02-s0201 for liver fibrosis and cirrhosis secondary to NASH and liver fibrosis and cirrhosis secondary to HCV.
The license agreement is subject to clearance under the Hart–Scott–Rodino Antitrust Improvements Act, BMS and Nitto Denko added.