Bristol-Myers Squibb Obtains Rights to Antifibrotic siRNA Drug Development Program

Bristol-Myers Squibb has acquired exclusive worldwide rights to Nitto Denko’s antifibrotic drug development efforts with siRNA molecules. In addition to the Japanese company’s lead compound ND-L02-s0201, currently in a Phase 1b clinical trial (NCT02227459) for advanced liver fibrosis, the agreement gives Bristol-Myers the right to obtain licenses for other compounds developed from this line of siRNA molecules in vitamin A-containing formulations, including drugs for lung fibrosis.

Nitto Denko’s siRNA molecules target HSP47 (heat shock protein 47) — a protein that controls collagen synthesis and secretion. Studies have shown that the compounds can prevent further collagen deposits while also working to resolve existing fibrosis.

“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,” Hideo Takasaki, chief executive officer of Nitto Denko, said in a press release.

“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,” added Takasaki.

The agreement, which was cleared by Hart-Scott-Rodino Antitrust Improvements Act, obliges Bristol-Myers Squibb to make an upfront payment of $100 million to Nitto. Bristol-Myers will then be in charge of the development, manufacture, and commercialization of HSP47 siRNAs in vitamin A-containing drugs for all liver diseases.

Nitto is also eligible to receive later payments linked to development and commercialization milestones, as well as option exercise payments for lung and other organ fibrosis.

“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,” said Francis Cuss, executive vice president and chief scientific officer of Bristol-Myers Squibb.

“We continue to invest in innovative approaches both internally and externally that may halt or slow the progression of fibrotic diseases and are pleased to partner with Nitto Denko to advance the development of therapies for patients living with advanced NASH [non-alcoholic steatohepatitis] and cirrhosis due to NASH who currently have limited treatment options,” Cuss added.