Bristol-Myers pens $100M NASH, fibrosis drug deal with Japan’s Nitto

Bristol-Myers Squibb is beefing up its fast-growing fibrosis portfolio after paying $100 million upfront to Japanese biopharma Nitto to develop and sell its early-stage liver-scarring candidate--as well as an option to buy into other antifibrotic meds.

Under the deal, BMS gains exclusive worldwide rights to Nitto’s investigational siRNA molecules targeting heat shock protein 47 (HSP47) in vitamin A-containing formulations--which includes Nitto’s lead asset ND-L02-s0201, currently in Phase Ib for advanced liver fibrosis due to nonalcoholic fatty liver disease, or NASH, as well as scarring due to hep C infection.

The deal also allows the U.S. Big Pharma a choice to take exclusive licenses for HSP47 siRNAs in vitamin A containing formulations for the treatment of lung fibrosis and other organ fibrosis.

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“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, MB BChir, FRCP, EVP and chief scientific officer of Bristol-Myers.  

“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 and cirrhosis due to NASH who currently have limited treatment options.”

Hideo Takasaki, chief executive officer of Nitto, added: “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.”

Antifibrotic research--especially in NASH that has no approved meds but is estimated to affect tens of millions of Americans--has become a major R&D theme for Big Pharma and biotech alike in recent years, with host of biopharmas such as Intercept Pharmaceuticals ($ICPT), Gilead ($GILD), Genfit and others all vying for a major blockbuster market.

Bristol also follows moves from Allergan ($AGN) in recent months that has seen it buy two NASH-focused biotechs as it too tries to get in on the race to market.

There already two meds on the market for IPF in the form of Roche’s ($RHHBY) Esbriet (pirfenidone) and Boehringer’s Ofev (nintedanib).

Nitto’s lead product, ND-L02-s0201, works by regulating collagen synthesis and secretion, and prevent further collagen deposition as well as enable resolution of existing fibrosis.

Nitto is currently working on a 5-week open-label Phase Ib study in patients with advanced fibrosis (F3-F4c) due to NASH or hepatitis C. The drug already enjoys an FDA fast-track tag in two indications: liver fibrosis and cirrhosis secondary to NASH, and liver fibrosis and cirrhosis secondary to HCV.

As well as the $100 million upfront, Nitto can also look forward to more biobucks should its med do well in testing, as well as an option to exercise payments for lung and other organ fibrosis. Further financial details weren’t disclosed.

This deal will help complement BMS’s burgeoning fibrosis portfolio, which includes its midstage NASH med PEG-FGF21, a recombinant version of human fibroblast growth factor 21.

The pharma also has an exclusive right to buy out Lexington, MA-based biotech Promedior and its candidate PRM-151, a recombinant form of human pentraxin-2 protein, which is currently in Phase II for IPF and MF. The deal is worth up to $1.25 billion.

On top of this, it has a buyout pact for Denmark’s Galecto, agreeing to pay up to $444 million for the co and its TD139, an inhibitor of galectin-3, which binds to carbohydrate structures.

Bristol also has a research collab with the Medical University of South Carolina, struck back in July 2015, which is focused on fibrotic diseases, including scleroderma, renal fibrosis and IPF.