- Bristol-Myers Squibb and Nordic Bioscience, a Danish biotech, announced April 17 a partnership aimed at developing new biomarkers for the diagnosis and monitoring of fibrotic diseases, most notably for the difficult-to-detect non-alcoholic steatohepatitis (NASH).
- Sometimes called a "silent" illness, NASH is a form of fatty liver disease characterized by inflammation and scarring that can lead to cirrhosis or liver failure. Nearly 20,000 Americans died from chronic liver disease or cirrhosis not related to alcoholism in 2014, the most recent year for which the Centers for Disease Control and Prevention has complete data.
- Drugmakers see the market for NASH treatments as a potentially lucrative opportunity, given the growing prevalence of the condition and lack of existing pharmacological treatment. But diagnosis can be challenging and involved, upping the need for a simpler test like a validated biomarker.
The past year has seen an explosion of activity in the NASH space. Gilead, Allergan and Novartis have all made acquisitions to build out and accelerate development pipelines of clinical candidates.
Allergan, in particular, has bet heavily on NASH, paying a eyebrow-raising premium to pick up Tobira Therapeutics in a September 2016 deal which could be worth up to $1.7 billion. The same day Allergan announced the Tobira acquisition, the Irish pharma also snapped up privately held Akarna Therapeutics for $50 million upfront.
In addition to the big pharma players, Intercept Pharmaceuticals and the French drugmaker Genfit SA are in mid- to late-stage clinical testing of their respective NASH candidates.
Bristol-Myers and Nordic Bioscience plan to collaborate on the development of translational biomarkers and diagnostics to help evaluate NASH in pre-clinical models as well as clinical settings. The deal could help Bristol-Myers advance development of its fibrotic diseases pipeline, one of the three core therapeutic areas for the Indianapolis drugmaker outside of oncology.
According to data cited by the National Institute of Diabetes and Digestive and Kidney Diseases, between 3% and 12% of adults in the U.S. have NASH — a wide range that reflects the challenges with diagnosis.
Elevated liver enzyme counts can be a sign of NASH and ultrasound scans can help detect the trademark fat build up in the liver. Invasive liver biopsies, though, are the only way to absolutely confirm a diagnosis.
"There is a big unmet need in medical and drug development for simple non-invasive diagnostic, early proof of efficacy of intervention and prognostic biomarkers in the NASH field," said Morten Karsdal, CEO of Nordic Bioscience
Biomarkers, despite their promise as potent tools to diagnosis and segment disease populations in both testing and treatment, have failed Bristol-Myers before.
A damaging and surprising miss in a Phase 3 study of Opdivo last summer was widely attributed to Bristol-Myers decision to include a broader patient population as measured by PD-L1 expression. While biomarkers can give insight into which patients are most likely to respond, defining thresholds can be an elusive task — as Bristol-Myers found out with Checkmate-026.
Editor's note: In a previous version of this article, two sentences incorrectly identified Bristol-Myers Squibb's partner in the collaboration. Bristol-Myers Squibb and Nordic Bioscience, not Bavarian Nordic, are collaborating on developing biomarker technology.