New York/Basil — Pfizer and Novartis have been independently developing therapies for nonalcoholic steatohepatitis (NASH), and they’re now set to join forces to yield a combination therapy for the fatty liver disease linked closely with metabolic disorders.
NASH is characterized by liver inflammation and cell damage. Potentially fatal, it’s growing more and more common among people suffering from obesity or type II diabetes and, over the next couple of years, it’s likely to become the leading reason for liver transplants. There are currently no approved medications for the disease, though doctors recommend dieting and exercise.
Valued at $35 billion by some estimates, the burgeoning NASH market has spurred attempts at pharmaceutical development for some time. For example, in just the last few years, Shire, GenFit, and Intercept have all worked toward NASH therapies but encountered setbacks in trials. It’s a complex condition, but an innovative one-two punch from a couple of pharma giants may be just the ticket.
Pfizer’s Chief Scientific Officer, Morris Birnbaum, illuminates how the two companies’ therapies will work in tandem by explicating the development of NASH. “First you get fat in the liver,” he says. “And then for reasons which nobody understands, the fat provokes an inflammatory response…and then lastly, you get scarring and fibrosis.” Pfizer’s product will fight the earliest event: the accumulation of fat in the liver. And Novartis’ drug will combat fibrotic scarring and liver inflammation.
Novartis highlights the urgency of pharmaceutical intervention here. “This is an epidemic of 38 million people in the U.S., and to treat all those people who are advanced in their disease requires therapy,” says Eric Hughes, head of the brand’s hepatology development program. “As a physician, I told everyone about exercise, lifestyle changes and diet—and I was lucky if I got 5% that even listened to me.”
Why This Matters
This promising collaboration demonstrates that there remains a readiness and willingness to take on widespread chronic conditions. Nowadays, many drug makers—including Novartis and Pfizer—are devoting more and more resources to rare-disease therapies, which can sometimes earn higher price tags.
