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Novartis joins Allergan in pushing NASH combo into late stage

April 18, 2017

Looking to leapfrog some intense competition to field new drugs for NASH and fatty liver disease, pharma giant Novartis has struck a deal to partner with Allergan on a new combo approach that will start out in a Phase IIb trial.

Novartis is combining an FXR agonist with Allergan’s cenicriviroc — CVC — for the treatment of non-alcoholic steatohepatitis. And they’re keeping the numbers side of the arrangement under wraps.

Novartis believes that Allergan’s CVC — which tackles CCR2 and CCR5, a pair of inflammatory chemokine receptors — is the kind of drug that will figure prominently in new cocktails for NASH, a major market opportunity that has attracted a lineup of rivals like Gilead, Intercept and Shire.

The deal with Novartis marks a quick validation of Allergan CEO Brent Saunders’ decision to pay a huge premium to bag Tobira last fall in a deal worth up to $1.7 billion — including a cash upfront worth 6 times the biotech’s final share price. Tobira’s stock had been battered by the drug’s failure in a Phase IIb trial for NASH last summer, but investigators gathered positive data for a key secondary endpoint that was moved up to the primary for a prospective Phase III trial.

Allergan has been building a portfolio of new drugs for NASH, adding preclinical FXR agonists in a deal to acquire Akarna on the same day it bagged Tobira. Novartis’ FXR agonist is in a Phase II study, though, moving the combo into a much more advanced position.

Novartis, meanwhile, has also set its sights on becoming a late-stage player in the field. The pharma giant struck a deal to collaborate with Conatus on its oral pan-caspase inhibitor emricasan for NASH last December.

NASH and liver fibrosis have become a major target as its prevalence spreads rapidly in the US and the world.

Novartis likes to work quietly ahead of Phase III but carry a big checkbook for any experimental products it may need along the way. In this case, the Big Pharma operation is going after a megamarket some excited analysts have pegged at a potential $35 billion. To get there, though, developers will need to find easier ways to diagnose the disease to identify patients, many of whom do not necessarily face an immediate health threat.
“Our clinical collaboration with Allergan expands our development programs for NASH, bringing together science and expertise to investigate a potential new combination therapy in an effort to make a positive change for people living with this condition,” said Vas Narasimhan, Novartis’ CMO and head of drug development.  “We believe that collaboration is key to developing the best possible treatments that are urgently needed for NASH patients.”

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