Gilead tosses $100M milestone chip in its fast-growing gamble on new NASH drugs

Almost two years to the day since Gilead $GILD struck a deal worth up to $470 million for Phenex’s FXR agonist program for NASH, the big biotech has followed up with a $100 million milestone payment. Phenex execs say that Gilead has selected GS-9674 to test in NASH, primary biliary cholangitis (PBC) and primary sclerosing cholangitis.

The drug is now in Phase II in all three indications.

Gilead has been investing heavily in an expanding NASH pipeline. Last November it added a $200 million milestone — on top of a $400 million upfront — to Nimbus for an ACC inhibitor now known as GS-0976.

“This milestone payment is in addition to a further undisclosed milestone from the same program earlier this year for GS-9674 entering Phase I studies,” said Phenex CFO Thomas Hoffmann. And the plan is to plow that money back into their pipeline, aiming to go all the way next time on their own.

Says Hoffman: “It allows us to build up a drug discovery platform in liver and gastrointestinal diseases as well as in oncology where we can afford to evaluate radical novel innovative and promising approaches.”

“Our next big goal is to take a drug all the way from research to approval and marketing,” said CEO Claus Kremoser. The biotech is based in Ludwigshafen, Germany.

Gilead faces an array of rivals exploring new drugs for NASH and fatty liver disease. And they’re also betting big. Last fall Allergan $AGN handed Tobira investors a whopping 6X cash premium for the NASH-focused company in a deal that could be worth up to $1.7 billion. And just today J&J revealed that it picked up an option to buy Bird Rock Bio and its NASH drug.

Gilead faces big challenges on the R&D front. It’s been confronted with a string of serious setbacks on its most advanced therapies as its hep C franchise fades and drug prices fall.

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