Novo Nordisk has agreed to buy Akero Therapeutics and its drug candidate for metabolic dysfunction-associated steatohepatitis (MASH) for $4.7 billion upfront, shortly after claiming FDA approval to add MASH to the label of its GLP-1 agonist semaglutide.
The Danish pharma group is paying $54 per share in cash for Akero, with another $6 per share – around $500 million – payable to shareholders in the US biotech if its MASH therapy efruxifermin is approved for marketing in the US.
In a statement, Novo Nordisk said FGF21 analogue efruxifermin has “first- and best-in-class” potential and complements its focus on developing therapies for people living with diabetes, obesity, and associated illnesses.
MASH is a form of non-alcoholic fatty liver disease (NAFLD), linked to being overweight and having diabetes, that affects millions of people worldwide.
In August, Novo Nordisk’s Wegovy formulation of semaglutide became only the second drug to be approved for MASH after Madrigal Pharma’s THR β-selective agonist Rezdiffra (resmetirom), which is showing strong early growth, with sales of $350 million in the first six months of this year.
Efruxifermin is the only drug treatment to show significant fibrosis regression in a phase 2 trial involving MASH patients who have compensated cirrhosis (F4), according to Novo Nordisk, and is in a trio of phase 3 studies in pre-cirrhotic (F2-F3) MASH and F4 patients.
Novo Nordisk was previously developing an FGF21 analogue called zalfermin as a MASH treatment, but discontinued the programme after concluding that it did not show significant differentiation from semaglutide in efficacy.
The Akero agreement represents the first major acquisition for the Danish group under new chief executive Mike Doustdar, who was brought in earlier this year to turn the business around in the face of growing competition for its diabetes and obesity products.
“MASH destroys lives silently, and efruxifermin has the potential to change that by reversing liver damage,” said Doustdar. “If approved, we believe it could become a cornerstone therapy, alone or together with Wegovy […] to tackle one of the fastest-growing metabolic diseases of our time.”
He alluded to data from the phase 2 HARMONY (F2-F3) and SYMMETRY (F4) trials, which demonstrated 49% and 29% reduction in fibrosis without worsening of MASH, respectively, compared to falls of 19% and 11% in the two studies’ placebo groups.
If all goes to plan, the merger deal is expected to close around the end of the year, said Novo Nordisk.
This is the second major acquisition in the MASH category in the space of a few weeks, coming after Roche agreed to buy 89bio and its late-stage FGF21 analogue candidate pegozafermin for $2.4 billion upfront and a potential total value of $3.5 billion.
GSK also has a stake in the FGF21 analogue category with efimosfermin, which is being prepared for a phase 3 programme.
