Novo Nordisk can attain MASH sufferers with the current FDA choice increasing approval of its GLP-1 drug Wegovy to the therapy of moderate-to-advanced circumstances of the fatty liver illness. Now it’s acquiring Akero Therapeutics in a multi-billion-dollar deal that brings a late-stage drug candidate with the potential to assist sufferers in probably the most extreme stage of MASH.
Based on deal phrases introduced Thursday, Novo Nordisk pays $54 in money for every Akero share, valuing the biotech at $4.7 billion. A contingent worth proper within the deal makes the Danish pharmaceutical large liable for paying an extra $6 in money per share upon FDA approval of Akero’s drug, efruxifermin, for the therapy of compensated cirrhosis as a result of MASH. Attaining that purpose would add one other $500 million to the payout.
Talking throughout a Thursday convention name, Novo Nordisk CEO Mike Doustdar famous that the Akero deal is the biggest R&D acquisition within the historical past of the corporate. It’s additionally the primary one since he took over as chief govt in August. Doustdar stated a part of his job is making certain Novo Nordisk maintains a management place in diabetes, weight problems, and their associated comorbidities.
“We will solely try this by elevating the innovation bar to carry revolutionary medicines to the market, and thus, impression hundreds of thousands of sufferers worldwide,” he stated. “In the present day’s acquisition additional strengthens the chance to take action.”
MASH, brief for metabolic dysfunction-associated steatohepatitis, develops as fats builds up within the liver, resulting in irritation and the formation of scar tissue. The extent of this liver scarring, referred to as fibrosis, is measured in keeping with a scale starting from F0, representing no fibrosis, to F4, which is cirrhosis. Based on the FDA, about 14.9 million Individuals have MASH. Globally, Novo Nordisk estimates the illness impacts greater than 250 million individuals.
Akero’s efruxifermin is a protein engineered to be a long-acting analog of fibroblast progress issue 21 (FGF21), a liver-secreted hormone that regulates power expenditure and metabolization of fats. The half-life of native FGF21 is lower than two hours. South San Francisco-based Akero engineered efruxifermin with a half-life lasting days, enabling once-weekly dosing of the injectable drug. Earlier this yr, Akero reported Part 2 outcomes exhibiting therapy with efruxifermin over 96 weeks achieved a statistically significant reversal of cirrhosis with no worsening of MASH. To this point, efruxifermin is the one drug to indicate this stage of impact in sufferers with F4 fibrosis.
Novo Nordisk’s weight problems drug Wegovy, which works by activating the GLP-1 receptor, added MASH to its label in August. That FDA choice solely covers MASH sufferers with F2 and F3 fibrosis. The corporate says there’s nonetheless an unmet medical want. Along with the untreated inhabitants of F4 sufferers, a few of these with moderate-to-severe illness could not reply to a GLP-1 drug, the corporate stated in an investor presentation.
MASH was as soon as a graveyard for drug analysis, however that’s modified in recent times. In 2024, Madrigal Pharmaceuticals landed the first approval in MASH for Rezdiffra, an oral small molecule designed to activate THR-beta, a receptor that mediates metabolic exercise within the liver. Rezdiffera’s accelerated approval covers the therapy of moderate-to-advanced MASH.
The Akero acquisition settlement comes three weeks after Roche announced a deal to buy 89bio and its late-stage MASH drug for $2.4 billion. Like Akero’s drug, 89bio’s pegozafermin is a protein engineered to imitate FGF21. Made with know-how giving the drug an extended half-life, the every-two-weeks injection would provides a sufferers a dosing benefit in comparison with weekly injections of Akero’s drug. Two Part 3 assessments of the 89bio drug are ongoing. In the meantime, GSK has mid-stage drug candidate efimosfermin, which it acquired earlier this year in a $1.2 billion deal with Boston Pharmaceuticals. This FGF21 analog’s longer half-life is meant to help once-monthly dosing.
In a observe despatched to traders, Leerink Companions analyst Thomas Smith identified the Akero deal marks the third MASH-related acquisition this yr — all for FGF21-targeted belongings. These transactions reinforce Leerink’s view that this drug class is among the most compelling for addressing fibrosis in MASH. Smith added that the Akero acquisition comes two months after Novo discontinued its inner FGF21 program as a result of a failed Part 2 examine, underscoring that not all FGF21 analogs are equal. Whereas Leerink expects the deal will shut, Smith stated there could also be some Federal Commerce Fee scrutiny given the pipeline overlap of the businesses. There might also be political scrutiny.
Of the three FGF21 MASH drug acquisitions this yr, the Akero deal is the most important. Martin Holst Lange, govt vp, R&D, and chief scientific officer, stated the premium Novo Nordisk is paying is justified. Simply as Novo Nordisk sees variations throughout the GLP-1 house, it sees variations in FGF21 medicine, he stated. Efruxifermin was not solely totally different from Novo’s internally developed FGF21 drug candidate, it has proven superior efficacy and doubtlessly higher security and tolerability in contrast different FGF21 medicine up to now.
“So we consider that with this acquisition we not solely have wholesome potential to be finest at school, but in addition, and that is clearly a timing perspective, first at school as a result of it’s a extra progressed program,” Lange stated.
Three Part 3 research are underway for efruxifermin with a complete enrollment of roughly 3,500 individuals. The primary readout, from a real-world examine, is predicted as early as subsequent yr with the opposite research yielding information in years to come back. Within the meantime, Lange stated the corporate plans to discover potential combos of efruxifermin with its GLP-1 drug portfolio. The corporate can even examine functions of the Akero drug in different indications.
The $54 per share value Novo is paying for Akero is only a 16% premium to the inventory’s Wednesday closing value, nevertheless it’s a 42% premium to Akero’s closing value on Might 19 earlier than hypothesis emerged about an acquisition. The phrases of the contingent worth proper require efruxifermin to safe FDA approval by June 30, 2031.
The acquisition has been accredited by Akero’s board of administrators however nonetheless wants shareholder and regulatory approvals. The businesses anticipate to finish the transaction by the top of this yr.
Picture: Liselotte Sabroe/Scanpix Denmark/AFP, through Getty Photos
