Roche Makes Major MASH Move With $3.5B 89bio Buy

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The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.

Roche is snapping up California biotech 89bio in an acquisition deal that could be worth $3.5 billion, giving the pharma a promising late-stage asset for metabolic dysfunction-associated steatohepatitis.

Under the terms of Thursday’s agreement, Roche will buy all of 89bio’s outstanding shares for $14.50 a pop, a total equity value of $2.4 billion, representing a 52% premium to the biotech’s volume-weighted average trading price over the last 60 days. The Swiss pharma has also given 89bio’s shareholders a contingent value right of $6 per share, which could bump the overall equity value up to around $3.5 billion.

The companies expect to close the deal in the fourth quarter of this year, pending customary conditions.

The centerpiece of the acquisition is 89bio’s FGF21 analog pegozafermin, which is currently in late-stage development for metabolic dysfunction-associated steatohepatitis (MASH). FGF21 is a liver hormone that helps regulate metabolism, and investigational therapies that use this pathway have shown promising potential in reducing fibrosis.

In the Phase IIb ENLIVEN study, data from which were released in March 2023, 27% of patients treated with 44-mg pegozafermin twice a week saw at least a one-stage improvement in fibrosis without worsening of MASH, versus 7% in placebo counterparts. Similarly, 26% of pegozafermin-treated patients achieved resolution of MASH without worsening of fibrosis, as compared with 2% in the placebo group.

89bio in March 2024 kicked off the Phase III ENLIGHTEN-Fibrosis study of pegozafermin, with an eye toward accelerated approval for patients with non-cirrhotic MASH. Pegozafermin ranks among BioSpace’s seven most promising late-stage MASH candidates with the potential to change the market.

The contingent payments under Thursday’s acquisition agreement will depend on certain pegozafermin milestones, such as the drug making its first commercial sale before March 31, 2030 and hitting specific sales targets by certain deadlines. “There can be no assurance that payments will be made” under the contingent value right offer, as per the news release.

With 89bio under its wing, Roche hopes to compete in the red hot MASH space. Currently, the indication is dominated by Madrigal Pharmaceuticals’ THR-beta agonist Rezdiffra, approved in March 2024, and Novo Nordisk’s blockbuster GLP-1 drug Wegovy, which received regulatory clearance for MASH last month.

Roche’s 89bio deal also continues what has been an active buying spree for Big Pharma in recent months. Last week, Novartis put forward $1.4 billion to acquire New York’s Tourmaline Bio and its pipeline of cardiovascular therapies. Meanwhile, AbbVie last month paid $1.2 billion to buy Gilgamesh Pharmaceuticals’ lead psychedelic candidate for depression.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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