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Roche strengthens its pipeline by acquiring 89bio and its promising MASH treatment, Pegozafermin, enhancing options for metabolic disease therapies.
Pegozafermin is a FGF21 analog currently in late-stage development for MASH in moderate and severe fibrotic patients.
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Roche announced it has entered into a definitive merger agreement to acquire 89bio, along with its FGF21 analog Pegozafermin, which is currently in late-stage development for Metabolic Dysfunction-Associated Steatohepatitis (MASH).
“This acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing program in our pipeline,” said Thomas Schinecker, Roche Group CEO. “We are highly encouraged by Pegozafermin’s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease. With its combined anti-fibrotic and anti-inflammatory mechanism, Pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients.”1
Roche’s acquisition of 89bio reflects the company’s dedication in advancing therapy treatment options for cardiovascular, renal, and metabolic disease indications, including a focus on patients diagnosed with obesity and other health challenges such as MASH. The acquisition additionally allows Roche to develop and expand its pipeline to target various causes of metabolic disease. Aside from just expanding its pipeline, Roche will also expand its workforce, as 89bio employees are expected to join the Roche Group under Roche’s pharmaceuticals division.
According to the terms of the agreement, Roche will provide its tender offer to acquire all outstanding shares of 89bio at a price of $14.50-per-share in cash. Roche will also provide a non-tradable CVR, allowing Roche to receive select milestone payments upwards of $6-per-share through a second-step merger.1 The non-tradable CVR’swill entitle holders to receive $2-per-share following Pegozafermoin’s first commercial sale, $1.50-per-share if Pegozafermoin reaches annual global net sales of$3 billion in any year, and $2.50-per-share if Pegozafermoin reaches $4 billion in annual global net sales in any year. If all CVR conditions are met it will represent upwards of $1 billion in additional cash consideration for 89bio.
The transaction is anticipated to close in the fourth quarter later this year, and is subject to standard closing conditions, which includes a tender of outstanding shares of 89bio’s common stock, along with the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.1
Pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) designed to address critical unmet needs in MASH.1 With its anti-fibrotic and anti-inflammatory mechanism of action, along with its favorable safety profile, Pegozafermin is positioned to potentially deliver best-in-disease efficacy for patients suffering from moderate to severe liver fibrosis and cirrhotic MASH.1 Pegozafermin also employs a unique mechanism of action holding the potential to improve efficacy and tolerability, along with unlocking opportunities for future combination development with incretins.
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