Roche has dipped its toe in the M&A water with an agreement to buy US biotech 89bio and its late-stage candidate for metabolic dysfunction-associated steatohepatitis (MASH).<\/p>\n
The $14.50-per-share deal equates to a purchase price of $2.4 billion at closing, with Roche dangling another $6 per share in the form of a contingent value right (CVR) that will be payable if 89bio’s lead drug pegozafermin achieves certain unspecified objectives. If that occurs, the value of the deal will swell to $3.5 billion.<\/p>\n
Pegozafermin<\/a> is from a class known as FGF21 analogues, one of a group of drugs in clinical development for MASH with that mechanism of action that also includes Akero’s efruxifermin<\/a> in phase 3 development and GSK’s efimosfermin<\/a>, which is being prepared for phase 3.<\/p>\n Efruxifermin requires dosing once a week by injection, while pegozafermin is being tested in phase 3 with a dose every one or two weeks, depending on the indication, and efimosfermin lends itself to once-monthly dosing.<\/p>\n 89bio’s drug is in two phase 3 trials in MASH \u2013 ENLIGHTEN-Fibrosis in non-cirrhotic (F2-F3) MASH patients and ENLIGHTEN-Cirrhosis trial in compensated cirrhotic (F4) MASH \u2013 as well as a third pivotal study called ENTRUST in severe hypertriglyceridaemia (SHTG).<\/p>\n MASH is a form of non-alcoholic fatty liver disease (NAFLD) that affects millions of people worldwide and has been billed as pharma’s next big growth area, with some analysts predicting a market potentially worth tens of billions of dollars a year.<\/p>\n At the moment, the only two approved therapies for MASH are Madrigal Pharma’s oral THR \u03b2-selective agonist Rezdiffra<\/a> (resmetirom), which was cleared in the US last year and looks to be on a path to blockbuster status with sales of $350 million in the first half of this year, and Novo Nordisk’s blockbuster GLP-1 agonist Wegovy<\/a> (semaglutide).<\/p>\n Roche chief executive Thomas Schinecker said the merger agreement with 89bio \u2013 which would lead to the San Francisco-based biotech becoming a wholly-owned subsidiary of the Swiss group \u2013 will strengthen its pipeline in cardiovascular, renal, and metabolic diseases and “offers opportunities to explore combinations with existing programmes in our pipeline.”<\/p>\n