Rock metabolic drug strategy extends to the puree of a liver disease with an acquisition of $ 2.4 billion

There are two drugs approved by the FDA for metabolic disorder known as Mash. Roche pays $ 2.4 billion to acquire 89bio and its puree medication at a late stage, giving the Swiss pharmaceutical giant the possibility of bringing a third medication and a different action mechanism to this prevalent liver disease.

Depending on the transaction conditions announced Thursday, Roche will pay $ 14.50 for all 89bio stocks in circulation, which represents a bonus of almost 80% of the action price on Wednesday. This price varies from 89bio to 2.4 billion dollars, but the shareholders of the company have the possibility of receiving more if its medication crosses certain milestones.

The main asset of 89bio based in San Francisco is Pegozafermin, an experimental treatment of steatohepatitis associated with metabolic dysfunction, or puree. In this chronic metabolic disorder, the accumulation of fat in the liver leads to inflammation and liver scars called fibrosis. The disease has four stages; The most serious is stage 4 or F4, which is the cirrhosis of the liver. The FDA estimated that 14.9 million Americans have a puree, which, in serious cases, can force the patient to receive organ transplantation.

Pegozafermin is an engineering protein designed to represent FGF21, a metabolic hormone secreted by the liver which regulates energy expenditure and the metabolization of fat. The long half-life of this medication allows the injection dosage every two weeks. A phase 3 study evaluating the effect of the drug on fibrosis F2 or F3 should have preliminary data in the first half of 2027. Another phase 3 test evaluating the Pegozafermin effect on liver cirrhosis consists in registering patients with Mash F4; The data is expected in the first half of 2028.

Oncology is the best therapeutic zone in rock by income, but the Swiss pharmaceutical giant turned to the realization in order to diversify. Last year, Roche paid $ 2.3 billion to buy Carmot Therapeutics and its obesity and diabetes of candidates targeting the GLP-1 and GIP receivers. Earlier this year, Roche paid Zealand Pharma $ 1.65 billion in advance to start a partnership on this drug targeting the amylin of biotechnology for obesity. In the announcement of the acquisition of 89bio, the CEO of Roche Group, Thomas Schinecker, said that the agreement reinforced the portfolio of the pharmaceutical giant in cardiovascular, renal and metabolic diseases. He added that the 89bio medication could be combined with existing Roche assets – a point that the company made when Carmot and Zélandais transactions were announced.

“We are strongly encouraged by the potential of Pegozafermin to become an option of transforming treatment in puree, one of the most common comorbidities of obesity, and to meet the various needs of patients associated with this complex disease,” said Schinecker. “With its combined anti-fibrotic and anti-inflammatory mechanism, Pegozafermin could potentially offer effectiveness in the best disease to all moderate to severe puree patients.”

The drug closest to the Pegozafermin is the Akero Therapeutics’ efruxifermin, which is also a protein designed to be a analog for the FGF21. This medication injected once a week is currently being evaluated in three phases 3. GSK obtained a drug candidate Mash FGF21 in May, paying $ 1.2 billion to efimosfermin Alfa, an RNA medication interfering at Boston Pharmaceuticals. This medication ready for phase 3 could offer less frequent dosage as an injection formerly months.

The first puree medication was Madrigal Pharmaceutical’s Rezdiffra, a small molecule designed to activate the THR-Beta, a receiver that intervenes in metabolic activity in the liver. Last year, the accelerated approval of the FDA of this pill once a day covers the treatment of patients with moderate advanced disease, which is consistent with F2 or F3 fibrosis. Last month, the NOVO-1 Nordisk Wegovy GLP-1 obesity medication widened its label to include moderate to advance mash. Novo developed an FGF21 analog for fatty liver disease, but recently interrupted this program.

Leerink Partners analyst Thomas Smith told investors that the company considers that the puree market will be made up of my many drugs covering several therapeutic classes. The 89bio acquisition provides additional validation for the FGF21 class, which, according to Leerink, has the most convincing action mechanism for puree processing based on high phase 2B data in patients with Mash with advanced fibrosis and F4 compensated cirrhosis.

Leerink projects $ 4.7 billion in advanced world revenue for the drug 89bio by 2035, including 2.6 billion dollars in advanced fibrotics and $ 1.6 billion in cirrhotic puree. These projections are increasing well for the prospects for additional payments to the shareholders of 89bio. The acquisition contract includes a non -traditional conditional value right which will pay up to $ 6 per cash share if the 89bio medication reaches milestones, which has potentially carried the value of the agreement up to $ 3.5 billion. The first milestone, paying $ 2 per share, is shifted by the first commercial sale of Pegozafermin in CIRRHOTIC patients in F4 puree. This step should be taken by the end of the first quarter of 2030. An additional number of $ 1.50 per share could be paid if the drug 89BIO reaches the annual global sales of at least $ 3 billion in a calendar year by the end of 2033. reach 4 billion dollars in net sales by the end of 2035 would trigger the final payment of $ 2.50 by action.

The acquisition of 89bio de Roche should end in the fourth quarter of this year. 89BIO authorized Pegozafermin from Teva Pharmaceutical Industries in 2018 for $ 6 million in advance with an additional $ 67.5 million linked to the realization of milestones, according to regulatory biotechnology deposits. Teva is eligible for receiving sales fees if the drug reaches the market.

Photo: Giuseppe Aresu / Bloomberg, via Getty Images