Merck leads the new cholesterol-lowering push

Promising data on Merck & Co’s oral PCSK9 inhibitor MK-0616 – plus impressive late-stage results with its pulmonary arterial hypertension project sotatercept – added nearly $11bn to the group’s market cap yesterday. And a look at the PCSK9 pipeline shows Merck is well ahead of its oral rivals. Indeed, one of these recently dropped out, with Novo Nordisk quietly discontinuing NN6435 in the third quarter of last year following phase 2 data. At the time of publication, a spokesperson had not responded to questions about the reasons behind this decision. If eventually approved, Merck’s MK-0616 could take market share from currently approved monthly injectable PCSK9 inhibitors from Amgen and Sanofi/Regeneron, as well as Novartis’s twice-yearly therapy Leqvio. But others are going even longer acting, with a couple of gene editing contenders in early-stage development. Since the last time Evaluate Vantage carried out this analysis, however, one of these has also fallen by the wayside: Precision Biosciences said in January that it was ceasing development of PBGENE-PCSK9. A previous update noted that the group’s partner Iecure, which had been responsible for a phase 1 study, had not completed IND-enabling activities; the deal was signed in September 2021.