Ziltivekimab

Novartis said Tuesday that it would buy Tourmaline Bio for $1.4 billion in a bid to revitalize its cardiovascular offering. The Swiss pharma said it would pay $48 per share in cash for Tourmaline, a premium of nearly 60% to the biotech’s closing price on Monday. Tourmaline’s main asset, an anti-IL-6 antibody called pacibekitug, generated promising mid-stage data in atherosclerotic cardiovascular disease in May. And Novartis is looking to revitalize its heart disease drug pipeline, considering the patent for its heart failure blockbuster Entresto is set to expire soon. Entresto is Novartis’ bestselling drug, making over $4 billion last year. In Tourmaline’s trial, called TRANQUILITY, pacibekitug sharply cut levels of an inflammation marker called high-sensitivity C-reactive protein (hs-CRP) in patients with chronic kidney disease. Both the disease and the biomarker are risk factors for atherosclerosis, a condition in which plaque builds up in the arteries, raising the risk of events like heart attacks and strokes. A further cut from the study, presented at the annual meeting of the European Society of Cardiology last month, showed that the reductions in hs-CRP were consistent across subgroups, and the drug also cut levels of other disease biomarkers, including lipoprotein(a), fibrinogen and serum amyloid A. Analysts from Leerink wrote in a Sept. 2 note that the TRANQUILITY results “showcase pacibekitug’s competitive balance of efficacy and safety,” adding that the drug’s less frequent subcutaneous dosing could be a differentiator versus other drugs. Tourmaline’s antibody may be dosed quarterly, whereas competing IL-6 products like CSL Behring’s Phase 3-stage clazakizumab and Novo Nordisk’s ziltivekimab are given monthly. Ziltivekimab is in a late-stage trial called ZEUS in patients with cardiovascular disease, chronic kidney disease and inflammation, which is due to yield data next year. Success on a surrogate biomarker endpoint is a start, but pacibekitug will have to prove itself in a larger Phase 3 investigation to see if it really does reduce the risk of heart events. Tourmaline was known to be planning a cardiovascular outcomes trial of the drug in ASCVD. Pacibekitug is designed to reduce systemic inflammation by blocking IL-6. Novartis said that inflammation is a major driver of cardiovascular disease. The antibody, which came from Pfizer, is also being tested in thyroid eye disease , with a Phase 2 trial set to report in 2026. And Tourmaline was also planning to start a proof-of-concept study in a second vascular indication called abdominal aortic aneurysm this year. Novartis will buy Tourmaline through an indirect wholly-owned subsidiary called Torino Merger Sub. After the tender offer is completed, Novartis intends to merge the acquiring subsidiary with Tourmaline, resulting in the latter becoming a Novartis subsidiary.