Pacibekitug

To bring pacibekitug into its pipeline, Novartis is paying $48 per share of New York-based Tourmaline Bio.\n Novartis is paying $1.4 billion to get its hands on Tourmaline Bio and its former Pfizer cardiovascular drug that impressed in a phase 2 study earlier this year.At the center of the deal is pacibekitug, an antibody targeting interleukin-6, which hit the primary endpoint of a phase 2 study in May by sharply reducing levels of C-reactive protein (CRP), a biomarker for cardiovascular disease risk, in patients with chronic kidney disease.Tourmaline had pitched that study as the launch pad for developing pacibekitug as a treatment for atherosclerotic cardiovascular disease (ASCVD) along with other cardiovascular diseases. Interleukin-6 is a proinflammatory cytokine, and inflammation is known to be a driver of atherosclerosis. The liver produces CRP in response to inflammation, and patients with atherosclerosis typically have higher levels of the protein in their blood.“With no widely adopted anti-inflammatory therapies currently available for cardiovascular risk reduction, pacibekitug represents a potential breakthrough in addressing residual inflammatory risk in ASCVD with a differentiated mechanism of action targeting IL-6,” Novartis Chief Medical Officer Shreeram Aradhye, M.D., said in this morning’s release.“Inflammation is a major driver of cardiovascular disease, and the team at Tourmaline has made significant progress with this asset,” Aradhye added. “We are excited to bring pacibekitug into the Novartis portfolio and collaborate with the Tourmaline team to advance its development as we diversify our efforts in cardiovascular care.”To bring pacibekitug into its pipeline, Novartis is paying $48 per share of the New York-based biotech—equivalent to $1.4 billion—which marks a significant increase on the $30.18 price that Tourmaline’s shares closed at on Monday and is well above the $20 at which the company’s stock entered the year.The Tranquility phase 2 trial, which boosted Tourmaline’s fortunes, enrolled 143 patients with elevated levels of CRP and chronic kidney disease, who are at high risk of ASCVD.Individuals who received 50 mg of pacibekitug saw an average reduction in CRP levels at Day 90 of 86%, while a 25-mg group saw 75%, and the 15-mg group dropped 85%, compared to a 15% reduction in the placebo cohort. At the time, the biotech described the drop in CRP levels as “rapid, deep and durable,” while pointing out that the study marked the first time that an IL-6 inhibitor had been tested in a clinical trial with quarterly dosing.Pacibekitug originated at Pfizer, with Tourmaline licensing the asset in 2022. In addition to the cardio indications, the biotech has been testing the antibody in a phase 2 trial in the autoimmune disorder thyroid eye disease, while Pfizer had previously studied pacibekitug in Crohn\'s disease, lupus and rheumatoid arthritis. “Our mission at Tourmaline has been to establish new standards of care in areas of high unmet medical need, and today’s transaction announcement both underscores our commitment to that focus and also delivers compelling shareholder value,” Tourmaline CEO Sandeep Kulkarni, M.D., said in the Sept. 9 release.“Novartis shares our conviction in the critical, but largely unaddressed, role of inflammation in driving cardiovascular diseases and will be an ideal partner to accelerate the development of pacibekitug,” Kulkarni added.Tourmaline got a boost for advancing its sole asset in 2023 through a reverse merger with Talaris Therapeutics, which put Tourmaline on the Nasdaq with a $75 million private placement.For Novartis, the acquisition of Tourmaline follows a summer in which the Swiss pharma padded out its cardiovascular pipeline via a multifaceted collaboration with Chinese siRNa biotech Argo Biopharmaceutical and a four-year pact with ProFound Therapeutics.Novartis’ cardiovascular offering already includes the bad-cholesterol–lowering med Leqvio alongside the heart failure medication Entresto. The pharma’s late-stage pipeline features pelacarsen, an antisense med aimed at preventing cardiovascular events in patients with elevated levels of lipoprotein(a).

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.