The management of cardiovascular disease often involves a range of medications, but surprisingly few focus on reducing inflammation. Novartis is strategically advancing its portfolio with an innovative anti-inflammatory drug candidate, part of its ambitious $1.4 billion acquisition of Tourmaline Bio. This company has developed a promising antibody that is ready for Phase 3 trials, targeting a crucial pathway for various cardiovascular conditions. The acquisition provides Novartis with the chance to catch up with competitors like Novo Nordisk and CSL Behring, who are pursuing similar targets, potentially offering a favorable dosing regimen that could enhance patient compliance.
The agreement, announced on Tuesday, outlines that Novartis will pay $48 in cash for each share of Tourmaline, representing a substantial 57% premium over Tourmaline’s closing stock price from the previous day. Following the announcement, shares of the New York-based biotechnology firm opened at $47.62, indicating strong investor interest in the potential of this acquisition.
Tourmaline’s primary focus is on treating atherosclerotic cardiovascular disease (ASCVD), a condition characterized by the accumulation of plaque within the arterial walls. While various cholesterol-lowering drugs exist to manage ASCVD, many of these treatments, including commonly prescribed statins, require daily administration. In contrast, Tourmaline’s drug, pacibekitug, is a monoclonal antibody designed to inhibit interleukin-6 (IL-6), a protein integral to the inflammatory response. This target has already been validated, as IL-6-blocking antibodies are available for certain inflammatory disorders, though none have yet been approved for cardiovascular applications.
Pacibekitug is designed as a long-acting antibody, optimizing its binding affinity to IL-6 while ensuring a long half-life and minimal risk of provoking an immune response against the treatment. Tourmaline is developing this drug for subcutaneous administration once every three months, a regimen that promises to be less cumbersome for patients, thereby enhancing adherence compared to daily pill regimens.
In the context of ASCVD, Tourmaline intends to leverage the anti-inflammatory properties of pacibekitug to mitigate the risk of serious cardiovascular events, including death, nonfatal myocardial infarction, and stroke. In May, Tourmaline shared preliminary Phase 2 results demonstrating that both quarterly and monthly dosing of the drug resulted in significant reductions in C-reactive protein, a recognized biomarker for inflammation. The safety profile and tolerability of the drug were comparable to that of a placebo, indicating a promising future. Following these findings, Tourmaline announced plans to advance pacibekitug into a Phase 3 trial focused on cardiovascular outcomes for patients suffering from ASCVD, with an additional Phase 2 study planned for abdominal aortic aneurysm.
“Currently, there are no widely accepted anti-inflammatory therapies available for reducing cardiovascular risk. The introduction of pacibekitug could signify a potential breakthrough in addressing the persistent inflammatory risk associated with ASCVD through a unique mechanism of action that specifically targets IL-6,” stated Shreeram Aradhye, president of development and chief medical officer at Novartis, in a prepared statement.
Meanwhile, Novo Nordisk is also working on an IL-6-blocking antibody named ziltivekimab, currently undergoing Phase 3 clinical trials targeting ASCVD, heart failure with preserved ejection fraction, and acute myocardial infarction. CSL Behring is advancing its own candidate, clazakizumab, an IL-6 inhibitor now in late-stage clinical development for patients with end-stage kidney disease associated with diabetes or ASCVD. Both ziltivekimab and clazakizumab require monthly injections, making the less frequent quarterly dosing of pacibekitug a distinct competitive advantage within the IL-6 antibody drug class.
Within its therapeutic focus areas, Novartis has prioritized cardiovascular, renal, and metabolic disorders as one of its four core domains, alongside immunology, neuroscience, and oncology. The company’s leading revenue-generating cardiovascular product is Entresto, a medication used for chronic heart failure and hypertension, which generated over $7.8 billion in sales in 2024. However, the expiration of Entresto’s patents this year and its inclusion in price negotiations by the Centers for Medicare and Medicaid Services have raised concerns about future revenues.
As the revenue from Entresto is expected to decline due to generic competition and ongoing CMS negotiations, Novartis is proactively pursuing acquisitions to bolster its cardiometabolic drug portfolio. Earlier this year, Novartis finalized a $925 million agreement to acquire Anthos Therapeutics and its leading drug, abelacimab, a promising treatment for blood clot prevention initially developed within Novartis. In April, Novartis also agreed to an $800 million deal for Regulus Therapeutics and its Phase 3 program targeting a rare kidney disease. Another significant product for Novartis in the cardiovascular space is Leqvio, an RNA interference-based cholesterol-lowering medication that contributed $754 million in revenue in 2024, marking a remarkable 112% increase from the previous year. Leqvio was approved by the FDA in 2021 after Novartis’s acquisition of The Medicines Company for $9.7 billion in 2019.
Founded in 2021, Tourmaline Bio entered into a licensing agreement with Pfizer the following year to secure global rights to the anti-IL-6 antibody now known as pacibekitug. Pfizer had already progressed the drug to Phase 2 testing prior to the deal. Tourmaline made an initial payment of $5 million in cash to Pfizer, alongside granting the pharmaceutical giant a 15% equity stake in the company, as disclosed in regulatory filings. This agreement positions Pfizer to potentially earn up to $128 million tied to the achievement of various development and regulatory milestones, with additional sales milestone payments of up to $525 million if the antibody reaches the market, plus royalties from product sales.
Tourmaline became publicly traded after a reverse merger in 2023 with Talaris Therapeutics, a cell therapy developer facing challenges. Prior to this merger, Tourmaline had successfully raised $125 million in financing to support its research and development efforts.
Both Novartis and Tourmaline’s boards of directors have approved the acquisition, although it still requires the standard approvals and the tender of the majority of outstanding shares of Tourmaline. The companies anticipate finalizing the deal by the fourth quarter of this year, after which Tourmaline will function as a subsidiary under the Novartis umbrella.
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