Milvexian

Novartis is expanding its prospects in cardiometabolic disease by striking a deal to acquire Anthos Therapeutics, a company in pivotal testing with a blood clot-preventing drug that could offer advantages over anticoagulants currently sold by some of its big pharmaceutical peers. According to deal terms announced Tuesday, Novartis is paying $925 million up front for Anthos. Achieving milestones could bring the payout to as much as $3.1 billion. The deal, which still needs regulatory approvals, is expected to close in the first half of this year. The acquisition represents a homecoming for Anthos’s main asset, abelacimab, a drug that originated in Novartis’s labs. Anthos launched in 2019 with $250 million from Blackstone Life Sciences and a license for global rights to the Novartis drug, known then as MAA868. At the time of the deal, this drug was in mid-stage clinical development. Novartis retained a minority stake in Cambridge, Massachusetts-based Anthos. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech Abelacimab is a monoclonal antibody designed to bind to a clotting protein called Factor XI. Doing so is intended to block activation of this protein that plays a key role in blood coagulation. Drugs are already available to reduce the risk of stroke and blood clots. Xarelto, from Bayer and Johnson & Johnson, and Eliquis, marketed by Bristol Myers Squibb and Pfizer, are blockbuster sellers. But both blood-thinning medicines also come with bleeding risks. Anthos already has clinical trial results topping Xarelto. A Phase 2 test of abelacimab was stopped early in 2023 due to “overwhelming reduction in bleeding.” Detailed trial results published last month in the New England Journal of Medicine show a 62% reduction in major bleeding or clinically relevant non-major bleeding and a 67% reduction in major bleeding compared to treatment with Xarelto. Anthos also reported its drug achieved an 89% reduction in gastrointestinal bleeding. Abelacimab, which is administered intravenously at first and then by monthly subcutaneous injection thereafter, is currently in Phase 3 testing in patients with atrial fibrillation who have a high risk for stroke or systemic embolism. Two additional Phase 3 studies are underway testing the drug as a way to prevent the recurrence of blood clots in patients with cancer. Anthos expects these studies will post data in the second half of 2026. “Abelacimab has the potential to be an important treatment option for the millions of patients globally with atrial fibrillation at high risk of stroke, and we could not have more conviction in the potential of this asset,” Anthos CEO Bill Meury said in a prepared statement. “With its deep roots in the cardiovascular space, Novartis is especially well positioned to advance abelacimab’s clinical development and bring this innovative product to healthcare providers and patients.” presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical Cardiometabolic disease is one of four therapeutic areas that Novartis has identified as core to its strategy. The others are immunology, neuroscience, and oncology. The Anthos acquisition is timely for Novartis. The Swiss pharma giant’s cardiometabolic product lineup is currently anchored by Entresto, a heart failure drug that accounted for $7.8 billion in worldwide sales in 2024, a 30% increase compared to the prior year. But Entresto faces pricing challenges. Patents protecting the product expire in 2025 and 2026. Entresto was also selected as one of the first 10 drugs subject to price negotiation by the Centers for Medicare and Medicaid Services. The negotiated price will take effect in 2026. There have been other efforts to beat Xarelto and Eliquis. In 2023, Bayer stopped a Phase 3 test of asundexian in atrial fibrillation after the study’s data monitoring committee concluded the Factor XIa-blocking oral small molecule was unlikely to be more effective than Eliquis. Meanwhile, Bristol Myers Squibb’s oral Factor XIa inhibitor milvexian is currently in Phase 3 testing in acute coronary syndrome, atrial fibrillation, and secondary stroke prevention. Image: Magicmine, Getty Images

iStock, TBE Novartis is paying $925 million upfront to acquire Anthos Therapeutics, whose launch the pharma backed in February 2019. Novartis wants its late-stage anticoagulant antibody abelacimab back, and on Tuesday, the pharma put up to $3.1 billion on the line to acquire its current owner, the privately-held Boston-based biotech Anthos Therapeutics. Abelacimab is a fully human monoclonal antibody that binds to Factor XI, a central clotting protein—and a well-known target for anticoagulants. In February 2019, Novartis joined hands with the investment firm Blackstone Life Sciences to launch Anthos. At the time, the pharma offloaded abelacimab to the start-up which, along with $250 million in starting capital from Blackstone, was supposed to take the antibody through clinical studies. Now, Novartis is paying $925 million upfront for Anthos and abelacimab, which chief medical officer Shreeram Aradhye on Tuesday called a “potential first-in-class treatment.” Abelacimab, according to Aradhye, could be a “safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis.” Novartis is also pledging up to $2.15 billion in certain regulatory and sales milestones. The acquisition is expected to close in the first half of 2025, pending antitrust and regulatory clearance, as well as other customary conditions. Last month, Anthos published data from the landmark Phase IIb AZALEA-TIMI 71 study in the New England Journal of Medicine , demonstrating that 150-mg abelacimab given monthly achieved a 99% median inhibition of Factor XI, an effect it was able to sustain for more than two years. Patients on abelacimab saw a 62% drop in major or clinically relevant non-major bleeding, as compared with patients on Johnson & Johnson’s Xarelto. The treatment difference was statistically significant, with a p-value less than 0.001. In September 2023, Anthos stopped AZALEA-TIMI 71 ahead of schedule due to the “ overwhelming ” efficacy of abelacimab. According to Novartis’ news release on Tuesday, abelacimab is currently being studied in three Phase III studies, one in atrial fibrillation and two in cancer-associated thrombosis. With the Anthos acquisition, Novartis seeks to succeed where fellow Big Pharma Bayer failed. In November 2023, the company terminated the Phase III OCEANIC-AF study of its Factor XIa blocker asundexian after an independent data monitoring board found that the candidate had “inferior efficacy” to Pfizer’s Eliquis. J&J and BMS also suffered a Factor XIa setback in August 2022 when their candidate milvexian failed to demonstrate a dose response in patients with acute ischemic strokes or transient ischemic attacks. Tuesday’s buyout also continues biopharma’s big-ticket dealmaking streak. Last week, for instance, venture capital firm Bain Capital announced the $3.3 billion acquisition of Japan’s Mistubishi Tanabe. Last month, GSK snapped up IDRx for at least $1 billion and J&J bought Intra-Cellular for $14.6 billion. Another possible acquisition on the horizon is Merck KGaA’s potential deal with SpringWorks, though the companies are still currently in “ advanced discussions ,” with no certainty that they will reach an agreement.