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

Anthos Therapeutics’ anticoagulant poses a lower risk of bleeding events than Bayer and J&J’s Xarelto when used to prevent blood clots in atrial fibrillation patients, full results from a mid-stage trial suggest. Anthos is already investigating the drug in Phase 3, but several other companies are also at this stage with similarly-acting drugs — and one of these, Bayer’s asundexian, failed badly. The trial of Anthos’ abelacimab was stopped early for “overwhelming” efficacy in September 2023 . The antibody is designed to bind to factor XI to block its transformation into the activated form, factor XIa. Full data from the open-label Phase 2 trial, which enrolled 1,287 patients with atrial fibrillation and a moderate-to-high risk of stroke, were published in the NEJM on Wednesday. They showed that subcutaneous abelacimab 150 mg once monthly achieved a median 99% inhibition of factor XI at a median follow-up of 21 months. It also demonstrated a statistically significant 62% reduction in bleeds that were designated either major or clinically relevant non-major compared with the oral factor Xa inhibitor Xarelto at 20 mg once daily. This was the study’s primary endpoint. Curiously, however, the lower abelacimab dose of 90 mg appeared more effective than the higher dose, allowing a 69% cut in these kinds of bleeding events versus Xarelto. Anthos’ antibody also permitted a statistically significant 67% reduction in major bleeding alone versus Xarelto. It also cut gastrointestinal bleeding by 89%, though no claims of significance were made here. Anthos is already conducting a Phase 3 trial of abelacimab in high-risk atrial fibrillation patients who have been deemed unsuitable for oral anticoagulation; data could emerge late next year. Anthos’ chief medical officer Dan Bloomfield said in a Wednesday release that factor XI inhibition has “the potential to prevent thrombotic events without affecting normal hemostasis.” This thesis has prompted other players to develop factor XI drugs. Regeneron is pushing two such antibodies into Phase 3 trials after positive mid-stage data in patients who had undergone knee arthroplasty. Bristol Myers Squibb and J&J are conducting three large Phase 3 trials of their oral factor XIa inhibitor milvexian, which yielded mixed Phase 2 data . The trial in atrial fibrillation could generate results in 2027. However, a major Phase 3 study of Bayer’s similar pill in atrial fibrillation was a catastrophe . The trial was stopped early due to asundexian being less effective than the control, Eliquis. Another large-scale Phase 3 trial of the product, in a similar setting, is ongoing. Anthos was launched with $250 million in funding by Blackstone in 2019 .