Anthos Therapeutics is a clinical-stage biopharmaceutical company developing abelacimab, a potential first-in-class monoclonal antibody targeting the FXI inhibition pathwayAbelacimab is currently in Phase 3 development, with the lead indication for prevention of stroke and systemic embolism in patients with atrial fibrillationAcquisition adds a late-stage asset and is aligned with Novartis strategic focus, strength and expertise in the cardiovascular therapeutic areaTransaction expected to close in the first half of 2025, subject to customary closing conditions Basel, February 11, 2025 – Novartis today announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, privately held, clinical-stage biopharmaceutical company with abelacimab, a late-stage medicine in development for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The transaction, which is subject to customary closing conditions, is fully in line with Novartis’ growth strategy and therapeutic area focus, leveraging the company’s strength and expertise in the cardiovascular area. Anthos Therapeutics, launched by Blackstone Life Sciences and Novartis in 2019, has advanced abelacimab through clinical development under a license from Novartis. Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Phase 2 data showed a significant reduction in bleeding events in patients taking abelacimab versus a standard of care direct-oral anticoagulant in patients with atrial fibrillation (AZALEA1,2). Three Phase 3 clinical trials are ongoing for patients at risk of arterial and venous clots, one in patients with atrial fibrillation (LILAC-TIMI 763) and two in cancer associated thrombosis (ASTER4) and (MAGNOLIA5). “We are excited to join forces to advance the development of abelacimab, a potential first-in-class treatment and safer approach for stroke prevention in atrial fibrillation as well as cancer-associated thrombosis,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Welcoming Anthos Therapeutics strengthens our focus in the cardiovascular space and complements our portfolio of life-changing treatments, comprehensive clinical programs, and strategic collaborations that help thousands of patients with heart disease around the world.” In July 2022 abelacimab received a Fast Track Designation from the FDA for the treatment of thrombosis associated with cancer. In September 2022 abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. “Abelacimab is a potential first-in-class medicine, which promises to be an effective and safer approach to preventing thrombosis and stroke than the current standards of care.” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. “We are proud that this medicine originated at Novartis and have been impressed with the Anthos Therapeutics team’s expertise and dedication and with the great progress they have made on the program. Now is the right time to bring abelacimab back into the Novartis CRM pipeline.” Transaction DetailsUnder the terms of the agreement, Novartis will make an upfront payment of USD 925 million upon closing of the transaction, subject to certain customary adjustments, and potential additional payments of up to USD 2.15 billion upon achievement of specified regulatory and sales milestones. The transaction is expected to close in the first half of 2025, subject to satisfaction of customary closing conditions. About AbelacimabAbelacimab is a novel, investigational, highly selective, fully human monoclonal antibody that binds tightly to Factor XI to block its activation and prevent the generation of the activated form (Factor XIa). This mimics natural Factor XI deficiency, which is associated with protection from thromboembolic disease. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for abelacimab, the acquisition of Anthos Therapeutics, Inc., or regarding potential future revenues from abelacimab. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that abelacimab will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that the expected benefits or synergies from this transaction will be achieved in the expected timeframe, or at all, nor can there be any guarantee that abelacimab will be commercially successful in the future. In particular, our expectations regarding abelacimab or the transaction described in this press release could be affected by, among other things, the satisfaction of customary closing conditions including regulatory approvals, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References1. Samer Al Said, et al. Bleeding with the FXI Inhibitor Abelacimab compared with Rivaroxaban in Patients on Antiplatelet therapy: A Prespecified Analysis of the AZALEA-TIMI 71 Trial. Available from: https://timi.org/wp-content/uploads/2024/11/Samer-Al-Said-Bleeding-with-the-FXI-Inhibitor-Abelacimab-compared-with-Rivaroxaban-in-Patients-on-Antiplatelet-therapy-A-Prespecified-Analysis-of-the-AZALEA-TIMI-71-Trial-.pdf. Accessed February 2024. 2. Ruff C, Patel S, et al. Abelacimab versus Rivaroxaban in Patients with Atrial Fibrillation. N Engl J Med. 2025; 392 (4):361-371.doi:10.1056/NEJMoa2406674 3. ClinicalTrials.gov. NCT05712200. Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76) (LILAC-TIMI 76). Available from: https://clinicaltrials.gov/study/NCT05712200?term=NCT05712200&rank=1. Accessed February 2024.4. ClinicalTrials.gov. NCT05171049. A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE. Available from: https://clinicaltrials.gov/study/NCT05171049. Accessed February 2024.5. ClinicalTrials.gov. NCT05171075. A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/ Genitourinary Cancer and Associated VTE (MAGNOLIA). Available from: https://clinicaltrials.gov/study/NCT05171075. Accessed February 2024. # # # Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com
Tag: Anthos Therapeutics
Data Published Today in the New England Journal of Medicine Demonstrates Anthos Therapeutics’ novel Factor XI inhibitor, Abelacimab 150mg, Reduced Major or Clinically Relevant Non-Major Bleeding by 62% Compared to Rivaroxaban (Xarelto) in Patients with Atrial Fibrillation
Secondary endpoints also showed a highly significant 67% reduction in major bleeding and an 89% reduction in gastrointestinal (GI) bleeding The company’s AZALEA-TIMI 71 study is the longest head-to-head study of a Factor XI inhibitor vs. a direct oral anticoagulant (DOAC) CAMBRIDGE, Mass., Jan. 22, 2025 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a transformative, clinical-stage…
Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke
75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P
Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)
CAMBRIDGE, Mass., September 18, 2023 (BUSINESS WIRE)– Anthos Therapeutics, Inc., a clinical stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences, announced today that the AZALEA-TIMI 71 Phase 2 study in 1,287 patients with atrial fibrillation at moderate-to-high risk of stroke, met its primary endpoint. The study has been stopped early […]
Anthos Therapeutics Supported Global Survey of 3000+ Patients Prescribed Anticoagulants Detailing Impact of Patient-Relevant Bleeding (PRB) Presented at ISTH 2023
NEWS PROVIDED BY Anthos Therapeutics → June 26, 2023 07:00 ET Patient-Centric Survey Conducted in Collaboration with StopAfib.org and the National Blood Clot Alliance Findings Suggest “Patient-Relevant Bleeding” More Accurate Than Current Terminology, Capturing Effects on Patient Quality of Life More than Half of Patients Reported Needing to Adjust Their Lifestyles to Reduce the Risk […]
First Patient Enrolled in Phase 3 Trial Evaluating Abelacimab in High-Risk Patients with Atrial Fibrillation Deemed Unsuitable for Current Anticoagulants
FDA Fast-Track designation was granted to investigate abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation LILAC-TIMI 76 trial is the third Phase 3 study with abelacimab initiated by Anthos Therapeutics Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity […]
Anthos Therapeutics Announces that Abelacimab Has Received FDA Fast Track Designation for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation
This is the second Fast Track designation issued by the FDA for abelacimab Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity CAMBRIDGE, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today […]
Four New Sets of Pre-Clinical Data Further Expands the Evidence Supporting Abelacimab
Additional Pharmacodynamic Data on Abelacimab Released at the 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) CAMBRIDGE, Mass., July 13, 2022 /PRNewswire/ — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that four new research updates were presented on abelacimab during the Venous Thromboembolism poster session at […]
Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer
Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a Phase 3 trial (The ASTER Study) The AZALEA-TIMI 71 trial in patients with atrial fibrillation (AF) also remains ongoing after […]
Anthos Therapeutics Appoints Drew Young as Chief Commercial Officer and Head of Patient Experience
CAMBRIDGE, Mass., May 26, 2022 /PRNewswire/ — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced the appointment of Drew Young as Chief Commercial Officer and Head of Patient Experience. Mr. Young is joining Anthos at a very exciting time in the company’s young history, bringing over 25 years of commercial and […]