The Anthos Group

Blackstone Life Sciences and Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiometabolic diseases, announced today that Novartis has completed its acquisition of Anthos Therapeutics in a transaction valued at up to $3.1 billion. Anthos was founded by Blackstone Life Sciences and Novartis in 2019 with the exclusive global rights from Novartis to develop, manufacture, and commercialize abelacimab, a novel Factor XI inhibitor that originated at Novartis. Abelacimab is currently in Phase 3 clinical development for the prevention of stroke and systemic embolism in patients with atrial fibrillation (LILAC-TIMI 76), in addition to two phase 3 studies in patients with cancer-associated thrombosis (ASTER and MAGNOLIA). Data from these trials are expected in the second half of 2026. Anthos shareholders will receive up to $3.1 billion in total deal value, including an upfront payment of $925 million, and payments in the event certain regulatory and commercial milestones are achieved. Goldman Sachs & Co. LLC acted as the lead financial advisor to Anthos. Morgan Stanley & Co. LLC also served as a financial advisor, and Goodwin Procter LLP served as legal advisor to Anthos. Blackstone Life Sciences (BXLS) is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, BXLS helps bring to market promising new medicines and medical technologies that improve patients’ lives and currently has $12 billion in assets under management. Founded by BXLS in 2019, Anthos Therapeutics is a transformative, clinical-stage biopharmaceutical company with exclusive global rights from Novartis Pharma AG to develop, manufacture and commercialize abelacimab. BXLS was the majority investor in the company, joined by other partners including Novo Holdings. For more information about Anthos, visit the Company’s website. Abelacimab 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. 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.

关注并星标CPHI制药在线 2月11日，诺华宣布，以31亿美元交易总价收购Anthos Therapeutics（下称Anthos）。该笔交易中，诺华将支付9.25亿美元的预付款，并在达到规定的监管和销售里程碑后可能额外支付高达21.5亿美元。该交易预计将于2025年上半年完成。 值得关注的是，Anthos和诺华本就有密切关系，而且Anthos仅有的一款核心管线abelacimab原本由诺华注入。那么，如今诺华为何要回收这款药物？ 始于诺华，回归诺华 2019年，黑石集团（Blackstone）旗下的生命科学基金Blackstone Life Sciences与诺华共同创立Anthos Therapeutics，这是一家专注于心血管疾病治疗的临床阶段生物制药公司。其仅有的一款核心管线abelacimab，由诺华授权，Anthos负责开发、制造和商业化，诺华则获得Anthos的部分股权，这一模式与今天国内大火的"NewCo"类似。 Abelacimab是一款靶向凝血因子FXI/FXIa的单抗，在开发早期，诺华由于风险控制等因素，选择与黑石集团合作，成立Anthos Therapeutics，并将Abelacimab剥离到该公司。由黑石主导早期开发。 在II期临床AZALEA-TIMI 71研究中，Abelacimab取得了积极结果。该研究共有1287名房颤患者入组，患者按1：1：1的比例随机分组，并皮下给予每月一次90 mg、150 mg abelacimab，或每日一次20 mg活性对照药物。研究显示，在房颤患者中，与标准治疗的直接口服抗凝药（DOAC）相比，Abelacimab在所有主要和次要终点上均显著降低了出血事件。每月皮下注射一次150毫克Abelacimab可降低凝血因子XI水平达99%，效果可持续2年以上。而且abelacimab显著超预期地减少了出血事件。 目前，Anthos已开始进行Abelacimab的III期试验，入组患者为不适合口服抗凝治疗的高危房颤患者，数据可能会在2026年公布。 也许是看到Abelacimab的成药潜力，诺华决定收购Anthos，拿回abelacimab的权益。黑石得以成功退出，并收获丰厚回报，可谓双赢。 更安全的抗凝剂靶点：凝血因子XI（FXI） 血栓，是大多数心肌梗死、缺血性脑卒中和静脉血栓栓塞症（VTE）的共同病理基础，抗凝药物是预防和治疗血栓的基石。 目前临床常用的抗凝药物主要有直接口服抗凝剂（DOAC）、维生素K拮抗剂（VKA）等。VKA的代表药物是华法林，DOAC则包括利伐沙班、阿哌沙班与艾多沙班等。十多年来，靶向凝血酶或凝血因子(FXa)的DOAC作为一种新型口服抗凝剂被开发和应用，以取代VKA。但是尽管DOAC在有效性和安全性等方面存在诸多优势，但其抗凝治疗的代价是出血风险的增加。因此，需要找到出血风险更小的抗凝药物。 研究表明，FXI在血栓形成中至关重要，但在大多数情况下对正常止血并非必需。比如具有遗传性FXI缺乏的人群，血栓事件的发生率明显降低，而自发性出血的风险并未显著增加。因此，FXI抑制剂有望实现血栓形成与止血功能的分离，为抗凝治疗提供更安全的选择。目前，多种FXI抑制剂正在开展临床试验。 药企围猎FXI抑制剂 据悉，2026年，BMS将会失去核心抗凝产品阿哌沙班的专利独占权。该药物2021年销售额为108亿美元，占比BMS全年收入23%，是其当之无愧的支柱产品。对此，BMS和强生联合开发了口服FXIa抑制剂Milvexian，目前处于临床III期试验阶段，评估其用于房颤、急性冠脉综合征以及中风患者中的作用。 再生元在FXI抑制剂领域布局了两款产品REGN7508和REGN9933，这两款抗体药物具有独特的作用机制，其中REGN7508靶向FXI催化结构域，旨在最大限度地提高抗凝活性，同时将出血风险降至最低；REGN9933靶向FXI蛋白A2结构域，则为那些具有最高出血风险且不适合现有抗凝药物的患者提供了额外选择。 在II期临床研究中，两者均表现出显著的抗血栓效果，且未观察到与治疗相关的临床显著出血事件。目前，公司已计划将这两款抗体推进III期临床开发阶段。 拜耳的口服抗凝FXIa抑制剂asundexian已进入III期临床，不过由于asundexian在预防中风方面的数据劣于辉瑞的阿哌沙班，该临床试验被提前终止。 在国内，仁会生物，康宁杰瑞，博槿生物，甘李药业、恒瑞医药等也在开发这一领域。恒瑞医药于2月12日，刚刚启动其抗凝药SHR-2004的首个III期临床试验。SHR-2004是一种靶向FXI的人源化单克隆抗体，可选择性结合FXI和FXIa，阻碍凝血因子XIIa（FXIIa）对FXI的激活，从而阻断内源性凝血途径的级联反应过程，发挥抗凝作用。临床前研究显示，SHR-2004可以延长活化部分凝血活酶时间，抑制FXI活性。 心血管和代谢疾病一直是全球首要死因，据WHO估计，全球死亡人群中超过1/4死于动脉血栓栓塞，并且在过去20年中发病率急剧上升。因此抗凝药物市场规模巨大。2024年阿哌沙班全球销售额达133.33亿美元，另一款重磅抗凝药物利伐沙班的全年销售额达65亿美元。 此次诺华回收的abelacimab作为抗体药物，不仅安全性更佳，且与阿哌沙班等相比，避免了小分子药物通过肝肾代谢的途径，减少了药物间的相互作用和个体差异。而且在用药周期方面，abelacimab每月仅需一次静脉注射，而阿哌沙班与利伐沙班需要每日口服，从而提高了患者依从性与便利性。若III期临床成功，abelacimab或可搅动抗凝江湖。 主要参考资料：        1、Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront. 2、Raffaele De Caterina, Domenico Prisco, John W Eikelboom. Factor XI inhibitors: cardiovascular perspectives Get access Arrow. 2023, 44(4): 280-292. 3、https://ottimopharma.com/ottimo-pharma-raises-over-140-million-in-series-a-financing/.        扫码领取CPHI & PMEC China 2025展会门票 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

On February 11, Novartis announced its first acquisition of the year, acquiring Anthos Therapeutics for an upfront payment of $925 million and an additional $2.15 billion in milestone payments. This strategic move aims to strengthen Novartis's position in the cardiovascular sector. Interestingly, Anthos Therapeutics has a close historical connection with Novartis. Founded in collaboration with Blackstone Group in 2019, the company's founding CEO, John Glasspool, previously served as the global head of cardiovascular at Novartis. Notably, the key product in Anthos's pipeline, abelacimab (MAA868), a monoclonal antibody targeting coagulation factor FXI/FXIa, was also licensed from Novartis. Abelacimab represents a groundbreaking advancement in anticoagulant therapy, effectively reducing thromboembolic risks without increasing bleeding risks. This addresses a significant concern, as many atrial fibrillation patients are hesitant to use oral anticoagulants due to bleeding fears. The AZALEA-TIMI 71 trial, a pivotal study for abelacimab, demonstrated its superiority over traditional anticoagulants like rivaroxaban, showing a 62% reduction in major bleeding events. The study's early termination due to overwhelming effectiveness underscores the drug's potential impact. Novartis’s decision to authorize abelacimab to Anthos initially was likely a calculated risk, balancing opportunity costs and risk management. Rather than losing a promising drug to potential failure, Novartis opted to leverage external funding for its development while retaining control over its future. With this acquisition, Novartis is not only reclaiming abelacimab but also enhancing its cardiovascular portfolio, which includes the well-established heart failure medication Entresto and the rapidly growing cholesterol-lowering drug Inclisiran. Abelacimab could potentially fill a critical gap in their product line, targeting atrial fibrillation and thereby addressing a broader patient demographic. Novartis's acquisition of Anthos Therapeutics is a strategic move that reinforces its commitment to advancing cardiovascular treatments and addressing unmet medical needs in this critical therapeutic area.