Bosentan

Aprocitentan, on top of background therapy, showed clinically meaningful and durable blood pressure (BP) reduction and a decrease in proteinuria in Black patients with confirmed resistant hypertension Allschwil, Switzerland – April 9, 2025 Idorsia Ltd (SIX: IDIA) today announced the publication of "Aprocitentan for Blood Pressure Reduction in Black Patients” in the April edition of Hypertension1. The publication reports preplanned analyses of the efficacy, tolerability and safety of aprocitentan – Idorsia’s once-daily, orally active, dual endothelin receptor antagonist – in the subgroup of African American patients enrolled in the Phase 3 PRECISION study2 in patients with confirmed resistant hypertension. Aprocitentan, when added to a combination of at least three antihypertensive drugs (four in more than 50% of patients), produced clinically meaningful and sustained blood pressure reductions.1 Aprocitentan also markedly decreased proteinuria in the patients with proteinuria at baseline.1 As reported by the authors, aprocitentan was safe and well tolerated, even in those Black patients with chronic kidney disease.1 Hypertension is the leading modifiable cause of early mortality and cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally.3 Approximately 10% of these people have uncontrolled BP, despite receiving at least three antihypertensive medications from different classes, at optimal doses.4,5 Compared with adults whose hypertension is well controlled, adults with uncontrolled hypertension have much greater risk of heart attack, stroke, end-stage renal disease and death.6 Black hypertensive individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk.7,8,9 The endothelin (ET) pathway has been implicated in the pathogenesis of hypertension and is activated in patients prone to developing resistant hypertension,10,11 such as Black or African American patients12, patients with obesity13 or obstructive sleep apnea,14 and in comorbid conditions frequently associated with resistant hypertension such as diabetes15,16 and chronic kidney disease.17,18 Prof. Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA Professor, Tulane University School of Medicine, Tulane Heart & Vascular Institute, US, co-author of the publication and investigator in the PRECISION study, commented: “Black individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk. This is possibly related to the activated endothelin system seen in patients prone to developing resistant hypertension and this may explain why existing therapies that do not target the endothelin system have not shown optimal improvement for Black patients. Now, for the first time, we have an approved treatment targeting the endothelin system that may help fulfil an unmet need in Black patients with resistant hypertension.” The publication is accompanied by an Editorial entitled “Endothelin Antagonism: A New Era for Resistant Hypertension?”19 from Gavin B. Chapman and Neeraj Dhaun of Edinburgh Kidney, University/BHF Centre for Cardiovascular Science, The Queen’s Medical Research Institute, University of Edinburgh, United Kingdom and Department of Renal Medicine, Royal Infirmary of Edinburgh, United Kingdom (G.B.C., N.D.). The Editorial recognizes that the approval of aprocitentan in the US and Europe represents the first new antihypertensive to be approved in over two decades and the first via a new pathway in almost four decades. In closing, the authors conclude “Given the broad beneficial effects ET receptor antagonism has on a range of cardiovascular risk factors, it may not be long before clinicians reach for these drugs above other, more established antihypertensive medications.”19 Prof. John M. Flack, MD, MPH, FAHA, MACP, CHS, Sergio Rabinovich Endowed Chair of Internal Medicine, Chair Departments of Medicine and Population Science and Policy, Southern Illinois University School of Medicine, Lead author of the publication and investigator in the PRECISION study, commented: “The salt-sensitive, low-renin, hypertension often seen in Black patients makes their hypertension difficult to control and increases their cardiovascular risk. In fact, Black adults with hypertension less often achieve the guideline recommended BP goals, leading to an estimated 400,000 strokes, heart attacks and other cardiovascular events that could be prevented over 10 years if blood pressure control could be achieved. In PRECISION, the effect of aprocitentan for these patients was striking and I agree with the Editorial in suggesting that we are entering a new “era” for resistant hypertension, as with aprocitentan, the dual endothelin receptor antagonist or “ERA”, we can now tackle this important pathway.” Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not adequately controlled on other drugs, and has been commercially available since October 2024.20 Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with other antihypertensives in the European Union21 and the UK and marketing authorization applications are under review in Canada and Switzerland. Notes to the editor About Prof. Ferdinand Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA began his medical career with a BA in biology from the University of New Orleans. He then went on to earn an MD from Howard University College of Medicine in Washington, DC, an internship at the US Public Health Hospital in New Orleans, an internal medicine residency and cardiology fellowship at LSU Medical Center and a cardiology fellowship at Howard University Hospital, Washington, D.C. After years of doing clinical work, research and teaching at Xavier University, LSU, Baylor College of Medicine, and Emory University, Dr. Ferdinand returned to New Orleans as a Professor of Clinical Medicine at the Tulane University Heart and Vascular Institute. Dr. Ferdinand has been heavily involved in many national organizations concerned with public health, including the Association of Black Cardiologists, of which he was the former Chair and Chief Science Officer, the American Society of Hypertension, of which he was a board member, and the Healthy Heart Community Prevention Program, a cardiovascular risk program targeting African American and other high-risk populations. He is the immediate-past Chair of the National Forum for Heart Disease and Stroke Prevention, which provides the leadership and encouragement for collaboration among over 65 organizations. Dr. Ferdinand focuses largely on cardiac risk factor evaluation and control, especially hypertension and hyperlipidemia, including communities of racial and ethnic minorities. He has had over 100 manuscripts published and has a strong media presence. His passion for patient-care is highlighted in his commitment to non-profit work and community service. In 2015 he was inducted into the Association of University Cardiologists. Prof. Ferdinand serves as a consultant to Idorsia. About Prof. Flack John M. Flack, M.D., M.P.H., F.A.H.A., M.A.C.P., an Alpha Omega Alpha (AOA) graduate of the University of Oklahoma School of Medicine, is the Sergio Rabinovich Endowed Chair of Internal Medicine and the Professor and Chair of the Department of Medicine at Southern Illinois University School of Medicine. He is also Chief of the Hypertension Section. He is a board-certified Internal Medicine specialist and an internationally renowned hypertension specialist/cardiovascular epidemiologist with widely recognized clinical/research expertise in hypertension in African Americans, resistant/refractory hypertension, device-based therapies for hypertension and racial cardiovascular health disparities. Dr. Flack is the current President of the American Hypertension Specialist Certification Program. He has published over 210 peer-reviewed manuscripts and book chapters and is an Associate Editor for the American Journal of Hypertension. He maintains an active clinical practice in complex hypertension at SIU where he teaches and mentors medical students and residents and undertakes innovative, cutting-edge research. Dr. Flack has received numerous awards including the Distinguished Research Award (1993) from the International Society on Hypertension in Blacks (ISHIB), the Daniel D. Savage Memorial Scientific Award (1998) from the Association of Black Cardiologist (ABC), the F. Dewey Dodrill Award for Excellence (2007) from the American Heart Association (AHA), the Detroit News Michiganian of the Year (2009), and the University of Oklahoma Academic Physician of the Year (2012). Also, he has been repeatedly named to Top Doctor, Best Doctor, and Super Doctor lists. Previously, he served a stint as a voting member of the FDA Cardio-Renal Advisory Board. Dr. Flack was recently conferred the status of Master by the American College of Physicians (ACP); he also is a current member of the ACP Board of Regents. Prof. Flack serves as a consultant to Idorsia. References About Idorsia Idorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact: Investor & Media Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

关注并星标CPHI制药在线 过去十年，制药与生物技术行业在创新和战略合作的推动下取得了显著增长。其中，并购（M&A）在重塑行业格局中发挥了关键作用，帮助企业加强产品组合、提升研发能力并扩大全球市场覆盖。这些高额交易往往旨在解决未满足的医疗需求、推进治疗管线并开辟新的收入来源。 本文将回顾过去十年中最具影响力的十大制药与生物技术并购案，展示这些交易如何塑造行业未来。从百时美施贵宝（Bristol-Myers Squibb）对新基（Celgene）的巨额收购，到辉瑞（Pfizer）对西雅图基因（Seagen）的收购，这些交易体现了推动生命科学创新的战略与雄心。 1. 百时美施贵宝（BMS）收购新基（Celgene） 交易价值：740亿美元 宣布日期：2019年1月3日 完成日期：2019年11月20日 关键收益： ● 获得了新基的重磅药物Revlimid（来那度胺），这是其肿瘤学产品组合的核心。 ● 获得了创新的CAR-T疗法，如Abecma（idecabtagene vicleucel）。 2019年，百时美施贵宝以现金加股票的方式收购新基，交易价值达740亿美元。这一战略收购显著增强了BMS在肿瘤学、免疫学、炎症和心血管疾病领域的产品组合。 尽管交易中需要剥离部分资产（如将Otezla以134亿美元出售给安进），但这一并购巩固了BMS在肿瘤学和免疫学领域的领先地位。 2. 阿特维斯（Actavis）收购艾尔建（Allergan） 交易价值：705亿美元 宣布日期：2014年11月17日 完成日期：2015年3月17日 关键收益：        ● 获得了艾尔建在眼科、神经科学和医美领域的强大产品组合，如Botox（肉毒杆菌毒素）和Restasis（环孢素）。 阿特维斯以现金加股票的方式收购艾尔建，交易价值达705亿美元。这一并购使阿特维斯转型为全球最大的制药公司之一，覆盖品牌药、仿制药和非处方药（OTC）领域。 3. 艾伯维（AbbVie）收购艾尔建（Allergan） 交易价值：630亿美元 宣布日期：2019年6月25日 完成日期：2020年5月8日 关键收益： ● 获得了艾尔建在医美、神经科学、眼科和胃肠病学领域的领先产品，如Botox和Juvederm。 艾伯维以现金加股票的方式收购艾尔建，交易价值达630亿美元。这一收购旨在多元化艾伯维的收入来源，减少对其旗舰药物Humira（阿达木单抗）的依赖。 4. 武田（Takeda）收购夏尔（Shire） 交易价值：620亿美元 宣布日期：2018年5月8日        完成日期：2019年1月8日 关键收益： 获得了夏尔在罕见病领域的领先疗法，如Xiidra（干眼症治疗药物）和Adynovate（血友病治疗药物）。 武田以现金加股票的方式收购夏尔，交易价值达620亿美元。这一收购使武田成为罕见病、胃肠病学、神经科学和免疫学领域的全球领导者。 5. 辉瑞（Pfizer）收购西雅图基因（Seagen） 交易价值：430亿美元 宣布日期：2023年3月13日 完成日期：2023年12月14日 关键收益： ● 获得了Seagen的ADC产品，如Adcetris（淋巴瘤治疗药物）和Padcev（膀胱癌治疗药物）。 辉瑞以现金方式收购西雅图基因，交易价值达430亿美元。这一收购强化了辉瑞在肿瘤学领域的产品组合，特别是抗体药物偶联物（ADC）技术。 6. 阿斯利康（AstraZeneca）收购亚力兄（Alexion） 交易价值：390亿美元 宣布日期：2020年12月12日 完成日期：2021年7月21日 关键收益： ● 获得了亚力兄的重磅药物Soliris和Ultomiris，用于治疗补体介导的罕见病。 阿斯利康以现金加股票的方式收购亚力兄，交易价值达390亿美元。这一收购标志着阿斯利康进军罕见病领域。 7. 强生（J&J）收购爱可泰隆（Actelion） 交易价值：300亿美元 宣布日期：2017年1月26日 完成日期：2017年6月16日 关键收益： ● 获得了爱可泰隆的PAH药物，如Tracleer、Opsumit和Uptravi。 强生以现金方式收购爱可泰隆，交易价值达300亿美元。这一收购强化了强生在肺动脉高压（PAH）领域的市场地位。 8. 安进（Amgen）收购 Horizon Therapeutics 交易价值：278亿美元 宣布日期：2022年12月12日 完成日期：2023年10月6日 关键收益： ● 获得了Horizon的罕见病疗法，如Tepezza（甲状腺眼病治疗药物）和Krystexxa（慢性痛风治疗药物）。 安进以现金方式收购Horizon Therapeutics，交易价值达278亿美元。这一收购显著增强了安进在罕见病和炎症领域的产品组合。 9. 艾伯维（AbbVie）收购 Pharmacyclics 交易价值：210亿美元 宣布日期：2015年3月4日 完成日期：2015年5月26日 关键收益： ● 获得了Pharmacyclics的重磅药物Imbruvica（依鲁替尼），用于治疗多种血液癌症。 艾伯维以现金加股票的方式收购Pharmacyclics，交易价值达210亿美元。这一收购强化了艾伯维在肿瘤学领域的产品组合。 10. 吉利德（Gilead）收购 Immunomedics 交易价值：210亿美元       宣布日期：2020年9月13日 完成日期：2020年10月23日 关键收益： ● 获得了Immunomedics的ADC技术及其重磅药物Trodelvy，用于治疗三阴性乳腺癌。 吉利德以现金方式收购Immunomedics，交易价值达210亿美元。这一收购显著增强了吉利德在肿瘤学领域的产品组合。 结语 过去十年的制药与生物技术并购浪潮，不仅是资本与资源的整合，更是一场关于创新、战略与未来的深度博弈。这些动辄数百亿美元的交易，映射出行业的核心趋势： ● 创新驱动：从CAR-T疗法到ADC技术，并购成为企业快速获取尖端科技、填补管线空缺的关键手段。 ● 风险对冲：面对专利悬崖与仿制药冲击，巨头们通过收购多元化布局，降低对单一产品的依赖。 ● 聚焦高壁垒领域：罕见病、肿瘤、免疫疾病等高壁垒领域成为并购焦点，推动更多“无药可医”的困境被打破。 然而，高额交易也伴随挑战——巨额债务、整合风险、文化冲突，无一不考验着企业的战略定力。未来，随着基因治疗、AI药物发现等新兴领域的崛起，并购或将更加精准化、技术化，成为行业重塑的常态。 参考资料： 1、https://xtalks.com/category/blogs/life-science-blogs/pharma-blogs/ END 2025金笔奖征文活动开启，来投稿吧！ 领取CPHI & PMEC China 2025展会门票 智药研习社直播预告 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~