Inclisiran

V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1 A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1 Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone1 The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment1-4 EAST HANOVER, N.J., April 6, 2024 /PRNewswire/ -- Novartis today announced new data demonstrating the early addition of twice-yearly* Leqvio® (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone1. The late-breaking data were presented at the 2024 American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the Journal of the American College of Cardiology. "V-INITIATE evaluated a solution to the important challenge seen in clinical practice of too many patients with ASCVD not achieving guideline-recommended LDL-C goal on statins alone and effective non-statin therapies being markedly underutilized," said Michael Koren, M.D., Medical Director and CEO of Jacksonville Center for Clinical Research, and the primary investigator of the study. "Given the urgent need to more aggressively manage LDL-C, the results from V-INITIATE show that when added earlier in the treatment continuum, the structured use of effective non-statin therapies like Leqvio can significantly reduce LDL-C for ASCVD patients who are struggling to reach or maintain their LDL-C goal." In the V-INITIATE study, patients receiving Leqvio experienced significant reductions in LDL-C compared to those receiving usual care (60% vs. 7%, respectively; p<0.001), which consisted mostly of statin therapy alone (73%)1. Four in five patients receiving Leqvio achieved the guideline-recommended LDL-C goal of <70 mg/dL compared to just one in five patients receiving usual care (81.8% vs. 22.2%, respectively; p<0.001)1. Notably, patients receiving health care provider (HCP)-administered Leqvio maintained adherence to existing lipid-lowering therapy, and the discontinuation rate of background statin therapy did not differ between the Leqvio and usual care arms (5.8% vs. 16.7%, respectively)1. The safety results from V-INITIATE were consistent with findings from the pivotal Phase III clinical trial program and long-term open-label extension trials, ORION-3 and ORION-8, which demonstrated sustained safety for up to six years of treatment1-4. "The data from V-INITIATE illustrate that earlier initiation of innovative non-statin therapies, like Leqvio, presents a real opportunity to do better for ASCVD patients and improve the way we approach LDL-C lowering," said David Soergel, M.D., Global Head of Cardiovascular, Renal and Metabolic Drug Development at Novartis. "This study adds data from a real-world setting to the growing body of evidence for Leqvio being generated through our robust VictORION program, and further reinforces the clinical value of this twice-yearly HCP-administered therapy." V-INITIATE is a 12-month Phase IIIb open-label study evaluating the effectiveness of adding Leqvio earlier, following a patient's failure to reach LDL-C goal on maximally tolerated statin therapy, compared to usual care, in a setting that reflects U.S. clinical practice. It was designed to more accurately represent the diversity of the U.S. general population across age, sex, race, ethnicity, insurance status, income level, education, prior medical history and statin intolerance1. Unlike placebo arms in typical double-blind trials, the usual care arm reflected U.S. clinical practice by allowing treating physicians to make changes to lipid-lowering treatment based on LDL-C measurements. Usual care was defined as clinician determined based on the 2018 American College of Cardiology/American Heart Association guideline recommendations1. *After an initial dose and another at three months. Indication LEQVIO (inclisiran) is an injectable prescription medicine used along with diet and other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein (LDL-C) or "bad" cholesterol. Important Safety Information: The most common side effects of Leqvio were: injection site reaction (including pain, redness, and rash), arthralgia (joint pain), bronchitis (chest cold). These are not all the possible side effects of Leqvio. Ask your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Please click here for Leqvio full Prescribing Information. About Leqvio Leqvio is a subcutaneous injection given by a health care provider (HCP) with an initial dose, another at three months, and then every six months2,5. As a twice-yearly, HCP-administered treatment, Leqvio may help to circumvent the challenges of treatment adherence, a common issue in cholesterol management. Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 90 countries, including the U.S., EU, Japan and China1,5,6. Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics. About V-INITIATE V-INITIATE is a 12-month, randomized, multicenter, open-label Phase IIIb study in 450 atherosclerotic cardiovascular disease (ASCVD) patients in the U.S. with elevated LDL cholesterol (LDL-C) ≥70 mg/dL. The study evaluated the effectiveness of adding HCP-administered Leqvio earlier, following a patient's failure to reach LDL-C goal on maximally tolerated statin therapy, compared to usual care1. Usual care was determined by the clinicians and based on the 2018 American College of Cardiology/American Heart Association guideline recommendations; most patients (73%) in the usual care arm remained on statins only1. The co-primary endpoints were the percentage change in LDL-C from baseline to Day 330 and the discontinuation of statin therapy, defined as no statin use ≥30 days before the end of study visit1. This is the first Novartis trial where all patients have been tokenized with the intention of following their outcomes for two additional years post-trial completion, providing additional insights on the real-world effectiveness of Leqvio7. About VictORION The V-INITIATE trial is part of VictORION, an innovative and robust clinical program for Leqvio, comprising more than 30 trials and enrolling over 60,000 patients in more than 50 countries worldwide7. The program is designed to expand on the foundational evidence of LDL-C reduction with Leqvio in diverse patient populations to include randomized clinical trials, implementation research, real-world evidence, and trials that aim to establish its potential benefits on cardiovascular outcomes in primary and secondary prevention. A growing number of studies are planned to generate a vast array of data with major trials such as ORION-4 (secondary prevention), V(VictORION)-2-PREVENT (secondary prevention), V-1-PREVENT (high-risk primary prevention), V-INCEPTION and V-MONO. About Atherosclerotic Cardiovascular Disease (ASCVD) ASCVD refers to a variety of diseases caused by the development and growth of plaques in the inner lining of the arteries8. The atherosclerotic plaque is mainly composed of low-density lipoprotein cholesterol (LDL-C) which accumulates over time8. Cumulative exposure to LDL-C is proportionally related to arterial plaque growth and progression leads to subsequent risk of cardiovascular events such as a heart attack or stroke8,9. Accounting for 85% of all cardiovascular disease deaths, ASCVD is the primary cause of mortality in the European Union and its burden in the United States is greater than that of any other chronic diseases10-13. ASCVD risk-equivalent corresponds to conditions that confer a similar risk for an ASCVD event (e.g., diabetes and heterozygous familial hypercholesterolemia)4,13. About Novartis in Cardiovascular Cardiovascular disease (CVD) affects hundreds of millions of people and claims more lives globally than cancer, chronic lung disease and diabetes combined14. It is time to change that. Around 80% of premature cardiovascular deaths can be prevented by addressing factors that cause or worsen CVD15. We have a responsibility to make that a reality for more people. Novartis has been advancing the scientific understanding and treatment of CVD for more than four decades. Through early intervention, pioneering science and technological innovation, we are addressing factors that increase the risk of heart attacks and strokes, improving the function of damaged hearts and easing the burden of care for patients. We also collaborate with healthcare professionals, patient communities and diverse organizations to improve preventive CV care worldwide. Together, we will help more people with CVD get the right treatments at the right time and live longer and healthier lives. Disclaimer This 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 the investigational or approved products described in this press release, or regarding potential future revenues from such products. 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 the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, 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 and and connect with us on LinkedIn, LinkedIn US, Facebook, X/Twitter, X/Twitter US and Instagram. Novartis previously filed its 2023 annual report with the Swiss SIX exchange in Switzerland, as well as its 2023 Annual Report on Form 20-F with the US Securities and Exchange Commission, and posted these documents on . Novartis shareholders may receive a hard copy of either of these documents, each of which contains our complete audited financial statements, free of charge, upon request. References Koren MJ, Rodriguez F, East CA, et al. Comparison of an "inclisiran first" strategy with usual care in patients with atherosclerotic cardiovascular disease: results from the VICTORION-INITIATE randomized trial. Data presented at: American College of Cardiology Congress; April 6, 2024; Atlanta, GA. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp. Wright RS, Raal FJ, Koenig W, et al. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. Data presented at: European Society of Cardiology Congress; August 28, 2023; Amsterdam, the Netherlands. Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109-119. European Medicines Agency. Leqvio (inclisiran): An overview of Leqvio and why it is authorized in the EU. Last updated June 2021. Accessed March 12, 2024. National Medical Products Administration. Drug approval document delivery information. Published August 24, 2023. Accessed March 12, 2024. Data on file. NCT04929249. Novartis Pharmaceuticals Corp; 2024. Goldstein JL, Brown MS. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161(1):161-172. Ference BA, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids on cardiovascular health: JACC Health Promotion Series. J Am Coll Cardiol. 2018;72(10):1141-1156. World Health Organization. Cardiovascular diseases (CVDs). Published June 11, 2021. Accessed March 12, 2024. (cvds) Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2012 update: a report from the American Heart Association. Circulation. 2012;125(1):e2-e220. Kim H, Kim S, Han S, et al. Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors in Korea: a nationwide population-based study. BMC Public Health. 2019;19(1):1112. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139:e1082–e1143. American Heart Association. More than half of U.S. adults don't know heart disease is leading cause of death, despite 100-year reign. Published January 24, 2024. Accessed March 12, 2024. World Heart Federation. World Heart Report. Published May 20, 2023. Accessed March 12, 2024. # # # SOURCE Novartis Pharmaceuticals Corporation

作为掌舵手，首席执行官（CEO）薪酬往往与公司业绩紧密相关。一般而言，当药企营收实现稳健增长时，CEO往往会获得更丰厚的薪酬回报，否则不仅无法获得额外激励，还有可能面临“下课”的风险。比如2023年强生在肿瘤免疫业务的驱动下强势回归营收榜首，其CEO薪酬就水涨船高，达到了2840万美元。本文汇总了2023年制药巨头CEO薪酬情况，供大家参考。具体来看，强生、礼来、阿斯利康、GSK、诺华、诺和诺德CEO薪酬与去年相比增长强劲，涨幅超过20%。辉瑞、艾伯维和赛诺菲CEO的薪酬则因公司业绩不达预期，出现下降。而罗氏、拜耳和BMS的CEO刚刚履新，具体工作成果尚未展现，长期激励或许过些时日才能兑现。强生 Joaquin DuatoJoaquin Duato自2022年1月起开始担任强生CEO，2023年1月起兼任董事会主席。强生在一份SEC文件中披露，2023年Duato取得了2839.72万美元的薪酬，与2022年相比翻倍增长，主要来自于股票激励和养老金的大幅提高。强生表示，在Duato的领导下，公司2023年基本达到或超过了其综合财务和战略目标，董事会决定给予Duato的年度绩效奖金为目标金额的130.4%，长期奖励为目标金额的125.0%。礼来 David RicksDavid Ricks在礼来工作已经超过25年，2017年起开始担任公司CEO兼董事会主席。礼来在SEC文件中披露，2023年Ricks薪酬为2656.57万美元，同比增长24%。礼来表示，在Ricks的领导下，2023年公司基本达到或超过了财务和战略目标。礼来2023年营收341.24亿美元（+20%），替尔泊肽（Mounjaro）上市两年销售额达到了51.63亿美元（+970%），增势迅猛。艾伯维 Richard GonzalezRichard Gonzalez自2013年起开始担任艾伯维CEO，2023年薪酬为2566.20万美元，与2022年的2630万美元相比略有下降。据悉，Richard Gonzalez将从首席执行官的职位上退休，并成为董事会执行主席，自2024年7月1日起生效。首席运营官Robert A. Michael升任CEO。艾伯维2023年营收543.18亿美元，较往年有所下滑（-6.4%）。昔日为艾伯维支柱产品的药王Humira销量急速下滑（-32.2%），销售额仅有144.04亿美元，极大影响了公司整体表现。吉利德 Daniel P. O’DayDaniel P. O’Day自2019年3月起开始担任吉利德CEO兼董事会主席，2023年薪酬为2260.77万美元，同比增长5%。据悉，Daniel P. O’Day加入吉利德后，已连续多年涨薪。2023年，在Daniel P. O’Day的领导下，吉利德总营收269亿美元，与2022年持平，去除瑞德西韦的影响，产品收入同比增长7%。其中近些年重点关注的肿瘤板块合计销售29.3亿美元，同比增长35%。辉瑞 Albert BourlaAlbert Bourla在1993年加入辉瑞，2019年1月起开始担任CEO，2020年1月起担任董事会主席，2023年取得了2156.21万美元的薪酬，与2022年的3301.75万美元相比下滑35%，主要是因为非股权激励从765万美元降至0。Albert Bourla薪酬缩水并不令人意外。2023年由于新冠产品销售额严重萎缩，辉瑞业绩下滑41%，远远不达公司预期，此外股价也暴跌了44%。阿斯利康 Pascal SoriotPascal Soriot自2012年10月1日起开始担任阿斯利康CEO兼董事会执行董事，2023年薪酬为1685.3万英镑（约合2103万美元），与2022年相比涨薪12%。在Pascal Soriot的领导下，阿斯利康2023年收入458亿美元，高于此前设定的450亿美元营收目标。根据阿斯利康最新报告，Pascal Soriot大部分薪酬来自与他在创新、股东回报和环境可持续发展等领域的表现挂钩的长期激励。葛兰素史克 Emma WalmsleyEmma Walmsley在2010年加入葛兰素史克（GSK），2017年1月起开始担任公司CEO，2023年薪酬为1271.8万英镑（约合1587万美元），与2022年的844.9万英镑相比，涨薪51%。GSK在报告中表示，Emma Walmsley超额完成了目标。2023年GSK营收增长14%，是7%目标增长率的2倍，且超过了内部利润增长目标。诺华 Vasant NarasimhanVasant Narasimhan在2005年加入诺华，自2018年起开始担任公司CEO，2023年薪酬为1327.06万瑞士法郎（约合1483.25万美元），与2022年相比涨薪21%，其中增幅最大的是与公司业绩挂钩的年度激励。在Narasimhan的领导下，诺华2023年财务表现出色，Entresto、Kesimpta、Kisqali、Leqvio和Pluvicto等产品销售额均超过目标。此外，诺华还达成了多起交易，在研发上也取得突破性进展，并且成功剥离了山德士。赛诺菲 Paul HudsonPaul Hudson自2019年9月1日起开始担任赛诺菲CEO。此前，他在诺华担任CEO。根据赛诺菲文件，Paul Hudson在2023年取得了1057.18万欧元（约合1146万美元）薪酬，与2022年相比略微下降。在Paul Hudson的领导下，赛诺菲2023年销售增长、净利润、自由现金流、利润率和新资产增长五个指标均超额完成，其个人目标也已完成。基于此，Paul Hudson可变薪资比2022年增加了4.2万欧元，但股权奖金有所下降。罗氏 Thomas SchineckerThomas Schinecker在2023年3月14日被任命为罗氏CEO，此前他在罗氏诊断部门担任负责人。上任第一年，Thomas Schinecker获得了960.58万瑞士法郎（约合1074万美元）的薪酬收入。2023年罗氏全年营收587.16亿瑞士法郎，同比增长1%（按CER计算），净利润123.58亿瑞士法郎，同比增长7%。肿瘤业务在连续多年下滑后首次实现增长，为公司贡献了190.87亿瑞士法郎（+4%）的收入。诺和诺德 Lars Fruergaard JørgensenLars Fruergaard Jørgensen在1992年加入诺和诺德，并于2017年1月起开始担任公司CEO。2023年在诺和诺德强劲业绩的加持下，Lars Fruergaard Jørgensen涨薪13%，达到了6820万丹麦克朗（约合991.63万美元）的薪酬。诺和诺德报告表示，Lars Fruergaard Jørgensen达到了公司很高的期望。在他的带领下，诺和诺德2023全年收入2322.61亿丹麦克朗（约337.71亿美元，+31%），营业利润为1025.74亿丹麦克朗（约149.14亿美元，+37%）。百时美施贵宝 Christopher S. BoernerChristopher S. Boerner自2023年11月开始担任百时美施贵宝（BMS）CEO，此前他在公司担任首席商务官。根据报告，Christopher S. Boerner在2023年共取得了846.18万美元薪酬。BMS前CEO Giovanni Caforio薪酬为1966万美元，与往年相比略有下降。未来，Chris Boerner希望公司能顺利度过20年代后半段充满专利悬崖和新的政府强制定价压力时期。拜耳 Bill AndersonBill Anderson在2023年4月才加入拜耳，同年6月1日起开始担任公司CEO。此前他在罗氏担任CEO。根据拜耳报告，Bill Anderson在2023年取得了649.2万欧元（约合704万美元）的薪酬，其中绝大部分为附加福利，包括定期健康检查、保险政策、公司用车配司机/相应预算、私人住宅的安全装置等。Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。