IQVIA Ltd.

PHILADELPHIA, Sept. 4, 2024 /PRNewswire/ -- Signant Health, the leader in evidence generation for modern clinical trials, announced today it has joined IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, in its One Home for Sites™ initiative. IQVIA One Home for Sites is an industry-wide collaboration designed to simplify site conduct when clinical research staff leverage multiple eClinical technologies from multiple solution providers on a trial. Through single sign-on to a common platform, sites enjoy simplified access to trial technologies from IQVIA and other technology partners that have taken the steps to participate in One Home. One such technology solution that will appear on the One Home for Sites platform is Signant SmartSignals® Unified Platform, itself a fully integrated solution consisting of eCOA, EDC, RTSM, eConsent, and telemedicine. "We are very pleased to have our Unified Platform now available within One Home for Sites," said Sanjiv Waghmare, Signant's chief product officer. "IQVIA's industry-wide, collaborative approach aligns well with our overall product strategy to homogenize access to all our products through a single environment we call Signant SmartSignals® ID Portal. We applaud IQVIA's efforts to extend this philosophy by consolidating multiple solution providers into one ecosystem for easy access by sites." "Signant Health quickly recognized the power of One Home for Sites to capture synergies across the industry and deliver a better experience to sites," said Melissa Easy, VP of Commercialization for IQVIA Technologies Digital Products and Services. "We welcome Signant to One Home and look forward to their continued contribution to building the next-generation clinical trial ecosystem that benefits all stakeholders – especially the patients we serve." About Signant Health Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at . About IQVIA IQVIA (NYSE: IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA's portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA's insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit . Contact: Heather Bilinski [email protected] +1 610.400.4141 SOURCE Signant Health

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- IQVIA Holdings Inc. (“IQVIA”) (NYSE:IQV), announced today that Ron Bruehlman, executive vice president and chief financial officer, will speak at the Credit Suisse Annual Healthcare Conference in Rancho Palos Verdes on Tuesday, November 8, 2022 at 12:10 p.m. ET (9:10 a.m. PT). A live audio webcast of the presentation will be available on the IQVIA Investor Relations website at . A replay of the webcast will be available later that day. About IQVIA IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 83,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit . IQVIAFIN View source version on businesswire.com: Contacts Nick Childs, IQVIA Investor Relations (nicholas.childs@iqvia.com) +1.973.316.3828 Trent Brown, IQVIA Media Relations (trent.brown@iqvia.com) +1.919.780.3221 Source: IQVIA Holdings Inc. View this news release online at:

导 读近年来，尽管药物研发面临着研发成本高昂和后期临床试验成功率较低等多重挑战，CNS（中枢神经系统）领域的药物交易仍快速上升，在生命科学领域交易市场占据了一席之地。值得注意的是，随着神经科学候选药物成为驱动交易的关键，2020-2021年CNS领域的交易量大幅增加，尤其是新型治疗形式和给药方法。1早期研发合作推动2021年CNS交易的发展2017-2019年，神经科学领域的交易数量稳步增长，直至2020年略有下降。这一变化可能是由于COVID-19大流行期间，资源更多地转移到传染病领域。随着疫苗的成功推广和COVID-19病例的减少，CNS领域交易在2021年开始恢复，交易量激增，共达成了277项交易。突破性技术和模式的快速发展（如新型给药方法和基于核苷酸的疗法）对此功不可没。尽管所涉及的技术仍处于早期研发阶段，但它们能够使疗法穿过血脑屏障，更顺利地进入中枢神经系统。就具体适应症而言，涉及治疗多发性硬化症和阿尔茨海默症的药物交易在2021年激增，这是由于受影响的人口众多且医疗需求高。2近期主要CNS交易2021年有许多高价并购交易与神经系统疾病相关，如Jazz Pharmaceuticals以72亿美元收购了GW Pharmaceuticals；Horizon Therapeutics以30.5亿美元收购Viela Bio，但这些交易并非特定集中在某一个CNS领域。相反，只专注于CNS适应症的最大并购交易是Angelini Pharma对Arvelle Therapeutics的收购，总估值高达9.6亿美元。通过该交易，Angelini获得了塞诺氨酯，一种用于成人局灶性（部分发作）癫痫发作的抗癫痫药物，该药物最近在欧洲以Ontozry®的品牌名上市。同样受抗癫痫治疗的推动，uniQure以2.5亿欧元收购了Corlieve Therapeutics，获得了Corlieve主导的AMT-260项目，这是一种利用miRNA沉默技术治疗颞叶癫痫（最常见的局灶性癫痫形式）的基因疗法。Supernus Pharmaceuticals在2021年以4.5亿美元收购了Adamas Pharmaceuticals，获得了两种获批用于帕金森病患者的药物。该交易为Supernus获得了Gocovri（金刚烷胺）缓释胶囊，该产品在美国被批准用于治疗接受左旋多巴治疗的帕金森病患者的“关闭期”发作和运动障碍。Supernus还将获得Osmolex ER（金刚烷胺）缓释片的权利，该药在美国被批准用于治疗帕金森病和药物引起的成人锥体外系反应。尽管2021年的并购交易活动有所上升，但制药公司仍然倾向于与EBP（新兴制药公司）进行大量合作交易，依靠他们进行早期研发，在有一定进展后再接管。表1显示了IQVIA Pharma Deals平台选出的值得注意的高价值CNS合作交易。由于分析中包括了许可和合作交易，总交易价值取决于实现特定的研发和临床里程碑付款。所有公开的预付费用都已列在表中，帮助企业更好地衡量交易条款。 按潜在交易总额计算，2021年最大的交易是罗氏与Shape Therapeutics为阿尔茨海默病、帕金森病和罕见疾病领域研发基因疗法而达成的合作，总金额超30亿美元。通过合作，两家公司计划利用Shape Therapeutics的新型RNA编辑平台RNAfix™和AAVid™技术平台进行临床研究，研发下一代组织特异性腺相关病毒（AAVs）。另一项就核苷酸技术达成高价交易的是武田与Anima Biotech，总金额可达24亿美元。两家公司达成合作，利用后者的翻译控制治疗平台，研发用于遗传性神经疾病的mRNA转化调节剂。临床前的研究合作将首先包括Anima针对HTT（亨廷顿）靶点的早期亨廷顿病项目。2021年，预付金额最大的许可权交易是葛兰素史克出资7亿美元与Alector合作，共同研发两种临床阶段的单克隆抗体，用于治疗神经退行性疾病。这笔交易的重点关注于“免疫神经学”这一新研究领域，探索利用人体的先天免疫系统治疗神经退行性疾病的方法。诺华与优时比就神经科学领域达成1.5亿美元预付交易的合作，共同研发UCB0599，一种小分子α-突触核蛋白错误折叠抑制剂，目前已处于帕金森病临床Ⅱ期研究阶段。辉瑞在与Biohaven Pharmaceutical的交易中也承诺提供1.5亿美元的预付款，以获得CGRP（降钙素基因相关肽）受体拮抗剂、偏头痛药物rimegepant和zavegepant的商业化权利。rimegepant于2022年4月获得欧盟委员会的上市许可，用于偏头痛的急性和预防性治疗，成为同类产品中的首个获批药物。2022年5月，辉瑞以116亿美元的交易总额收购Biohaven，获得了偏头痛药物的全球权利。该交易也成为了2022年迄今为止最大的生物制药并购案。除此之外，艾伯维斥资10亿美元收购Syndesi以获得SDI-118，一项用于治疗认知障碍的Ⅰb期管线。此外，一些备受瞩目的合作交易也已宣布，包括赛诺菲与ABL Bio达成全球合作许可协议，推进ABL301治疗帕金森病研究。3CNS发展前景尽管CNS疗法面临着许多挑战，医药公司仍继续大力投资该领域的新技术和模式。2021年交易数量的上升反映了神经科学领域日益增多的需求，这反过来又推动了交易结构中的风险分配。随着对疾病与人脑机制的了解更为深入，治疗市场将不断扩大，交易数量和交易额也将继续增长。可以预见，2022年CNS的交易活动或将继续保持去年的规模。