Tamsulosin Hydrochloride

WAYNE, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of new research findings from the 2024 American Urological Association Annual Meeting in San Antonio, TX, May 3 – 6, 2024, showcasing excellent patient experience* with the Prostatic Urethral Lift (PUL) with the UroLift™ System for benign prostatic hyperplasia (BPH). This year’s research marks the first time results from two randomized head-to-head trials were presented that reinforce the UroLift™ System as the leading minimally invasive surgical therapy (MIST) that can provide rapid relief and durable outcomes with preservation of sexual function.**1-5 “These significant new randomized head-to-head studies and real-world analyses demonstrate the UroLift™ System provides distinctive patient experience* advantages, positioning it as an early treatment option compared to medications for men whose quality of life is impacted by oppressive BPH symptoms,” said Jacqueline Welch, Vice President of Global Clinical and Scientific Operations at Teleflex. “For over 10 years, Teleflex has advanced BPH research through numerous trials involving the UroLift™ system and now other contemporary treatments. Our continued investment and focus on direct comparative research helps to facilitate more informed discussions between clinicians and their patients about treatment options.” The following research presentations outlined the key findings from the studies: In the largest head-to-head randomized controlled trial (RCT) study (IMPACT), early patient outcomes were studied among UroLift™ PUL and Tamsulosin medication subjects.1 Preliminary data suggest that PUL with the UroLift™ system offers better symptom relief, quality of life improvements and patient satisfaction compared with alpha blockers within three months following the initiation of treatment.1 These findings could help to advance evidence-based shared decision making.1 First head-to-head RCT study comparing UroLift™ System experience against Rezūm (CLEAR) showcases a superior early patient experience* with the UroLift™ System (PUL) compared with water vapor thermal therapy (WVTT).2 Patients undergoing PUL with the UroLift™ System experienced more rapid symptom relief and quality of life improvements within the first three months post-treatment.2 Outcomes can aid healthcare providers and patients in gaining a clearer understanding of the perioperative experience, facilitating informed decisions regarding treatment options.2 A comprehensive analysis of post-surgery medication usage over five years among patients treated with the UroLift™ System, transurethral resection of the prostate (TURP), and GreenLight™ photoselective vaporization of the prostate (PVP).3 Post-surgery medication usage is an important and relatively unexplored facet of the BPH patient journey.3 The analysis found that medication use was similar among the three procedures through five years.3 This may indicate that in a real-world setting, contrary to expectations, not all TURP and PVP patients fully respond to the benefits of the intervention.3 Additionally, the medication rate following PUL with the UroLift™ System was consistent with what was observed in the L.I.F.T. pivotal study, further validating the integrity of the trial.3 A real-world analysis of hospitalizations and emergency department visits following surgical treatments for BPH showed patients treated with UroLift™ PUL had the lowest unplanned visits.4 Real-world evidence serves as a litmus test for how minimally invasive and surgical therapies for BPH perform outside the highly managed settings of a clinical trial.4These events are often not reported in controlled trials but should be considered when evaluating BPH treatment options.4 A review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device reports (MDRs) showed UroLift™ PUL had the lowest rates of mild, moderate, and severe complications year over year.***5 Once procedure volume is factored in, the UroLift™ System has the lowest rates of mild, moderate, and severe postoperative complications on a per case basis from 2019 to 2022 in the MAUDE database.***5The yearly rates of mild, moderate and severe events are significantly higher for invasive procedures like Aquablation® than the minimally invasive surgical therapies analyzed.5 “The AUA guidelines acknowledge there are patients with LUTS secondary to BPH who do not respond favorably to medicine and recommend reevaluations within a reasonable period after the initiation of treatment. The goal is for the provider and patient to decide whether to continue, stop, or switch to another therapy based on the symptomatic response of medication. In this context, IMPACT is of interest as it allows us to observe the patient journey after treatment with the UroLift™ System versus medication with the option for a cross-over after reassessment,” said Claus Roehrborn, MD, professor of urology at UT Southwestern Medical Center and primary investigator on the study.† “Initial results help us to understand not only efficacy comparisons, but also distinctions in patient satisfaction and goal attainment, where UroLift™ has an advantage. I commend Teleflex for facilitating a groundbreaking trial that will serve urologists and patients for years to come.” In addition to the presentation of clinical data, Teleflex showcased the new UroLift™ 2 System with Advanced Tissue Control (ATC), which has recently received FDA clearance. The UroLift™ 2 ATC System offers physicians enhanced confidence, improved control of obstructive tissue, and targeting accuracy through tissue control wings and laser-etched needle markers designed to make tissue manipulation and implant delivery more precise.6 A streamlined delivery system, typically utilizing one handle per procedure and individual implant cartridges, ensures increased physician comfort and improves efficiency during the procedure.6 BPH is a common condition in which the prostate enlarges as men get older. As the prostate enlarges, it can press on and block the urethra, causing bothersome urinary symptoms.7-8 The UroLift™ System is a minimally invasive treatment option for BPH that can help men get off BPH medications and avoid major surgery, while preserving sexual function.**9 It is the only leading enlarged prostate procedure that does not require heating, cutting, or destruction of prostate tissue.10-11 For more information about the UroLift™ System, visit www.UroLift.com. About the UroLift™ SystemThe UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ permanent implants, which can be delivered during an outpatient procedure,12 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.13 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**11,14 The 5-year L.I.F.T. study results demonstrate UroLift™ System durability with a surgical retreatment rate of about 2-3% per year and 13.6% total over 5 years.9 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.10 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2023 American Urological Association and 2024 European Association of Urology clinical guidelines. More than 475,000 men have been treated with the UroLift™ System in select markets worldwide.15 Learn more at www.UroLift.com. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. References:* Symptom relief and quality of life improvement following treatment **No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study *** While the MAUDE Database is a powerful resource, it is subject to certain limitations. These include the potential for underreporting of adverse events and the variability in the quality and consistency of the information reported. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions. †Claus Roehrborn is a paid consultant of Teleflex. Roehrborn, et al, AUA 2024. Preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS. AUA Study sponsored by Teleflex Incorporated or its affiliatesRoehrborn, et al, AUA 2024. The Early Patient Experience Following Treatment With PUL and WVTT, Two Contemporary MISTs for BPH: Preliminary Results From the CLEAR Study. AUA Study sponsored by Teleflex Incorporated or its affiliatesKaplan, et al, AUA 2024. A US Healthcare Claims Analysis Reveals Post-surgery Medication Use Through 5 Years Is Similar Between PUL, TURP, and GreenLight. AUA Study sponsored by Teleflex Incorporated or its affiliatesKaplan, Prostate Cancer Prostatic Dis 2023Shinghal R, Ashley M, Eure G, AUA 2024. Total Procedural Context is Crucial in Understanding BPH Treatment Device Safety in the FDA’s MAUDE Database. (Manuscript in preparation)Data on fileRosenberg, Int J Clin Pract 2007Vuichoud, Can J Urol 2015Roehrborn, Can J Urol 2017Roehrborn, J Urol 2013AUA BPH Guidelines 2003, 2020Shore, Can J Urol 2014Rukstalis, Prostate Cancer and Prostatic Dis 2018McVary, Urology 2019Management estimate based on product sales as of January 2024. Data on file Teleflex Interventional Urology. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck, list all Teleflex-owned trademarks in alphabetical order] are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2024 Teleflex Incorporated. All rights reserved. Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com 646-871-8485

长期以来，处方药的线上销售政策一直处于频繁更新状态。2022年9月，国家市场监督管理总局发布了《药品网络销售监督管理办法》，从政策层面加强了处方药网络销售的监管，也“官宣”了处方药线上销售的合法合规性。随着该政策的出台，药品生产企业开始积极探索与医药电商平台的合作，推动了处方药在各平台的广泛布局与市场增长。本文对国内主流医药电商平台（京东、天猫、淘宝）的处方药销售数据进行了宏观分析和品类分析，并对热门领域的头部品种和头部企业进行了特征描述。01医药电商处方药市场持续扩容自2022年《药品网络销售监督管理办法》发布以来，主流医药电商平台的处方药销售额大幅增长，2022年的增长率高达36%，比同年城市实体药店处方药的销售额增长率（9.6%）高出26个百分点（见图1）。图1：2021-2023年主流医药电商平台（京东、天猫、淘宝）处方药销售额及增长率来源：RPDB中国零售药店数据库，中国医药工业信息中心从产品数来看（见图2），2022年有销售记录的处方药产品数达到近3年的顶峰（6701个），随后的2023年产品数有所下降，但仍高于2021年。2022年有销售记录而2023年停售的产品，大部分是注射剂，停售有可能是线下渠道可及性提升、疫情平稳转段等因素综合作用的结果。图2：2021-2023年主流医药电商平台（京东、天猫、淘宝）处方药销售产品数统计来源：RPDB中国零售药店数据库，中国医药工业信息中心02各治疗类别处方药市场格局稳定，2023年司美格鲁肽表现亮眼从治疗类别来看（见图3），主流医药电商平台（京东、天猫、淘宝）2021年至今的处方药领域格局比较稳定，中药、泌尿系统用药、抗感染药、心血管系统用药和内分泌代谢调节用药的市场规模一直位列前5，中药和泌尿系统用药的排名一直在第1和第2的位置。图3：2021-2023年主流医药电商平台（京东、天猫、淘宝）各治疗类别处方药销售额占比来源：RPDB中国零售药店数据库，中国医药工业信息中心从产品来看（见图4），近3年销售额Top 10产品有部分变动。富马酸丙酚替诺福韦片和瑞舒伐他汀钙片是2022年进入Top 10列表中的产品，司美格鲁肽注射液、磷酸奥司他韦胶囊和磷酸奥司他韦颗粒是2023年进入Top 10列表中的产品。其中，司美格鲁肽注射液2023年的销售额增幅高达290%，媒体舆论对其减肥功效的宣传一定程度上成就了其高增长。图4：2021-2023年主流医药电商平台（京东、天猫、淘宝）销售额Top 10产品来源：RPDB中国零售药店数据库，中国医药工业信息中心03处方中成药：电商平台与实体药店销售额Top10产品大不相同图5展示了电商平台及实体药店的销售额Top 10处方中成药。安宫牛黄丸、小柴胡颗粒及小儿豉翘清热颗粒3个产品均在主流医药电商平台（京东、天猫、淘宝）及城市实体药店渠道的销售额Top 10产品中，而其他产品则大不相同。城市实体药店渠道的Top 10产品中，多为心血管用药（复方丹参滴丸、丹参片、速效救心丸、银杏叶片），这与该类产品的患者特征有关。心血管用药的使用者多为中老年群体，习惯在线下渠道购买药品。而电商平台的Top 10产品多为扶正剂（肾宝片、龟龄集、金匮肾气丸、右归丸），这与该类产品的服药特征有关。扶正剂主要用于增补人体正气，也就是大家常说的“补药”，大多服药周期长，在网上购买较为方便。图5：2023年主流医药电商平台（京东、天猫、淘宝）及城市实体药店销售额Top 10处方中成药来源：RPDB中国零售药店数据库，中国医药工业信息中心04泌尿系统处方药：电商平台与实体药店销售额Top10产品大不相同图6展示了电商平台及实体药店的销售额Top 10泌尿系统处方药。西地那非片、他达拉非片、达泊西汀片、非那雄胺片及坦索罗辛缓释胶囊5个产品均在主流医药电商平台（京东、天猫、淘宝）及城市实体药店渠道的销售额Top 10产品中，而其他产品则大不相同。城市实体药店渠道的Top 10产品中，多为前列腺增生用药和高磷酸盐血症用药（坦洛新缓释片、司维拉姆片、碳酸镧咀嚼片、爱普列特片、特拉唑嗪片），这些产品的服用均需要专业的指导和疾病管理，线下渠道更为合适。而电商平台的Top 10产品多为勃起功能障碍用药（爱地那非片、阿伐那非片、伐地那非片、西地那非口崩片），这与该渠道较强的隐私性有关。图6：2023年主流医药电商平台（京东、天猫、淘宝）及城市实体药店销售额Top 10泌尿系统处方药来源：RPDB中国零售药店数据库，中国医药工业信息中心05电商平台处方药销售额Top10企业中，跨国企业较多图7展示了电商平台及实体药店的处方药销售额Top 10企业，阿斯利康、诺华、辉瑞、东阳光4家企业均在列表中。电商平台的Top 10企业中，6家为跨国药企（辉瑞、诺和诺德、阿斯利康、吉利德、诺华、欧加隆），而城市实体药店渠道的Top10企业中，6家为内资药企（石药欧意、正大天晴、济川、东阳光、豪森、恒瑞）。在政策利好处方药线上销售的大环境下，内资药企可以进一步尝试布局线上渠道，开拓新的市场。图7：2023年主流医药电商平台（京东、天猫、淘宝）及城市实体药店处方药销售额Top 10企业来源：RPDB中国零售药店数据库，中国医药工业信息中心综上所述，医药电商将成为处方药市场推广的高潜力新渠道。由于产品特征及患者特征的不同，线上线下渠道的产品布局也会存在一定差异，通过RPDB中国药品零售数据库的实时监测，助您探索不同零售渠道的特征，做出差异化的布局决策。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001