Tolterodine Tartrate

CASTRES, France , April 26, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of OBGEMSA™ (vibegron under the international non-proprietary name) for the symptomatic treatment of adult patients with overactive bladder syndrome (OAB). Pierre Fabre Laboratories acquired an exclusive license from Urovant Sciences to register and commercialize vibegron in the European Economic Area in 2022. OBGEMSA™ is a trademark owned by Urovant Sciences GmbH. The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for OBGEMSA™ (vibegron). The decision will then be applicable to all member states of the European Union as well as to Iceland, Liechtenstein and Norway. " We are very pleased to have received this positive opinion from the CHMP for OBGEMSA ™. If approved, this innovative therapeutic solution has the potential to help patients suffering from overactive bladder, a condition that is very debilitating in daily life. We have been working in the field of urology for more than 40 years and OBGEMSA is proof of our determination to continue our development in this area." said Eric DUCOURNAU, CEO of Pierre Fabre Laboratories. The CHMP positive opinion is based on positive data from two Phase 3 pivotal, randomized, multicenter and double-blind studies in patients with symptoms of overactive bladder. Study RVT-901-3003 assessed the efficacy, tolerability and safety at 12 weeks of vibegron (at a dose of 75 mg/daily) compared to placebo and tolterodine (as positive control). Its extension, Study RVT-901-3004, assessed the long-term safety, tolerability and efficacy of vibegron at 52 weeks versus tolterodine. In these studies, vibegron, as a new beta-3 adrenergic receptor (ß3 AR) agonist, demonstrated a favourable risk-benefit profile in the symptomatic treatment of urgency, increased micturition and urge urinary incontinence (UUI) that may occur in patients with OAB syndrome. The CHMP positive opinion is also supported by clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of vibegron (at a dose of 75 mg daily or placebo once daily) for a duration of 28 days at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that vibegron 75 mg had no statistically significant or clinically meaningful effects on Blood Pressure or Heart Rate in patients with symptoms of OAB. About overactive bladder (OAB) The OAB syndrome is clinically characterized by urinary urgency (i.e. a sudden compelling desire to void that is difficult to defer), with or without urge urinary incontinence UUI, and usually accompanied by urinary frequency and nocturia in the absence of urinary tract infection or other obvious pathology. UUI is the involuntary loss of urine accompanied by urgency. UUI is distinguished from stress urinary incontinence, which is the involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing. When both components are present, the classification is mixed urinary incontinence, with either urgency or stress specified as the predominant component. From a pathophysiological perspective, the OAB symptom complex is suggestive of detrusor overactivity, which may be intrinsic or may be secondary to neurological conditions such as stroke or spinal cord injury. About vibegron Vibegron is a novel, potent, and selective human beta-3 adrenergic receptor (β3-AR) agonist. Beta receptors are found throughout the body, but β3-ARs are predominantly found on human detrusor smooth muscle. β3-ARs agonists bind to and activate beta-3 receptors on the detrusor muscle, leading to relaxation of the detrusor muscle to increase vesical capacity and to reduce OAB symptoms. Vibegron received approval in the U.S. in December 2020 (at 75 mg once daily, under the tradename GEMTESA®) for the treatment of OAB with symptoms of UUI, urgency, and urinary frequency in adults and in Japan and in the Republic of Korea, respectively in September 2018 and in October 2022 (at 50 mg once daily, under the tradename BEOVA®) for the treatment of OAB in adults. GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries. In the U.S., GEMTESA is marketed by Sumitomo Pharma America, Inc. About Pierre Fabre Laboratories For more information, visit , @PierreFabreGroup. PRESS CONTACT : PIERRE FABRE Anne Kerveillant, [email protected] Logo - SOURCE Pierre Fabre

精彩内容近日，人福医药发布了2023年业绩，公司的营业收入首次突破240亿元，研发投入超过15亿元，双双创出新高。作为神经系统药物龙头企业，人福医药2023年该类药物大卖超85亿，五大产品市场份额飞升，成绩亮眼。近几年公司创新转型不断提速，2024年一季度公司拿下了首款按古代经典名方目录管理的中药复方制剂芍药甘草颗粒，目前有20款新药加速推进临床，36个仿制药新品冲刺上市。营业收入首破240亿，研发投入再涨36%人福医药2023年的营业收入达245.25亿元，为公司上市以来的新高，净利润达21.34亿元。被誉为“麻醉一哥”的人福医药，公司的麻醉药产品营收继续保持快速增长，2023年实现销售收入约67亿元，同比增长约16%，其中非手术科室增速亮眼，实现销售收入约20.3亿元，同比增长约39%。公司表示，面对新的发展机遇和挑战，坚持“做医药细分市场领导者”的发展战略，通过“聚焦、创新、国际化”三大战略路径，持续巩固和提升核心竞争力，不断增强可持续发展能力。预计2024年公司的营业收入可达到260亿元以上，产品综合毛利率在45%以上。图1：人福医药的研发投入情况（单位：亿元）来源：公司年报目前人福医药已在神经系统用药、甾体激素类药物、维吾尔民族药等细分领域形成领导地位，同时有序开展创新药、仿制药的研发，不断丰富管线储备尽显长期增长活力。据公司年报数据显示，2021年人福医药的研发投入合计突破10亿元，2023年高达15.41亿元，增长率为35.92%，是近五年增速最高的一年。不吝啬的付出一定会迎来大丰收，近几年公司不断有新品获批上市，公司的市场竞争力得到了快速提升。神经系统用药大卖超85亿，5大产品份额飞升图2：人福医药的神经系统用药营收情况（单位：亿元）来源：公司年报神经系统用药是人福医药的拳头领域，从公司近五年的年报数据来看，公司该类药物的营业收入保持着高速增长态势，近五年均有双位数增长，2023年创出新高达到85.29亿元。米内网数据显示，2023年在重点省市公立医院终端，宜昌人福药业已成为了神经系统药物市场TOP1企业，是市场份额唯一超过10%的企业。表1：2023年宜昌人福药业的神经系统药物在各亚类市场的情况来源：米内网重点省市公立医院药品终端竞争格局目前，人福医药有6款畅销产品在神经系统药物三个亚类市场名列前茅。公司的注射用盐酸瑞芬太尼稳坐麻醉剂TOP1品牌宝座，2023年市场份额上涨了1.73%；盐酸阿芬太尼注射液品牌排名上升了3位，市场份额也有所上涨。公司的盐酸氢吗啡酮注射液和盐酸纳布啡注射液稳守止痛药TOP5、TOP6品牌，2023年市场份额分别上涨了1.59%和0.64%。公司的1类新药注射用苯磺酸瑞马唑仑排名上升了4位，为精神安定药TOP14品牌，市场份额上涨了0.63%。拓展新适应症有利扩大产品的使用范围，更大地满足临床需求，助力公司进一步提升市场竞争力。2023年11月，人福医药的盐酸纳布啡注射液新适应症“术后镇痛”获批上市；2024年2月，公司的注射用盐酸瑞芬太尼新适应症“重症监护患者机械通气时的镇痛”获批上市；2024年3月，公司的1类新药注射用磷丙泊酚二钠新适应症“用于成人重症监护患者的镇静”以及“用于成人全身麻醉的诱导和维持”获批临床。2024年开局大丰收！20个新药、36个仿制药加速冲刺米内网数据显示，2023年人福医药获批上市的新产品有15个（不含新增适应症），均为化学药，涉及8个大类（12个亚类），公司的拳头大类神经系统药物占了4个。盐酸氢吗啡酮缓释片为国内首仿，枸橼酸托法替布缓释片为公司首款免疫抑制剂，注射用米卡芬净钠为公司首款全身用抗真菌药，非布司他片为公司首款抗痛风制剂。表2：2024年至今人福医药获批的新产品（按批文日期统计）来源：米内网中国申报进度（MED）数据库2024年一季度人福医药收获满满，公司首款按古代经典名方目录管理的中药复方制剂获批，人福医药成为了芍药甘草颗粒首家获批企业。此外，恩扎卢胺软胶囊成为公司首款上市的内分泌治疗用药，为公司成功开拓了新市场。表3：2021年至今人福医药及子公司报产在审的产品来源：米内网中国申报进度（MED）数据库2021年至今人福医药及子公司申报上市并在审评审批中的产品有36个，涉及10个大类（21个亚类），拳头大类神经系统药物（6个亚类）占了10个产品。目前国内市场上市暂无布洛氢可酮片、酒石酸托特罗定缓释胶囊、奥卡西平口服混悬液、利斯的明透皮贴剂、盐酸他喷他多片、萘普生钠软胶囊、屈螺酮炔雌醇片的国产仿制药获批，人福医药将参与这7个产品的国内首仿争夺。此外，人福医药目前暂无止吐药和止恶心药上市，若公司的注射用福沙匹坦双葡甲胺顺利获批，将成为公司在该亚类市场的首款药物，值得期待。表4：人福医药部分在I期以上临床阶段的重磅新药（不含新增适应症）注：部分终止临床的新药暂不纳入统计来源：公司年报、米内网中国临床试验数据库人福医药近几年不断加码新药研发，化学药、生物药、中成药均有布局，目前有20款新药正在积极推进临床研究，其中2款已在III期临床阶段，离报产仅一步之遥。氨酚氢可酮缓释片为改良新药，在今年3月启动了治疗中重度疼痛的III期临床。此外，中药1.1类新药复方薏薢颗粒在今年2月启动了痛风非急性期高尿酸血症（湿浊瘀阻证）的II期临床，改良新药HZ-J001乳膏也在今年3月启动了特应性皮炎的I期临床试验。制剂出海大卖超20亿，ANDA文号达220多个人福医药坚持实施国际化战略，整合集团国际化资源，形成全球研发、注册、生产、销售的医药全价值链能力，呈现出“走出去、引进来”协同发展、国际市场与国内市场双循环的发展格局。公司面向全球医药市场进行产业布局，海外业务现已覆盖了欧美成熟市场以及南美、东南亚、中亚、西非、东非等新兴市场，公司国际化体系已形成并初具规模。表5：人福医药2023年至今获批的ANDA文号（含暂定批准）来源：公司公告据公司公告统计，2023年人福医药新获得的ANDA文号有5个。截至目前，人福医药各子公司已累计获得220多个FDA批准的ANDA文号，稳守制剂出海第一梯队。据年报数据显示，人福医药的美国仿制药业务2023年实现销售收入约20.30亿元，较上年同期增长约14%。资料来源：米内网数据库、公司年报等注：米内网重点省市公立医院化学药终端竞争格局数据库是以20+省市，近700家样本省市公立医院的化学药采购数据为基础，对化学药全品类进行连续监测的样本省市样本医院数据库；上述销售额以产品在终端的平均零售价计算。数据统计截至4月3日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦