Carbidopa

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。来自德国🇩🇪史达德（STADA）集团，承载着严谨的德国药剂师基因的制药企业。公司始于1895年，一群远见卓识的药剂师携手在德累斯顿创立德国药剂师协会，这标志着史达德的诞生。该集团名字源自“Standardpr ParateDeutscher Apotheker”，即药剂师所制造的标准产品的代称。  STADA目前拥有11466名员工，其中7000+名技术研发人员，在1903年就首次制定了从药用原料、生产工艺到药品包装全过程的标准化生产法规。公司聚焦于仿制药、特药、消费者健康三大模块。史达德在2023年保持增长势头，销售额和利润均实现两位数增长。集团销售额增长14%，达37.3亿欧元。得益于通胀压力之下商品成本的改善以及稳定可靠的供应，调整后息税折旧及摊销前利润（EBITDA）增长19%，达8.02亿欧元。公司在2023财年做了95项许可交易（licensing deals）来促进业务纵深。2023年仿制药业务部门同比增加6%业绩，达15亿欧元。贡献业绩的产品有抗凝药物阿哌沙班、糖尿病药物西格列汀、止痛领域的他喷他多、用于移植患者的他克莫司，以及用于逆转肌肉松弛剂效果的舒更葡糖钠。新特药领域在2023年增长25%，增速为几大业务之最；目前为7.49亿欧元。产品包括多款生物类似药（biosimilar）（雷珠单抗、阿达木单抗、贝伐珠单抗、特立帕肽）。Uzpruvo（乌司奴单抗，Ustekinumab）的生物类似药即将上市，目前已经获批，等待欧洲市场原研药物专利过期。2023年上半年，史达德在药品可及性方面取得重大进展。美国食品药品监督管理局批准（FDA）从史达德位于德国尤特森的一家工厂向美国出口重组人红细胞生成素（EPO）。欧盟也几近同时确认位于越南绥和的新工厂符合要求严格的欧洲《药品生产质量管理规范》（GMP）标准，这为向欧洲出口提供了持续可靠的供应保障。与此同时，位于罗马尼亚图尔达供应链中心建设进展顺利；该中心投资超过5000万欧元，将大幅提升史达德在欧洲的供应链网络能力。在帕金森疾病（PD）领域，史达德的Lecigon pump成功结合三种经过验证的活性药物成分（levodopa + carbidopa + entacapone），用于治疗晚期帕金森病。该药品近期已在保加利亚、爱尔兰、西班牙和瑞士等更多国家上市，已有超千名患者使用；本品最早由LobSor Pharmaceuticals AB开发，相关专利WO-2016036308。药融云数据www.pharnexcloud.com；改良新药新复方在肾脏病学领域，欧盟批准的首个用于治疗罕见、慢性和致残性肾病IgA肾病的药物Kinpeygo（其他商品名Nefecon/Tarpeyo，4mg布地奈德靶向迟释胶囊）正在惠及更多患者。药融云数据www.pharnexcloud.com显示：Kinpeygo/Nefecon/Tarpeyo采用肠溶包衣，Nefecon/Tarpeyo这种改良新药的新剂型，可将布地奈德特异性递送至回肠的派尔集合淋巴结（负责产生分泌性免疫球蛋白A）处。胶囊溶解后，三层包衣微丸持续稳定释放布地奈德，高浓度覆盖整个靶区域。本品首创的瑞典公司Calliditas成立于2004年，产品最早购买权益于瑞典乌普萨拉大学（Uppsala University）两位教授那里。（中国等市场，云顶新耀持有相关权益，IgA肾病亟需新药：布地奈德改良新药美国加速获批）在2022年第4季度首次成为德国市场第一大OTC供应商。2020年从葛兰素史克（GSK）手中收购15个在欧销售的药品与保健品牌，2023年从赛诺菲收购多个欧洲国家的知名消费者健康品牌(Antistax、Lomudal、Omnivit和Opticrom滴眼液等)，构建多元化营养矩阵。1996年首度进入中国大陆。2021年，史达德在上海设立大中华区总部，显示出对中国大陆市场的高度重视。2024年5月28日，再来一单交易！来自中国的百奥泰生物制药股份有限公司（上交所代码：688177）与STADA Arzneimittel AG就BAT2506（一款参照欣普尼®戈利木单抗开发的生物类似药）签署授权许可及商业化协议，STADA将拥有BAT2506在欧盟、英国、瑞士以及其他部分欧洲国家市场的独占的商业化权益。根据协议条款，百奥泰将负责BAT2506的研发、生产以及商业化供应，STADA将负责BAT2506在欧盟、英国、瑞士以及其他部分欧洲国家市场的商业化。在达到相应的里程碑事件后，百奥泰可获得首付款加上里程碑款总金额最高至1.575亿美元，以及净销售额的两位数百分比作为收入分成。附，分享：此前3月底，公开了STADA集团年报。发送仿制药（请正确复制）至下方药融圈微信公众号后台可获得原文件。仅供学习交流分享！参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；https://www.stada.com/;2023年财报，https://www.stada.com/media/8669/fy2023-annual-report-stada.pdf；https://www.stadabeijing.com/；Pharmaceutical Executive, Pharma 50 Insight: The Accelerating Growth of Specialty Markets. Waseem Noor and Michael Kleinrock, 2022. https://www.pharmexec.com/；史达德2023年销售额和利润继续保持两位数增长，https://mp.weixin.qq.com/s/32m0q02jGSjblg7tk7f_Ow；www.bio-thera.com；本稿中不再涵盖其俄罗斯业务，该业务由史达德在其前俄罗斯子公司（AO Nizhpharm、OOO Aqualor、Dialogfarma LLC和OOO Hemofarm）中的股权组成，这些股权已于2023年9月转让给史达德集团之外的另一家公司；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐 活动推荐  8月 • NDC2024生物医药创新者峰会  关键词：  小分子，XDC，多肽及GLP-1热点话题，200+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

Full Dataset from Phase 2a trial in Parkinson’s Disease suggest patients treated with bezisterim experienced significant improvements in both non-motor symptoms and motor control while placebo-treated patients worsened Improvements in non-motor symptoms correlated with improvements in motor symptoms for Parkinson’s Disease patients May 22, 2024 -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced data from an oral presentation made yesterday at the XXIX World Congress on Parkinson’s Disease and Related Disorders hosted by the International Association of Parkinsonism and Related Disorders (IAPRD) and held May 19-22, 2024 in Lisbon, Portugal. The presentation Improvement of Motor and Non-Motor Symptoms with Bezisterim Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study was presented on May 21, 2024, and suggest improvements of bezisterim-treated patients with non-motor symptoms. These full dataset findings complement previously reported topline dataset findings of improvement in motor symptoms in patients treated with bezisterim and demonstrate potential intrinsic, levodopa-enhancing activity of bezisterim that is consistent with data from animal models. Patients treated with bezisterim and levodopa/carbidopa experienced a -2.8 point advantage on the Patr III (Motor) score on the Motor Disease Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) compared to patients treated with placebo and levodopa/carbidopa. In patients younger than 70 years old (~50% of patients), the advantage for bezisterim-treated patients was -4.7 points. Furthermore, 30% of bezisterim-treated patients experienced improvement in their ability to move, having Part 3 scores prior to their first morning dose of carbidopa/levodopa that were equal to or better than Part 3 scores associated with their being in the “on” state after carbidopa/levodopa treatment at the start of the study, whereas none of the placebo patients had the similarly improved morning Part 3 scores. The difference was statistically significant (p=0.02). Bezisterim-treated patients experienced a significant improvement of -2.4 points for the sleep/fatigue domain of the Non-Motor Symptom Scale (NMSS) in Parkinson’s Disease, whereas placebo patients experienced a worsening of +1.0 points (p=0.0159). Sleep/fatigue domain improvements correlated with motor score improvements (r=0.51; p=0.0259). More patients on bezisterim had improvements in the NMSS sleep/fatigue domain, while more patients on placebo worsened. Bezisterim-treated patients experienced an improvement of -0.89 on the urge to move legs/restlessness in legs whereas placebo patients experienced a worsening of +0.99 (p=0.0321). “These full dataset findings suggest that bezisterim as adjunct therapy to levodopa may hold promise in ameliorating specific non-motor symptoms of Parkinson’s Disease, particularly in sleep/fatigue and restlessness of the legs,” stated Joseph Palumbo, BioVie’s Chief Medical Officer. “These findings extend previously reported improvement in motor symptoms with bezisterim and demonstrate potential intrinsic and levodopa-enhancing activity of bezisterim that is consistent with data from animal models and support further clinical investigation of bezisterim in late-phase trials.” Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is being investigated for Alzheimer’s disease (AD) and Parkinson’s disease (PD). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S. Food and Drug Administration (“FDA”) Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. The content above comes from the network. if any infringement, please contact us to modify.