Theravance, Inc. /Biopharm Ops/

Former William Blair partner and group head, Lugo has facilitated raising more than $6 billion in capital through 40-plus transactions, including IPOs Veteran venture capitalists Drs. Seidenberg and Tananbaum will help scale and accelerate the development of Latigo's pipeline of non-opioid pain medicines THOUSAND OAKS, Calif., Sept. 9, 2024 /PRNewswire/ -- Latigo Biotherapeutics Inc. ("Latigo"), a clinical-stage biotechnology company developing best-in-class non-opioid pain medicines that target pain at its source, today announced the appointment of Tim Lugo as chief financial officer (CFO). In addition, Latigo has appointed Beth Seidenberg, M.D., and Jim Tananbaum, M.D., to its board of directors. These appointments bring deep expertise and leadership as Latigo scales to rapidly advance its lead clinical programs. Continue Reading Tim Lugo, CFO, Latigo Biotherapeutics "Tim's extensive experience in biotechnology finance and equity research and business development will be invaluable as we continue to scale the company and advance our pipeline," said Nima Farzan, chief executive officer of Latigo Biotherapeutics. "With the addition of venture capital veterans Drs. Seidenberg and Tananbaum to our board, Latigo is well-positioned to achieve our mission of providing effective, non-addictive pain relief to millions of patients in need." "I am excited to join Latigo at such a pivotal time," said Lugo. "Our goal is to ensure that our innovative pipeline of non-opioid pain medications reaches the patients who need them as quickly as possible. I look forward to applying my experience in biotech finance, financial markets, and business development to help Latigo become a global leader in non-opioid pain management." "We have a once-in-a-generation opportunity to develop medicines that can dramatically improve patient outcomes while simultaneously helping solve the devastating societal problem of opioid addiction," said Dr. Seidenberg, founding managing director of Westlake Village BioPartners. "I am honored to join Latigo's board and work with such an innovative team. The company's focus on addressing one of the most critical public health issues of our time – opioid addiction – through non-opioid pain medicines is truly transformative." "Latigo's approach to pain management is both innovative and essential in today's healthcare landscape," said Dr. Tananbaum, founder and chief executive officer of Foresite Capital. "I look forward to working alongside my fellow board members and Latigo's world-class leadership team to help drive the company's growth and success and fulfill its mission of relieving pain and restoring health." About Tim Lugo Tim Lugo brings two decades of experience as a financial analyst covering the biotechnology and pharmaceutical sectors to Latigo as its first chief financial officer. Most recently, he was a partner and group head of biotechnology equity research at William Blair, where he focused on covering small and mid-sized biotechnology companies. Under his leadership, the team grew to cover more than 100 companies and was consistently named a Top 5 research team in the small and mid-sized biotechnology sector by Greenwich Associates LLC. Lugo has also been recognized as a top stock picker and earnings estimator by Thomson Reuters during his tenure as an analyst. His expertise in the sector facilitated the raising of more than $6 billion in capital through 40-plus transactions, including initial public offerings (IPOs) and other significant deals for both private and public companies. Before joining William Blair, he worked at Pacific Growth Equities as a junior analyst, served as a healthcare consultant focused on reimbursement and pricing of new therapies, and engaged in business development at a genomics startup. In addition to his work in the biotechnology sector, Lugo sits on the board of trustees at Children's Day School in San Francisco. He holds a B.A. in molecular and cellular biology (with an emphasis in genetics) and a B.A. in economics, both from the University of California, Berkeley. About Beth Seidenberg, M.D. Beth Seidenberg, M.D., is the founding managing director of Westlake Village BioPartners. She was a general partner at Kleiner Perkins and has incubated and invested in more than 40 biotech companies across many therapeutic areas and modalities since 2005. She currently sits on the public company boards of Vera Therapeutics, Progyny, Kyverna Therapeutics, Sagimet Biosciences, and Acelyrin. Previously, Seidenberg served in leadership roles at Bristol-Myers Squibb, Merck Research Laboratories and Amgen, where she was chief medical officer and head of global development. In these roles, she developed new treatments for AIDS, arthritis, asthma, cancer, psoriasis, cardiovascular, metabolic, neurological, and renal disorders for more than 20 years, introducing 10 innovative products to market. Seidenberg received her M.D. from the University of Miami School of Medicine, completed her medical residency at Johns Hopkins University and George Washington University, and her fellowship at the National Institutes of Health. She received a B.A. in biology and anthropology from Barnard College. About Jim Tananbaum, M.D. Jim Tananbaum, M.D., is the founder and chief executive officer of Foresite Capital, a U.S.-focused healthcare investment firm with approximately $3.5 billion in assets under management. Tananbaum has been a thought partner for impactful and fast-growing companies, including 10x Genomics, Amerigroup, and Jazz Pharmaceuticals. Tananbaum's career in healthcare investment spans more than three decades. He has founded and led multiple successful companies, including GelTex Pharmaceuticals, which brought two drugs to market and was acquired for $1.4 billion, and Theravance Inc., which has a market capitalization exceeding $4 billion. Tananbaum holds an M.D. from Harvard University, an M.B.A. from Harvard while playing rugby, and a B.S. and B.S.E.E. in applied math and electrical engineering/computer science from Yale University. About Acute and Chronic Pain Acute pain typically arises from post-operative surgical procedures or non-surgical injuries. The primary treatments include NSAIDs and opioids, with approximately 40 million opioid prescriptions written each year for acute pain management. Opioids carry a significant risk of long-term dependency, with 19% of patients exposed to opioids potentially developing dependency. Four million Americans each year transition to chronic opioid use after initially being prescribed opioids for low-risk surgeries. Chronic pain affects approximately 57 million people in the U.S. as a result of conditions such as diabetic neuropathy, osteoarthritis, migraine, and lower back pain. The current standard of care involves opioids and gabapentinoids contributing to 150 million prescriptions annually, of which half are opioids. Chronic pain patients often suffer from inadequate pain relief and experience debilitating side effects from existing therapies, including dizziness and somnolence. Moreover, 80% of individuals using illicit opioids or heroin initially started with prescription opioids, underscoring the critical need for safer, more effective pain management strategies. About Latigo Biotherapeutics Latigo Biotherapeutics is a private clinical-stage biotechnology company developing innovative non-opioid pain medicines with potential best-in-class profiles that directly target the source of pain. Latigo's goal is to provide effective, rapid-acting pain relief without the risk of addiction. Latigo is supported by leading investors, including Westlake Village BioPartners, 5AM Ventures, Foresite Capital, and Corner Ventures. For more information, please visit or follow us on LinkedIn. SOURCE Latigo Biotherapeutics

「  本文共：16条资讯，阅读时长约：3分钟 」今日头条祐儿医药多动症改良型新药获批上市。祐儿医药与Tris Pharma公司开发的盐酸哌甲酯口服缓释干混悬剂获国家药监局批准上市，用于治疗注意缺陷多动障碍（ADHD，俗称多动症）。这是一款中枢神经系统（CNS）兴奋剂，此前NMPA已批准盐酸哌甲酯缓释咀嚼片上市。在临床研究中，混悬剂和咀嚼片均可以在45分钟至12小时内显著改善患者多动症症状。国内药讯1.三生制药米诺地尔泡沫剂获批上市。三生制药5%米诺地尔泡沫剂（蔓迪）获国家药监局批准上市，用于治疗男性脱发和斑秃。这是一款非处方用药，其处方体系不含有丙二醇（少数患者敏感），可以减少过敏瘙痒的发生率；同时，泡沫剂给药更精准，可以避免对非预期部位刺激毛发生长；易于患者脱发部位的有效定位治疗，给患者带来更好的顺应性和体验感。2.恒瑞两款创新药获批上市。恒瑞医药两款创新药盐酸伊立替康脂质体注射液和恒格列净二甲双胍缓释片同日获国家药监局批准上市。盐酸伊立替康脂质体适用于联合5-FU/LV二线治疗经吉西他滨治疗失败后局部晚期或转移性胰腺癌患者；恒格列净二甲双胍缓释片用于适合接受脯氨酸恒格列净和盐酸二甲双胍治疗的2型糖尿病成人患者，以改善其血糖控制。3.药明巨诺CD19靶向CAR-T新适应症报产。药明巨诺靶向CD19的CAR-T产品瑞基奥仑赛注射液（商品名：倍诺达）的新适应症上市许可申请（sBLA)获国家药监局受理，用于治疗复发或难治套细胞淋巴瘤（r/r MCL）患者。在Ⅱ期临床中，瑞基奥仑赛治疗达到81.8%的客观缓解率。此前，CDE已将该产品用于治疗r/r MCL的适应症纳入突破性治疗品种，以及纳入优先审评。4.康方PD-1/CTLA-4双抗新适应症报产。康方生物PD-1/CTLA-4双抗卡度尼利单抗（开坦尼）注射液新适应症上市申请获CDE受理，推测申报的适应症为“一线治疗不可手术切除的局部晚期或转移性胃腺癌或胃食管结合部腺癌（GC/GEJC）”。在III期临床（AK104-302）中，与安慰剂联合化疗相比，AK104联合化疗显著延长患者总生存期（OS）；安全性数据与既往研究一致。详细结果将在国际学术会议上公布。5.信瑞诺医药被诺华收购。诺华宣布收购信瑞诺医药，并获得该公司2个针对免疫球蛋白A肾病(IgAN)创新药项目atrasentan和zigakibart。Atrasentan是一款口服选择性内皮素受体(ETA)拮抗剂，正在进行IgAN的III期临床开发；Zigakibart(BION-1301)是一款皮下给药的APRIL单抗，已在2023年10月启动III期临床研究。信瑞诺拥有atrasentan和zigakibart在中国和新加坡的独家权益。国际药讯1.FIC抗病毒凝胶获FDA批准上市。Ligand公司局部抗病毒凝胶Zelsuvmi（berdazimer，10.3%）获FDA批准上市，成为首款获批用于成人和一岁及以上儿童传染性软疣患者的“first-in-class”药物。在关键Ⅲ期临床B-SIMPLE4中，SB206治疗12周后患者实现病灶完全清除的患者比例更高，具统计学意义的显著改善（p值<0.001），药物耐受性良好。这是2024年FDA批准的首个上市许可。2.辉瑞血友病基因疗法获批加拿大上市。辉瑞基因疗法Beqvez（fidanacogene elaparvovec）获加拿大卫生部批准上市，这是Beqvez的全球首个上市许可，用于治疗≥18岁、中重度至重度血友病B成人患者。在Ⅲ期临床（BENEGENE-2）中，与FIX预防性治疗方案相比，Beqvez单次给药达到主要研究终点，所有患者的年平均出血率（ABR）从预处理期的4.43降至1.3（降低71%，p<0.0001）；年化输注率也降低92%（p<0.0001）。3.Theravance公司COPD药物IV期临床失败。Theravance公司长效雾化支气管扩张剂Yupelri（revfenacin）用于治疗慢性阻塞性肺病（COPD）维持治疗的IV期PIFR-2研究未达主要终点。与噻托溴铵（Spiriva，粉雾剂）对照组相比，revfenacin治疗第85天时患者第一秒用力呼气谷值较基线变化的统计未达到统计学意义的显著改善。Yupelri的安全性与耐受性与既往研究一致。4.艾伯维超14亿美元布局体内CAR-T。艾伯维与Umoja Biopharma将利用后者专有的VivoVec平台，针对艾伯维所选择的靶标，合作开发多个原位生成CAR-T细胞疗法候选物。艾伯维还将拥有Umoja公司临床前期、拟用于治疗血液恶性肿瘤的CD19靶向原位生成CAR-T疗法UB-VV111的独家选择权。根据协议，Umoja将获得前期付款，总计高达14.4亿美元的选择权行使、开发和监管里程碑款项。5.BI购进一款纤维炎症性新药。勃林格殷格翰宣布与Kyowa Kirin达成合作许可协议，获得后者开发的一款新型、潜在“first-in-class"治疗纤维炎症性疾病疗法的全球独家权利。根据协议，Kyowa Kirin将获得预付款，开发、监管和商业里程碑后期付款，交易金额总计达到4.1亿欧元。勃林格殷格翰专注开发纤维炎症性疾病的相关疗法，其研发管线中PDE4b抑制剂BI 1015550目前正在两项III期临床中用于治疗特发性肺纤维化（IPF）和进展性肺纤维化。6.Allorion公司两款新药授权给Avenzo公司。Avenzo Therapeutics宣布与Allorion公司达成合作许可协议，获得后者临床早期细胞周期蛋白依赖性激酶2（CDK2）选择性抑制剂ARTS-021（AVZO-021）大中华区以外的全球开发和商业化权益，以及一个临床前期项目的独家选择权。根据协议，Allorion将获得4000万美元的首付款，开发、监管和销售里程碑后期款项，以及产品的销售分成，两个项目的总交易金额将超过10亿美元。医药热点1.首都医科大附属北京地坛医院徐州医院揭牌。1月6日，第五批国家区域医疗中心建设项目首都医科大学附属北京地坛医院徐州医院暨徐州市第七人民医院正式揭牌，全面启动项目建设。目前，第一批地坛医院专家已入驻徐州市第七人民医院。下一步，项目医院将实行“双主任制”制度，全面引进北京地坛医院优势专科、学科、技术、人才管理等资源，打造以肝病、艾滋病、感染性疾病等专科为主、综合科室协同发展的全国一流国家区域医疗中心。2.瑞金医院紧急医学救治中心项目获批。为提升上海市综合应急医疗救援能力，上海交通大学医学院附属瑞金医院紧急医学救治中心项目已获可行性研究报告批复。瑞金医院紧急医学救治中心项目选址位于黄浦区瑞金二路197号上海交通大学医学院附属瑞金医院院内，新建总建筑面积73500平方米，设置医疗床位600张。3.教育部：高校「新」增设2个药学专业。近日，教育部印发《服务健康事业和健康产业人才培养引导性专业指南》。《专业指南》提到，为对接国家重大需求，服务健康事业和健康产业发展新态势，设置医疗器械与装备工程、老年医学与健康、健康与医疗保障、药物经济与管理，生物医药数据科学5个新医科人才培养引导性专业。其中2个药学专业，药物经济与管理、生物医药数据科学；生物医药数据科学专业授予理学学位，药物经济与管理专业授予管理学学位，各专业修业年限为四年。  评审动态  1. CDE新药受理情况（01月06日) 2. FDA新药获批情况（北美01月04日）股市资讯上个交易日 A 股医药板块 -1.94%涨幅前三     跌幅前三启迪药业+10.00%  凯因科技 -9.99%生 物 谷 +8.33%  无锡晶海 -6.78%万泰生物 +7.42%  金 迪 克 -6.64%【恒瑞医药】1、子公司山东盛迪医药有限公司收到恒格列净二甲双胍缓释片的《药品注册证书》，用于2型糖尿病成人患者的血糖控制。2、获得盐酸伊立替康脂质体注射液的《药品注册证书》，用于治疗经吉西他滨化疗失败的局部晚期或转移性胰腺癌患者。【华北制药】旗下子公司华北制药金坦生物技术股份有限公司获得人促红素注射液《药品补充申请批准通知书》，允许新增产品规格和适应症。【福瑞股份】2023年度预计实现归属于上市公司股东的净利润9,787.14万元至12,723.28万元，同比上年变动幅度为0%至30%；扣除非经常性损益后的净利润8,587.14万元至11,523.28万元，同比-14%至16%。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

1月5日，Theravance Biopharma宣布Yupelri（revfenacin）吸入溶液用于慢性阻塞性肺病（COPD）维持治疗的IV期PIFR-2研究未达主要终点。这项PIFR-2研究旨在评估，Yupelri较噻托溴铵（Spiriva，粉雾剂）在严重至极为严重COPD患者的肺功能改善情况。研究结果显示，第85天时第一秒用力呼气谷值较基线变化的主要终点指标方面，与对照组相比，Yupelri并未有统计学显著差异。Yupelri的安全性与耐受性与既往研究一致。Revfenacin吸入溶液是一款每日一次通过雾化吸入使用的长效毒蕈碱拮抗剂（LAMA），于2018年11月在美国获批用于COPD的维持治疗。据财报，Yupelri的2022全年收入达到0.707亿美元。本次研究的失败也导致Theravance股价下跌10%。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。