A PHASE 2, MULTI-CENTER, DOUBLE-BLIND, TWO-ARM STUDY OF SUBCUTANEOUS RVT-3101 FOR THE TREATMENT OF SUBJECTS WITH MODERATE TO SEVERE ACTIVE CROHN’S DISEASE - RVT-3101-201

开始日期2023-11-07

申办/合作机构

Telavant, Inc.

NCT05471492 / Withdrawn临床2期

A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity

开始日期2023-07-30

申办/合作机构

Telavant, Inc.

[+1]

NCT05107492 / Completed临床1期

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS

This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.

开始日期2021-11-19

申办/合作机构

Pfizer Inc.

100 项与 Afimkibart 相关的临床结果

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100 项与 Afimkibart 相关的转化医学

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100 项与 Afimkibart 相关的专利（医药）

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项与 Afimkibart 相关的文献（医药）

2022-03-02·Inflammatory bowel diseases2区 · 医学

Antitumor Necrosis Factor-like Ligand 1A Therapy Targets Tissue Inflammation and Fibrosis Pathways and Reduces Gut Pathobionts in Ulcerative Colitis

2区 · 医学

Article

作者: Ye, Zhan ; Zhang, Jenny ; Danese, Silvio ; Li, Xingpeng ; Hassan-Zahraee, Mina ; Chandra, Deepa E ; Hung, Kenneth E ; Quan, Jie ; Neelakantan, Srividya ; Hyde, Craig L ; Klopocka, Maria ; Raha, Nancy ; Romatowski, Jacek ; Scherl, Ellen J ; Ziemek, Daniel ; Baniecki, Mary Lynn ; Longman, Randy ; Allegretti, Jessica R ; Vincent, Michael S ; Lepsy, Christopher ; Xi, Li ; Karlsson, Fridrik ; Schoenbeck, Uwe

Abstract:

Background:

The first-in-class treatment PF-06480605 targets the tumor necrosis factor-like ligand 1A (TL1A) molecule in humans. Results from the phase 2a TUSCANY trial highlighted the safety and efficacy of PF-06480605 in ulcerative colitis. Preclinical and in vitro models have identified a role for TL1A in both innate and adaptive immune responses, but the mechanisms underlying the efficacy of anti-TL1A treatment in inflammatory bowel disease (IBD) are not known.

Methods:

Here, we provide analysis of tissue transcriptomic, peripheral blood proteomic, and fecal metagenomic data from the recently completed phase 2a TUSCANY trial and demonstrate endoscopic improvement post-treatment with PF-06480605 in participants with ulcerative colitis.

Results:

Our results revealed robust TL1A target engagement in colonic tissue and a distinct colonic transcriptional response reflecting a reduction in inflammatory T helper 17 cell, macrophage, and fibrosis pathways in patients with endoscopic improvement. Proteomic analysis of peripheral blood revealed a corresponding decrease in inflammatory T-cell cytokines. Finally, microbiome analysis showed significant changes in IBD-associated pathobionts, Streptococcus salivarius, S. parasanguinis, and Haemophilus parainfluenzae post-therapy.

Conclusions:

The ability of PF-06480605 to engage and inhibit colonic TL1A, targeting inflammatory T cell and fibrosis pathways, provides the first-in-human mechanistic data to guide anti-TL1A therapy for the treatment of IBD.

2021-11-01·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association1区 · 医学

Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study

1区 · 医学

Article

作者: Schoenbeck, Uwe ; Scherl, Ellen J ; Banfield, Christopher ; Li, Gang ; Vincent, Michael S ; Neelakantan, Srividya ; Ye, Zhan ; Chandra, Deepa E ; Peeva, Elena ; Rath, Natalie ; Hung, Kenneth E ; Klopocka, Maria ; Romatowski, Jacek ; Hassan-Zahraee, Mina ; Danese, Silvio ; Lepsy, Christopher ; Allegretti, Jessica R

BACKGROUND & AIMS:

An immune component of inflammatory bowel disease is up-regulated tumor necrosis factor-like ligand 1A (TL1A). Anti-TL1A antibodies such as PF-06480605, a fully human immunoglobulin G1 monoclonal antibody, may have therapeutic potential.

METHODS:

This Phase 2a, multicenter, single-arm, open-label study (TUSCANY) evaluated safety, tolerability, efficacy, pharmacokinetics, and immunogenicity in PF-06480605-treated participants with moderate to severe ulcerative colitis (UC). Participants received 500 mg intravenous PF-06480605 every 2 weeks, 7 doses total, with a 3-month follow-up period. Primary safety and efficacy endpoints were the incidence of adverse events (AEs) and week 14 endoscopic improvement (EI) (Mayo endoscopic subscore = 0 or 1), respectively. Secondary endpoints included total soluble TL1A (free/drug-bound) (sTL1A), incidence of anti-drug and neutralizing antibodies, PF-06480605 concentrations, and changes in fecal calprotectin and high-sensitivity C-reactive protein. Histology was assessed at week 14.

RESULTS:

The study enrolled 50 participants; 42 completed. Of 109 treatment-emergent AEs, 18 were treatment-related. The most common AEs were UC disease exacerbation and arthralgia (6 participants each). Four serious AEs, no deaths, and no malignancies were reported. Week 14 EI was observed in a statistically significant proportion of participants (38.2% [uniformly minimum-variance unbiased estimator, per protocol population]). Minimal histologic disease was observed after treatment (Robarts Histopathology Index ≤5: 33.3%; Geboes Index ≤3.2: 47.6%). sTL1A increase over time from baseline indicated sustained target engagement. Forty-one participants (82%) tested positive for anti-drug antibodies and 5 (10%) for neutralizing antibodies.

CONCLUSIONS:

PF-06480605 demonstrated an acceptable safety profile and statistically significant EI in participants with moderate to severe UC, warranting further study in a larger participant cohort. Tissue histopathology analyses support this conclusion.

TRIAL REGISTRATION NUMBER:

https://clinicaltrials.gov/NCT02840721.

2020-04-01·British journal of clinical pharmacology2区 · 医学

First‐in‐human, randomized dose‐escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF‐06480605 in healthy subjects

2区 · 医学

Article

作者: Lepsy, Christopher ; Goteti, Kosalaram ; Pawlak, Sylvester ; Rudin, Dan ; Bhattacharya, Indranil ; Hung, Kenneth E. ; Hassan‐Zahraee, Mina ; Brown, Lisa S. ; Banfield, Christopher ; Li, Gang

Aims:

Human genetic, tissue expression, proteomics, transcriptomics and nonclinical studies implicate tumour necrosis factor α‐like ligand 1A (TL1A) as a novel target in inflammatory bowel disease (IBD). PF‐06480605, a fully human immunoglobulin G1 monoclonal antibody, targets TL1A. This first‐in‐human, Phase 1, dose‐escalation study assessed safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of intravenous (IV) and subcutaneous (SC) PF‐06480605 in healthy subjects (NCT01989143).

Methods:

Ninety‐two subjects were randomized to single ascending doses (SAD), PF‐06480605 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg or 800 mg IV, or multiple ascending doses (MAD), PF‐06480605 3 × 500 mg IV, or 3 × 30 mg, 3 × 100 mg, or 3 × 300 mg SC every 2 weeks for three doses, or placebo. Safety, tolerability, pharmacokinetics, immunogenicity profiles and total TL1A, anti‐drug antibody (ADA) and neutralizing antibody (NAb) levels were assessed at pre‐determined times.

Results:

PF‐06480605 SAD up to 800 mg IV and MAD up to 300 mg ×3 SC and 500 mg ×3 IV were well tolerated. Overall, there were 45 and 44 treatment‐emergent adverse events in SAD and MAD cohorts, respectively, and no deaths or serious adverse events. PF‐06480605 exposure generally increased dose‐dependently. ADA and NAb levels did not impact safety, pharmacokinetics, or pharmacodynamics at higher doses. Target engagement was demonstrated through dose‐dependent differences in serum total soluble TL1A concentrations for PF‐06480605 vs placebo cohorts.

Conclusions:

PF‐06480605 was generally well tolerated, and binding of soluble TL1A was maintained throughout the dose interval, supporting further study of PF‐06480605 in patients with IBD and other inflammatory conditions.

145

项与 Afimkibart 相关的新闻（医药）

2024-09-30

·医药观澜

罗氏1类新药在中国再获批2项临床！超70亿美元收购公司所得

中国国家药监局药品审评中心（CDE）官网近日最新公示，罗氏（Roche）申报的1类新药RO7790121注射液获批两项临床试验默示许可，拟开发治疗中度至重度溃疡性结肠炎。公开资料显示，这是一款靶向肿瘤坏死因子样细胞因子1A（TL1A）单抗，为罗氏以超71亿美元收购Telavant公司所得。该产品近期已经在美国启动3期临床试验，针对中度至重度溃疡性结肠炎适应症。 TL1A中文全称为肿瘤坏死因子（TNF）-样配体1A，在近年来受到行业广泛青睐。研究发现，TL1A在自身免疫性疾病中异常表达。从作用机制上来看，TL1A通过其DR3受体在肠道炎症级联和纤维化中起关键作用。因此，针对TL1A靶点的药物有望用于治疗溃疡性结肠炎、克罗恩病等多种自身免疫性疾病。 RO7790121注射液是一款抗TL1A单克隆抗体。该产品最初由Telavant公司（由Roivant公司和辉瑞共同成立）开发（此前研发代号：RVT-3101/PF-06480605）。2023年12月，罗氏完成对Telavant公司的收购，从而获得该产品在美国和日本开发、生产和商业化的权利，用于治疗炎症性肠病和潜在的多种其他疾病。同时，罗氏还将获得与辉瑞就下一代p40/TL1A定向双特异性抗体进行全球合作的选择，该抗体目前处于1期研究阶段。在该项合作中，罗氏将支付71亿美元的预付款和1.5亿美元的近期里程碑付款。根据研究人员此前公布的临床数据，在RO7790121注射液治疗溃疡性结肠炎患者的2b期临床试验中，接受3期临床试验预期剂量治疗的患者在56周时临床缓解率达到36%，比14周（29%）时进一步提升；获得内镜改善的患者比例在56周时达到50%，比14周（36%）时也有大幅度提高。根据ClinicalTrials官网，罗氏近日已经在美国开展了两项RO7790121注射液的3期临床研究，分别将评估RO7790121诱导和维持治疗中重度活动性溃疡性结肠炎的有效性和安全性（Ametrine-1研究）；评估RO7790121诱导治疗中至重度活动性溃疡性结肠炎的疗效和安全性（Ametrine-2研究）。在中国，此前辉瑞已经完成了该产品针对中度至重度溃疡性结肠炎成人受试者的2期临床研究。本次该产品在中国再次获批临床，意味着其即将进入新的临床开发阶段。 TL1A阻断剂目前已经成为一种治疗炎症性和纤维化疾病的潜在新疗法。除了罗氏，还有多家大型医药公司通过合作开发这类产品，可见对其临床应用潜力的认可。比如： 2023年6月，默沙东（MSD）以总额达108亿美元完成对Prometheus公司的收购，后者的核心产品正是一款靶向TL1A的单抗； 2023年10月，赛诺菲（Sanofi）宣布与Teva公司达成一项约10亿美元的协议，从而共同开发后者的TL1A抗体疗法TEV’574； 2024年6月，明济生物宣布与艾伯维（AbbVie）达成一项总金额约17.1亿美元的合作，从而共同开发处于临床前阶段的下一代TL1A抗体FG-M701，用于治疗炎症性肠病。希望随着研究的进展，针对该靶点的新药开发能取得更多突破，为患者带来更多的治疗选择。参考资料： [1]中国国家药监局药品审评中心官网.Retrieved Sep 27 , 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c [2]Roche Completes Acquisition of Telavant from Roivant, Including Rights to Novel TL1A Directed Antibody (RVT-3101) for the Treatment of Inflammatory Bowel Disease. Retrieved Dec 14，2024, From https://www.globenewswire.com/news-release/2023/12/14/2796336/34323/en/index.html 内容来源于网络，如有侵权，请联系删除。

并购申请上市引进/卖出

2024-09-26

·同写意

从2亿到12亿美金：一次中国首创新药的newco之旅

本届大会以“共建创新生态共赢产业未来”为主题，聚焦生物医药出海与国际化创新、创新药投融资、医疗器械等产业发展风向标，打造“高端化、国际化、专业化、立体化”的年度盛会。又一个“newco”（为某个药或者新技术成立的新公司）实现了被大公司收购的目标。一家专注于皮肤病学治疗的美国生物制药公司Dermavant，核心产品Vtama 乳膏在2016年授权买入自GSK，公司近日被Organon公司以高达12亿美元的价格收购。值得注意的是，GSK的Vtama实际上是来自中国的管线，在2012年海外权益被天济医药授权给GSK，Vtama乳膏的中文名是“本维莫德”，是早年间中国为数不多的first in class首创新药之一。至此，本维莫德的海外权益已被三次转手，价格由天济医药最初卖出的2亿美元到如今被装进Dermavant公司，作价12亿美元。 Dermavant是总部位于瑞士的全球性生物制药公司Roivant的子公司，这次交易可以说又是“newco专业户”Roivant的又一次大作。通过出售Dermavant，Roivant可以获得1.75亿美元的预付款，特应性皮炎适应证（AD）获得监管部门批准后，Organon还将支付7500万美元的里程碑付款，以及高达9.5亿美元的商业里程碑付款。 1.75亿美元的预付款，在美国从业者看来并不算高，但在中国的BD案例里已是一个相当不错的数字。“AD是个大适应证，而且这单从小在美国长大，他们是当作自个儿的药去交易的。”有从业者如此解释这次交易不低的交易金额。但这次交易和天济医药已经没有多大的关系。如今，本维莫德在国内的商业化权益属于冠昊生物，三年前进入医保目录，去年销售额不到5000万元人民币。在美国，FDA获批后，本维莫德一个季度就可卖出高于国内一年的销售额。在销售额之外，通过“newco”这个推进研发及管线包装、成立新公司寻求被收购的运作方式，本维莫德的标价超过了10亿美元。 1 艰难开局：在中国长出的FIC 本维莫德是一款银屑病外用药。这是一个大适应证，在中国又称“牛皮癣”，全世界有上亿患者，国内近700万。因此银屑病药物的国内布局也相当“卷”，光是IL-17A单抗，今年8月就有恒瑞和智翔金泰的两个药物上市，还有多家药企的产品处于临床三期阶段。天济医药本维莫德的优势在于，研发早、上市早，而且是原创的新药。2019年5月在中国上市时，和微芯生物的西达本胺、贝达生物的埃克替尼一起，被列为中国first in class药物的代表。在那之前，本维莫德的研发进程可谓坎坷。早年六十年代生人陈赓辉在加拿大西蒙弗雷泽大学读博时发现了本维莫德化合物，而后申请专利，于1999年在加拿大成立公司研发本维莫德，公司还曾在多伦多股票交易所上市。那几年，中国刚加入WTO，改革开放后第一批去往海外求学、工作的人陆续归国发展。海归潮持续了好几年，陈赓辉在2007年就以天济医药总裁的身份在中国申请本维莫德的IND，2009年获批。那个年代，中国医药界还是仿制药的天下，新药研发是一个还没有走通过“投入-回报”链路的新鲜事物，资本尚未聚集，法律法规也尚未健全。研发本维莫德的过程中，陈赓辉遇到了许多意想不到的坎坷。首先是临床试验受阻。陈赓辉找了几家顶级医院的皮肤科医生，都被拒绝，最后才找到了北京大学人民医院皮肤科主任张建中。张建中曾坦承也对陈赓辉有过怀疑，“这些年来我见过太多人声称自己能治愈牛皮癣。”但最终，他决定赌一把。此后，天济医药和北京大学人民医院合作，完成了本维莫德在国内三期的临床实验。这不是件容易的事，在2015年毕井泉担任国家药监局局长的药政改革之前，国内新药研发面临IND批件积压、药品审评标准与国际标准不符等问题，导致本维莫德的临床开发进程缓慢。支持临床开发的费用也是个问题。早期，陈赓辉曾接受国内一家钢厂老板的私人投资，以支持临床开发。后来，作为国内难得的first in class药物，本维莫德获得国家数百万元的资助。为了维持现金流、继续进行研发，陈赓辉还开始考虑将本维莫德的全球权益授予出去。本维莫德被GSK、强生等跨国公司看上，提出合作，但当时license out模式并不成熟，在国内监管层面曾遇到阻碍，而后影响了合作方报价。 2012年，天济医药将本维莫德的海外权益授予GSK的子公司，总价2.4亿美元。当年，为了规避监管层面的掣肘，陈赓辉还曾尝试与复星这个国内大型制药厂家合作，但国内厂家的新药研发业务也并不成熟，双方想法出现分歧，陈赓辉搬到上海努力了三个月后，最终这次合作没有走向成功。 2015年，本维莫德的三期实验终于接近尾声，但这时药政改革开始，治理临床数据造假的“722风暴”来临，陈赓辉团队花了几个月时间去检查数据，确保数据真实有效。 2016年，本维莫德在CDE提出上市申请，2019年终于通过优先审评审批程序获批上市，用于适合局部治疗的成人轻至中度稳定性寻常型银屑病。 2 不同走向在中国艰难孵化了多年的管线，在海外遇到“newco”，有了不一样的发展走向。在2016年-2019年等待NDA获批的三年间，2018年，GSK将本维莫德的海外权益转出，以3.3亿美元的价格卖给了Roivant的子公司Dermavant。 Roivant是前华尔街对冲基金经理、如今的美国总统候选人Vivek Ramaswamy在2014年成立的公司，标榜自己要“拯救制药业被遗忘的药物”。其不断从大药厂那里便宜“捡漏”，筛选出那些有潜力但不被大公司重视的管线，成立新公司、推进研发，最终推动新公司被大药厂收购而赚取回报。这就是“newco模式”的原型。 Roivant最有名的“战绩”，是2022年以4500万美元“捡漏”辉瑞的炎症性肠病管线RVT-3101，装进子公司Telavant中，2023年以70多亿美元的价格将Telavant转手卖给罗氏，获利至少50亿美元，回报超过100倍。 Dermavant是Roivant旗下专注做皮肤病的新公司。本维莫德被卖给GSK后，后者对其能够投入的资源有限，本维莫德在海外便被卷入了Roivant的“newco局”中，从此和国内版本的商业化前途产生了不同的走向。在国内，本维莫德2019年上市，2020年销售额4075.8万元，2021年正式进入国家医保目录并执行后降价72%，当年销售额落至2992.74万元。此后放量效应才逐渐突显，2023年的销售额终于超过了2020年进医保前的成绩——4943.85万元。在海外，Dermavant加速推动了本维莫德在美上市，于2022年通过了FDA的上市批准。当时本维莫德在美上市意义非凡：是我国先批准上市后再获FDA批准的首款创新药、美国25年来获批治疗银屑病的首款外用新分子实体药物等。在中美两个区域，本维莫德在银屑病外用乳膏市场的份额都是第一，但在银屑病激烈竞争的市场格局下，销量都不算太高。在美国，本维莫德今年二季度销售额1840万美元，还低于今年第一季度的1930万美元。业内人士指出，以本维莫德为核心产品的Dermavant，ROI可能没有达到Roivant期待的水平，且负债率较高。目前Roivant的核心管线包括子公司Immunovant的FcRn抗体，以及从辉瑞引进的两个药物，Roivant可能意在通过抛售Dermavant来调整组织架构，将力量集中在重点管线的开发上。美国药企之间的并购业务成熟，从默克分拆出去、商业化经验更为丰富的Organon也明显有信心能将本维莫德发展得更好。因此虽然本维莫德销售额目前并不高，但通过出售Dermavant公司，Roivant仍赚取了3.3亿美元买进核心管线、高达12亿美元卖出的差价。根据交易条款，Organon还将承担Dermavant高达2亿多美元的负债。而且，当本维莫德销售额超过10亿美元时，Roivant还将收取30%的特许权使用费。此外，Dermavant对于扩大本维莫德的适应证也做出过积极的努力。今年4月，FDA已经受理本维莫德的AD适应证申请，一旦获批，产品的市场空间将扩大四倍。这为Roivant后续赚取特许权使用费打下了很好的基础。 3 新药研发的养成游戏在“newco”模式的衬托下，中美“同药不同命”的特点再次突显了。从海外权益2012年首次转手给GSK算起，本维莫德的newco之旅兑现跨越了12年，管线价值翻6倍，销售额的差距也体现出两边市场的差别。兑现时间跨度更短的是恒瑞的一个TSLP管线，2500万美元预付款及近期里程碑付款的价格卖出海外权益，不到半年时间，便被Aiolos Bio转手卖给GSK，公司直接被后者收购，预付款是恒瑞当初管线预付款标价的40倍。看上去，恒瑞的案例说明的只是“卖管线”的方式不同、是否有包装和“做局”意识的区别。更直接的对比是，当管线发展到后期的上市阶段，拥有中国区权益和美国区权益的两边公司不同的发展走向，体现的便是同一款药在不同市场下的发展预期差距。日前康方生物发布其全球首创的PD-1/VEGF-A双抗依沃西最新数据，在一个适应证的头对头三期实验中打败K药。康方与其美国合作方Summit的股价都大涨，但一周内康方仅涨不到30%，Summit的涨幅超过160%，目前市值是康方的两倍有余，而其核心管线其实就是来自康方的依沃西。二者市值的差距，第一在于对药物销售市场的预判：两边市场定价，以及医保及商保支付的天花板；第二是对公司前景的预判：是单靠药物销售来实现业绩，还是公司有被高溢价收购的可能，以及股市的涨幅能高到什么程度？这当中影响因素复杂，涉及到整体社会的支付能力，医保及商保设计的成熟度；产业是否发展到有收购能力的大公司出现、有专门推动研发和管线包装并成立新公司的“newco”产业链出现；以及是否有一个上市退市规则透明健全、有充沛流动性的二级市场。无论如何，中国创新药的“好东西”仍在。有在美从业者称，在近期恒瑞、康诺亚、嘉和生物等公司主动做局成立“newco”后，美国的一级投资人更沉迷于找资产做newco，包括挖中国管线，挤兑效应由此出现，“以至于美国startup的公司非常惨”。但药物研发不存在什么“真金”，而更像是一场需要浇筑大量资金和其他资源的养成游戏。有了好的种子，拿努力和耐心培育只是基础。当本土的气候、土壤、水利资源条件产生变化，为了结出更好的果实，而尝试移植，是一种自然选择的结果。如果让好的种子能留在当地结成果实？这应该是下一步最重要的问题。参考文献： [1]Brian Yang. How To Make A Global FirstIn-Class Drug In China[EB/OL].https://scrip.citeline.com/SC098260/How-To-Make-A-Global-First-In-Class-Drug-In-China. 2017-5-17 [2]Jiang Wei, Li Danqing. First of its kind' treatment for psoriasis born in China[EB/OL].https://www.chinadaily.com.cn/a/201908/02/WS5d43f548a310cf3e355639c0.html. 2019-08-02 同写意媒体矩阵，欢迎关注↓↓↓

并购临床3期专利到期ASCO会议

2024-09-18

·FiercePharma

Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Vtama is now facing a major expansion opportunity into atopic dermatitis, which would triple the med’s eligible patient population. With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow.Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. Under the terms of the deal—which is expected to close in the fourth quarter—Organon will dish out an upfront payment of $175 million.Organon will also furnish Dermavant with a $75 million milestone payment contingent upon Vtama’s approval in atopic dermatitis (eczema), which is also expected in the last three months of 2024.Another $950 million is on the table for Dermavant based on the achievement of certain commercial milestones, the companies said. Plus, Organon will pay Dermavent shareholders tiered royalties on net sales. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis. The drug snagged its initial FDA greenlight in May 2022. While sales of Vtama scaled slowly last year, causing some analysts to temper their blockbuster expectations, Dermavant’s CEO, Todd Zavodnick, has remained confident that the drug will reach its full potential, telling Fierce in November that “[i]t’s not a matter of if, it’s when.”Vtama is nearing a major expansion opportunity in atopic dermatitis, which would triple the med’s eligible patient population. After posting a phase 3 eczema trial win in January, the Roivant unit filed for approval in adults and kids ages 2 years and up in late April. The FDA is expected to issue its verdict on the drug in atopic dermatitis sometime during the fourth quarter.Psoriasis affects more than 8 million people living in the U.S. over the age of 20 and 125 million people worldwide, Organon said. Atopic dermatitis, for its part, affects roughly 16.5 million adults and 9.6 million children in the U.S. According to Organon, women are impacted disproportionately by the skin conditions, with atopic dermatitis in particular linked to higher disease burden for women versus men.For Dermavant’s fiscal year ended March 31, Vtama brought home total sales of $75.1 million. Throughout the earnings period, Vtama steadily grew sales—from $13.7 million in the first quarter to $19.3 million in the fourth.As of May, 15,300 prescribers had written more than 385,000 Vtama prescriptions, according to a Roivant earnings release.Selling off its specialized subsidiaries is nothing new for Roivant.Last October, the company agreed to a $7.1 billion deal for Swiss pharma giant Roche to acquire Telavant and its investigational antibody for inflammatory bowel disease, RVT-3101. The acquisition closed in December.Meanwhile, Organon has been on a dealmaking streak of its own in recent months.Following the $50 million purchase of European rights to two Eli Lilly migraine medicines in December, Organon’s CEO, Kevin Ali, said the deal was “not a one-off,” during an earnings call in February.“There’s plenty in the queue that ultimately we can go after that are really nice opportunities for continuing revenue growth and [earnings] growth,” the CEO said at the time. In August, Organon upped its migraine accord with Lilly to the tune of $22.5 million, expanding its licensing pact to become the sole promoter and distributor of Emgality (included in the original EU deal) in Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates.

临床3期并购引进/卖出上市批准

100 项与 Afimkibart 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
溃疡性结肠炎	临床3期	-	Roche Holding AG	2023-10-23
克罗恩病	临床2期	-	Pfizer Inc.	2023-07-30
克罗恩病	临床2期	-	Telavant, Inc.	2023-07-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05107492 (CTgov)	临床1期	炎症性肠病	12	PF-06480605 (PF-06480605 450mg)	淵積廠獵窪餘夢糧壓夢(願願築淵夢製願選積簾) = 顧鑰壓膚顧夢窪齋鹽鏇糧醖醖糧鏇窪顧糧觸蓋 (鹽醖遞觸範獵繭繭鑰齋, 廠膚夢簾艱鏇醖鏇製選 ~ 築襯膚窪顧積選蓋製襯) 更多	-	2024-03-21
NCT05107492 (CTgov)	临床1期	炎症性肠病	12	placebo (Placebo)	選憲糧觸網鏇夢鹹遞夢(夢壓膚齋艱廠遞網願繭) = 鹹壓製淵鏇醖襯窪簾簾鹽遞艱糧衊夢範襯糧顧 (簾齋憲蓋窪衊選願選夢, 鹹觸積觸壓範構襯築觸 ~ 壓淵鏇選網鹽選壓襯構) 更多	-	2024-03-21
NCT04090411 (TUSCANY-2, Corporate Publications) 人工标引	临床2期	溃疡性结肠炎	-	RVT-3101	糧膚鹹醖衊襯淵鏇夢鏇(築窪選窪選網繭窪築簾) = 淵鏇選糧範網餘膚襯顧遞鏇簾鑰顧顧簾網壓鹹 (遞淵遞鹽遞艱鏇願鑰簾 ) 更多	积极	2023-06-22
NCT02840721 (Phase 2a, CTgov)	临床2期	溃疡性结肠炎	50	PF-06480605	衊夢願糧願夢鹽窪憲獵(選憲築選積繭憲鏇簾醖) = 廠鏇糧膚餘鹹願選襯艱壓襯壓壓繭襯鬱製餘願 (鑰網構窪觸餘窪鬱鹹衊, 鏇餘衊選膚構襯膚餘網 ~ 繭餘鏇膚醖遞鬱窪憲壓) 更多	-	2019-06-19