AstraZeneca to Recover the Global Rights to Brazikumab from Allergan

阿斯利康(AstraZeneca)从艾尔建(Allergan)收回 Brazikumab 的全球权利

2020-02-14 12:40:11 Drugs

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27 January 2020 -- AstraZeneca will recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. Brazikumab is currently in a Phase IIb/III programme in Crohn’s disease (CD)1 and a Phase IIb trial in ulcerative colitis (UC).2 AstraZeneca and Allergan will terminate their existing license agreement and all rights to brazikumab will revert to AstraZeneca. The transaction is expected to complete in the first quarter of 2020, subject to regulatory approvals associated with AbbVie’s proposed acquisition of Allergan and its timely completion. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We’re pleased to bring brazikumab back into the AstraZeneca pipeline. With our expanding presence in immunology, there is an opportunity to address a significant unmet need in inflammatory bowel diseases where the majority of patients are unable to achieve clinical remission with current treatment options. This agreement creates an opportunity for us to complete the full development programme and bring this potential new treatment option to patients as quickly as possible.” AstraZeneca’s mid to late-stage pipeline of biologic medicines in respiratory and immunology includes Fasenra (benralizumab) which is being evaluated in eight eosinophil-driven diseases beyond severe asthma, tezepelumab in Phase III development for severe, uncontrolled asthma, anifrolumab for the treatment of systemic lupus erythematosus which is being prepared for regulatory submission in the second half of 2020, and MEDI3506 (IL33 monoclonal antibody), a potential new medicine for the treatment of dermatological and other diseases entering Phase II trials. Financial considerations Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of development for brazikumab in CD and UC, including the development of a companion diagnostic.  Pursuant to the 2012 collaboration between Amgen and AstraZeneca to jointly develop and commercialise a clinical-stage inflammation portfolio, Amgen is entitled to receive a high single-digit to low double-digit royalty on sales of brazikumab if approved and launched. This includes the original inventor royalty. Other than this, AstraZeneca will own all rights and benefits arising from the product with no other payments due to Amgen. Brazikumab Brazikumab is a monoclonal antibody that binds to the IL23 receptor and is in development for CD and UC with a companion biomarker. Brazikumab selectively blocks the IL23 immune signal, preventing intestinal inflammation. In Phase II trials, it demonstrated a clinical effect at week eight in tumour necrosis factor-resistant CD patients.3 The Phase IIb/III INTREPID programme is underway to assess brazikumab compared to placebo or adalimumab in CD. The Phase II EXPEDITION trial is underway to assess brazikumab compared to placebo or vedolizumab in UC. With current biologic medicines, 40% to 55% of patients have no response to therapy, and 65% to 80% of patients do not experience a full remission.4 AstraZeneca’s development of brazikumab originates from the 2012 collaboration with Amgen mentioned above. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca. Source: AstraZeneca Posted: January 2020
2020年1月27日----阿斯利康(AstraZeneca)将从艾尔建(Allergan)公司收回针对 IL23的单克隆抗体 Branikub (原 MEDI2070)的全球权利。Brazikumab 目前正在克罗恩病( CD )1的 IIb / III 期方案和溃疡性结肠炎( UC )的 IIb 期试验中。2 AstraZeneca 和艾尔建(Allergan)将终止其现有的许可协议, Branikumab 的所有权利将恢复到阿斯利康(AstraZeneca)。本次交易预计于2020年第一季度完成,尚需获得与艾伯维(AbbVie)拟收购艾尔建(Allergan)相关的监管批准及其及时完成。 BioPharmaceuticals 研发执行副总裁 Mene Pangalos 表示:“我们很高兴将 Branikub 带回阿斯利康(AstraZeneca)的管道。随着免疫学的发展,我们有机会解决炎症性肠病中未得到满足的重大需求,因为大多数患者无法通过目前的治疗方案达到临床缓解。这一协议为我们提供了一个机会,使我们能够完成整个开发计划,并尽快为患者带来这一潜在的新治疗方案。” 阿斯利康(AstraZeneca)在呼吸和免疫学方面的生物药物的中晚期管道包括 Fasenna ( benralizumab ),该管道目前正在评估8种嗜酸性粒细胞病毒驱动的疾病,这些疾病包括严重哮喘、特珠单抗在第三阶段开发用于严重的非受控哮喘。用于治疗系统性红斑狼疮的苯胺类药物正在准备于2020年下半年提交监管机构,以及用于治疗进入 II 期试验的皮肤病和其他疾病的新药 MEDI3506( IL33单克隆抗体)。 财务考虑因素 根据终止协议,艾尔建(Allergan)将提供最多不超过商定数额的资金,估计为阿斯利康(AstraZeneca)在 CD 和 UC 完成 Branikub 开发之前预计将承担的全部费用,包括开发配套诊断。 根据安进与阿斯利康(AstraZeneca)2012年合作,共同开发和商业化临床阶段炎症产品组合,安进(Amgen)有权获得高个位数至低两位数的巴西木乃布销售提成(如获批准并上市)。这包括原始发明者的版税。除此之外,阿斯利康(AstraZeneca)将拥有该产品产生的所有权利和利益,且无其他应付安进(Amgen)款项。 Brazikumab Brazikumab 是一种单克隆抗体,与 IL23受体结合,正在研制 CD 和 UC 及其伴生生物标志物。Brazikumab 选择性阻断 IL23免疫信号,预防肠道炎症。在 II 期试验中,它显示了在第8周肿瘤坏死因子耐药的 CD 患者的临床效果。3 IIb / III 期 INTREID 方案正在进行中,以评估与 CD 中的安慰剂或阿达木单抗相比的巴西单抗。第二阶段的 EXEDITION 试验正在进行中,目的是评估与 UC 的安慰剂或 vedolizumab 相比的 Branikub 。有了目前的生物药,40%至55%的患者对治疗没有反应,65%至80%的患者没有完全缓解。4阿斯利康(AstraZeneca)对巴西木乃伊的开发源于2012年与上述安进(Amgen)的合作。 阿斯利康(AstraZeneca)公司 阿斯利康(AstraZeneca)( LSE / STO / NYSE : AZN )是一家全球性的、以科学为主导的生物制药公司,专注于处方药的发现、开发和商业化,主要用于治疗肿瘤、心血管、肾代谢和呼吸三个治疗领域的疾病。阿斯利康(AstraZeneca)在100多个国家开展业务,其创新药物被全球数百万患者使用。请访问阿斯利康。在 Twitter @ AstraZeneca 上跟踪公司。 资料来源:阿斯利康(AstraZeneca) Posted :2020年1月

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