澳门在线赌城娱乐和Daiichi Sankyo开始合作开发新的her2靶向抗体-药物偶联物

2019年3月28日23:30 GMT

这份公告包含内幕消息

The securities proposed to be offered pursuant to the equity placing referred to herein will not be and have not been registered under the US Securities Act of 1933, 修订的, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

公司将加速和扩大曲妥珠单抗德鲁德替康治疗乳腺癌和其他癌症的开发, 有可能重新定义护理标准

通过股权配售融资约3美元.5bn

Guidance for 2019 Core Earnings Per Share remains unchanged; growing accretion from 2020 to a significant contribution in 2023

澳门在线赌城娱乐 has entered into a global development and commercialisation collaboration agreement with Daiichi Sankyo Company, trastuzumab deruxtecan (DS-8201), 一种专有的抗体-药物偶联物(ADC)和潜在的癌症治疗新靶向药物.

此次合作符合澳门在线赌城娱乐在肿瘤学领域以科学为主导的战略, 这是基于四个关键的科学平台:肿瘤驱动因素 & 耐药，DNA损伤反应，免疫肿瘤学和adc.

Trastuzumab deruxtecan目前正在开发用于治疗多发性疾病 HER2-表达的癌症，包括乳腺癌和胃癌，以及患有 HER2低表达. In 2017, trastuzumab deruxtecan was granted Breakthrough Therapy Designation by the US FDA for the treatment of patients with HER2艾滋病患者, locally-advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after trastuzumab emtansine.

A first regulatory submission is scheduled for the second half of 2019 for patients in the advanced or refractory breast cancer setting. 乳腺治疗的进一步发展, 非小细胞肺癌(NSCLC), 胃癌和结直肠癌正在发生.

两家公司将联合开发曲妥珠单抗，并在全球范围内商业化, 除了在日本，第一三共将保持专有权. 第一三共将全权负责制造和供应.

帕斯卡Soriot, 首席执行官, said: “We believe that trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2 -乳腺癌和胃癌呈阳性. 此外，它有可能重新定义乳腺癌治疗作为第一疗法 HER2-低表达肿瘤. 它也有可能治疗他人 HER2突变或 HER2-过度表达癌症，包括肺癌和结直肠癌. 澳门第一赌城在线娱乐很荣幸能与Daiichi Sankyo合作, 澳门在线赌城娱乐在其他疾病领域的长期合作伙伴.”

乔治Nakayama, 代表董事, Daiichi Sankyo的董事长兼首席执行官, said: “Trastuzumab deruxtecan is the flagship asset in our oncology pipeline created by our relentless pursuit of science and technology, 澳门第一赌城在线娱乐公司最重要的优势. 通过与澳门在线赌城娱乐的战略合作, 一家在肿瘤学领域拥有丰富全球经验和专业知识的公司, we will combine our respective skill sets to maximise the value of trastuzumab deruxtecan and accelerate the establishment of our global oncology business. 澳门第一赌城在线娱乐的目标是尽快为多种癌症提供新的治疗方案, 澳门第一赌城在线娱乐将最大限度地为世界各地的癌症患者及其家属做出贡献.”

采用第一三共DXd专有ADC技术, trastuzumab deruxtecan has been designed to deliver chemotherapy selectively to cancer cells and reduce systemic exposure, 与传统化疗相比. 正在进行的首次人体试验的数据显示，该药物在许多肿瘤类型中都有很强的活性. 特别是, the strength of the overall response rate and durability of response in patients previously treated with trastuzumab emtansine for HER2-阳性转移性乳腺癌形成了突破性疗法称号的基础.¹

金融方面的考虑

根据协议条款，澳门在线赌城娱乐将向Daiichi Sankyo支付1美元的预付款.350亿美元，其中一半在执行时到期，其余在12个月后支付.

或有付款不超过5美元.550亿美元包括3亿美元.80亿美元用于未来可能成功实现的监管和其他里程碑，以及1亿美元.750亿美元用于销售相关里程碑.

整体, 该交易将作为无形资产收购记帐, 按非或有对价现值初始确认, 未来的里程碑在确认时资本化为无形资产. 澳门在线赌城娱乐 and Daiichi Sankyo will share equally development and commercialisation costs as well as profits from trastuzumab deruxtecan worldwide, 除了日本.

第一三共将在美国创下销量纪录, 在欧洲的某些国家和Daiichi Sankyo有分支机构的某些其他市场. 继以下财务报告公告, profits shared with 澳门在线赌城娱乐 will be accounted for as Collaboration Revenue by 澳门在线赌城娱乐 (see further below, “财务报告陈述”).

澳门在线赌城娱乐 is expected to record Product Sales in all other markets worldwide for which profits shared with Daiichi Sankyo will be accounted for as cost of goods sold.

该交易预计将对2019年的核心收益产生中性影响, 核心每股收益将从2020年开始增长，并在2023年做出重大贡献. 交易没有结束条件. 该合作协议将于2019年3月29日生效. The transaction and funding arrangements do not impact the Company’s financial guidance for 2019 as published on 14 February 2019.

The upfront payment and near-term milestones under the transaction will be funded from the proceeds of a new equity placement of approximately $3.50亿美元，其中一半以上将用于这笔交易和正在进行的合作. 本公司将于今日另行发布配售公告.

根据英国上市管理局的《澳门第一赌城在线娱乐》第LR 10条.4.1 R(第2类交易通知书), 该交易获得的总资产价值估计为1美元.50亿年和, 鉴于药物的发展阶段, 截至2018年3月31日，曲妥珠单抗德鲁德替康的税前亏损为3800万美元.

关于曲妥珠单抗德鲁特康

Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in US only) is the lead potential new medicine in the ADC franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic agents to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

一项广泛而全面的曲妥珠单抗德鲁德替康开发计划正在北美进行, 欧洲和亚洲, 包括五项关键试验 HER2-表达乳腺癌和胃癌. Trastuzumab deruxtecan也处于II期开发 HER2-表达晚期结直肠癌和转移性非鳞状 HER2-overexpressing或 HER2-突变的NSCLC，以及联合纳武单抗的I期研究 HER2表达转移性乳腺癌和膀胱癌.

Trastuzumab deruxtecan was granted Breakthrough Therapy Designation in 2017 by the US FDA for the treatment of patients with HER2艾滋病患者, locally-advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after trastuzumab emtansine. 快速通道指定也被授予在美国治疗 HER2 -positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2靶向药物，包括曲妥珠单抗emtansine. 曲妥珠单抗德uxtecan已获得Sakigake指定治疗 HER2-阳性的晚期胃癌或胃食管结癌, 劳工及福利.

Trastuzumab deruxtecan is a potential new medicine that has not been approved for any indication in any country. 安全性和有效性尚未确定.

财务报告列报

因为这个公告, 澳门在线赌城娱乐还在其综合收益表中更新了总收入的列报. This is effective from 1 January 2019 and will be reflected in the Company’s Q1 2019 financial results that are intended for publication on 26 April 2019.

In 2015, the Company announced a change to the presentation of Total Revenue within its Statement of Comprehensive Income to include Externalisation Revenue. Today’s announcement recognises the growing importance of collaborations to 澳门在线赌城娱乐 and will result in income arising from those collaborations being recognised within Total Revenues. The associated costs of collaborations will be recognised in the appropriate expense lines in the Statement of Comprehensive Income.

从历史上看, 外部性收入仅包括涉及澳门在线赌城娱乐药品交易产生的收入. 这些收入包括预付款, 里程碑收据和版税, 还有其他合作收入. The updated category of Collaboration Revenue will also include income of a similar nature arising from transactions where 澳门在线赌城娱乐 has acquired an interest in a medicine and entered into an active collaboration with the seller.

由于这一变动，不需要对上一年的财务结果进行重述. 会计列报的变化不会影响公司2019年的收入指引.

关于澳门在线赌城娱乐

澳门在线赌城娱乐是一家全球性的, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, 心血管, 肾 & 代谢与呼吸. 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 欲了解更多信息，请访问 澳门在线赌城娱乐.com 并在推特上关注澳门第一赌城在线娱乐 @澳门在线赌城娱乐.

联系人

艾德里安·坎普
公司秘书
澳门在线赌城娱乐

参考文献

1. Iwata H等人. Trastuzumab Deruxtecan (DS-8201a) in Subjects with HER2 -expressing Solid Tumors: Long-term Results of a Large Phase 1 Study with Multiple Expansion Cohorts. 发表于美国临床肿瘤学会. 美国芝加哥. 2018年6月1日.