澳门葡京网赌游戏 and Daiichi Sankyo enter collaboration for novel HER2 -targeting antibody-drug conjugate

2019年3月28日23:30 GMT

这份公告包含内幕消息

根据本文提及的股权配售拟发行的证券将不会也没有根据1933年美国证券法进行注册, 修订的, 在没有注册或注册要求豁免的情况下，不得在美国提供或销售.

Companies to accelerate and expand development of trastuzumab deruxtecan across breast and other cancers, 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

澳门葡京网赌游戏与Daiichi Sankyo公司签署了一项全球开发和商业化合作协议, Limited (Daiichi Sankyo) for trastuzumab deruxtecan (DS-8201), a proprietary antibody-drug conjugate (ADC) and potential new targeted medicine for cancer treatment.

The collaboration is aligned with 澳门葡京网赌游戏’s science-led strategy in 肿瘤学, which is based on four key scientific platforms: tumour drivers & 耐药，DNA损伤反应，免疫肿瘤学和adc.

Trastuzumab deruxtecan is currently in development for the treatment of multiple HER2-expressing cancers, including breast and gastric cancer, and in patients with HER2低表达. In 2017, 曲妥珠单抗德鲁德替康被美国FDA授予突破性疗法称号，用于治疗 HER2艾滋病患者, 接受曲妥珠单抗和帕妥珠单抗治疗的局部晚期或转移性乳腺癌，曲妥珠单抗emtansine治疗后疾病进展.

计划于2019年下半年为晚期或难治性乳腺癌患者提交首次监管申请. 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.

The companies will jointly develop and commercialise trastuzumab deruxtecan worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

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. In addition, it has the potential to redefine breast cancer treatment as the first therapy for HER2-低表达肿瘤. 它也有可能治疗他人 HER2突变或 HER2-overexpressing cancers, including lung and colorectal cancers. 澳门葡京赌博游戏很荣幸能与Daiichi Sankyo合作, a long-term collaborator of 澳门葡京网赌游戏 in other disease areas.”

乔治Nakayama, 代表董事, Daiichi Sankyo的董事长兼首席执行官, 他说:“曲妥珠单抗是澳门葡京赌博游戏对科学技术的不懈追求创造的肿瘤学产品线中的旗舰资产, 澳门葡京赌博游戏公司最重要的优势. 通过与澳门葡京网赌游戏的战略合作, a company with a wealth of global experience and expertise in oncology, 澳门葡京赌博游戏将结合各自的技能，最大限度地发挥曲妥珠单抗德鲁德康的价值，并加速澳门葡京赌博游戏全球肿瘤业务的建立. By aiming to provide new treatment options across a wide range of cancers as soon as possible, we will maximise our contribution to patients with cancer and their families around the world.”

采用第一三共DXd专有ADC技术, Trastuzumab deruxtecan被设计用于选择性地向癌细胞提供化疗并减少全身暴露, 与传统化疗相比. Data from the ongoing first-time-in-human trial shows strong activity in a number of tumour types. 特别是, 先前接受曲妥珠单抗emtansine治疗的患者的总体缓解率和缓解持久性的强度 HER2艾滋病患者 metastatic breast cancer formed the basis for the Breakthrough Therapy Designation.¹

金融方面的考虑

Under the terms of the agreement, 澳门葡京网赌游戏 will pay Daiichi Sankyo an upfront payment of $1.35bn, half of which is due upon execution, with the remainder payable 12 months later.

或有付款不超过5美元.550亿美元包括3亿美元.8bn for potential successful achievement of future regulatory and other milestones, as well as $1.750亿美元用于销售相关里程碑.

整体, the transaction will be accounted for as an intangible asset acquisition, recognised initially at the present value of non-contingent consideration, with future milestones capitalised into the intangible asset as they are recognised. 澳门葡京网赌游戏和第一三共将在全球范围内平均分担曲妥珠单抗德鲁德康的开发和商业化成本以及利润, 除了日本.

第一三共将在美国创下销量纪录, certain countries in Europe and certain other markets where Daiichi Sankyo has affiliates. 继以下财务报告公告, 与澳门葡京网赌游戏分享的利润将由澳门葡京网赌游戏计入合作收入(见下文), “财务报告陈述”).

澳门葡京网赌游戏预计将在全球所有其他市场记录产品销售，其中与Daiichi Sankyo共享的利润将作为销售成本核算.

The transaction is expected to be neutral to core earnings in 2019, with growing Core EPS accretion from 2020 and making a significant contribution in 2023. 交易没有结束条件. The collaboration agreement will become effective on 29 March 2019. 该交易和融资安排不会影响公司2019年2月14日发布的2019年财务指引.

这笔交易的预付款和近期里程碑将由约3美元的新股配售所得资金提供.5bn, of which more than half will be used to fund this transaction and the ongoing collaboration. A separate announcement will be issued by the Company today on the equity placement.

For the purposes of the UK Listing Authority's Listing Rule LR 10.4.1 R(第2类交易通知书), the value of gross assets acquired with the transaction is estimated to be $1.50亿年和, 鉴于药物的发展阶段, a pre-tax loss of $38m was attributable to trastuzumab deruxtecan during the year to 31 March 2018.

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. adc是一种靶向抗癌药物，通过与单克隆抗体连接的连接体将细胞毒性药物传递给癌细胞，单克隆抗体与癌细胞上表达的特定靶标结合.

A broad and comprehensive development programme with trastuzumab deruxtecan is underway in North America, 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-expressing advanced colorectal cancer and metastatic non-squamous HER2-overexpressing或 HER2-mutated NSCLC, and Phase I development in combination with nivolumab for HER2表达转移性乳腺癌和膀胱癌.

Trastuzumab deruxtecan于2017年被美国FDA授予突破性疗法称号，用于治疗 HER2艾滋病患者, 接受曲妥珠单抗和帕妥珠单抗治疗的局部晚期或转移性乳腺癌，曲妥珠单抗emtansine治疗后疾病进展. Fast Track Designation was also granted in the US for the treatment of HER2 -阳性不可切除和/或转移性乳腺癌患者在先前的治疗后进展 HER2靶向药物，包括曲妥珠单抗emtansine. Trastuzumab deruxtecan has received Sakigake designation for the treatment of HER2艾滋病患者 advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, 劳工及福利.

Trastuzumab deruxtecan是一种潜在的新药，尚未在任何国家获得任何适应症批准. 安全性和有效性尚未确定.

财务报告列报

因为这个公告, 澳门葡京网赌游戏 also updates the presentation of Total Revenue within its Statement of Comprehensive Income. 这将从2019年1月1日起生效，并将反映在公司计划于2019年4月26日发布的2019年第一季度财务业绩中.

In 2015, 公司宣布改变其综合收益表中总收入的列报方式，以包括外部性收入. 今天的公告承认了合作对澳门葡京网赌游戏日益增长的重要性，并将使这些合作产生的收入在总收入中得到确认. 合作的相关费用将在综合收益表的适当费用项目中确认.

从历史上看, Externalisation Revenue only included income arising from transactions involving 澳门葡京网赌游戏’s medicines. 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. 更新后的合作收入类别还将包括由澳门葡京网赌游戏获得药物权益并与卖方积极合作的交易产生的类似性质的收入.

No prior year restatement of financial results will be required as a result of this change. The change in accounting presentation does not impact the Company’s revenue guidance for 2019.

关于澳门葡京网赌游戏

澳门葡京网赌游戏是一家全球性的, 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 - 肿瘤学, 心血管, 肾 & 代谢与呼吸. 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. 欲了解更多信息，请访问 澳门葡京网赌游戏.com 并在推特上关注澳门葡京赌博游戏 @澳门葡京网赌游戏.

联系人

艾德里安·坎普
公司秘书
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参考文献

1. Iwata H等人. Trastuzumab Deruxtecan (DS-8201a)用于her2表达实体瘤患者:一项大型1期研究的长期结果. 发表于美国临床肿瘤学会. 美国芝加哥. 2018年6月1日.