澳门在线赌城娱乐 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

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.

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

澳门在线赌城娱乐 has entered into a global development and commercialisation collaboration agreement with Daiichi Sankyo Company, 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 澳门在线赌城娱乐’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, 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.

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. 澳门第一赌城在线娱乐很荣幸能与Daiichi Sankyo合作, a long-term collaborator of 澳门在线赌城娱乐 in other disease areas.”

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, a company with a wealth of global experience and expertise in oncology, we will combine our respective skill sets to maximise the value of trastuzumab deruxtecan and accelerate the establishment of our global oncology business. 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 has been designed to deliver chemotherapy selectively to cancer cells and reduce systemic exposure, 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, the strength of the overall response rate and durability of response in patients previously treated with trastuzumab emtansine for 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, 澳门在线赌城娱乐 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, certain countries in Europe and certain other markets where Daiichi Sankyo has affiliates. 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.

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. 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 $3.5bn, 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. 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.

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 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. Fast Track Designation was also granted in the US for the treatment of 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. 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 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 also updates the presentation of Total Revenue within its Statement of Comprehensive Income. 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, Externalisation Revenue only included income arising from transactions involving 澳门在线赌城娱乐’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. 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.

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.

关于澳门在线赌城娱乐

澳门在线赌城娱乐是一家全球性的, 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.