Samsung Biologics and Vir Biotechnology, Inc. today announced a manufacturing agreement under which Samsung Biologics will perform large scale manufacturing services for Vir's SARS-CoV-2 monoclonal antibody program.
"We are proud to be working as a partner with Vir in their response to the global COVID-19 pandemic," said Dr. Tae Han Kim, CEO of Samsung Biologics. "With millions of people being impacted by this virus, accessibility to effective treatment is paramount. Vir's candidate molecules supported by Samsung Biologics' production scale have the potential to bring hope to countless lives across nations suffering from COVID-19."
Vir's lead SARS-CoV-2 mAb development candidates, VIR-7831 and VIR-7832, have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays. Vir plans to proceed directly into a phase 2 clinical trial within the next three to five months. Today's agreement builds on Vir's previously announced manufacturing agreement with WuXi Biologics (stock code: 2269.HK) and its letter of intent with Biogen, Inc. (Nasdaq: BIIB).
"Given the trajectory of the COVID-19 pandemic, our expectation is that there will be a significant need around the world for antibody therapies," said George Scangos, Ph.D., CEO, Vir. "Accordingly, we are taking proactive steps to reserve large scale manufacturing capacity to be ready to move quickly with any of our antibody candidates that prove to be clinically safe and effective. We are pleased to partner with Samsung Biologics who share our commitment to work with exceptional speed to address this pandemic."
Under the deal valued at approximately $362 million, Samsung Biologics is expected to commence its manufacturing as early as October with the first engineering run, with potential commercial batches to be manufactured starting in 2021 in Plant 3. The parties will continue to negotiate additional terms in a definitive agreement and will use best efforts to execute a definitive agreement before July 31, 2020.
About Samsung Biologics Co.,Ltd.
Established in 2011 and headquartered in Songdo, South Korea, Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With a proven regulatory approvals record, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.
About Vir Biotechnology, Inc.
Vir Biotechnology, Inc. (Nasdaq: VIR) is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus, and tuberculosis. For more information, please visit www.vir.bio.
Vir Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "explore," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of Vir's collaborations with Samsung, Wuxi Biologics and Biogen, the completion of a definitive agreement with Samsung, the timing and scale of manufacturing activities, the demand for antibody therapies, the timing of commencement of clinical trials for Vir's antibody product candidates and Vir's ability to address the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results including unexpected results during clinical trials, difficulties in obtaining regulatory approval, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays or disruptions in Vir's business or clinical trials due to the COVID-19 pandemic, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Samsung Biologics Forward-Looking Statements
This press release contains certain statements that constitute forward-looking statements, including statements that describe Samsung Biologics' objectives, plans or goals. All such forward-looking statements, and the assumptions on which they are based, are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. There can be no assurance that the results and events contemplated by the forward-looking statements contained herein will in fact occur. Except as required by law, Samsung Biologics will not update any forward-looking statements to reflect material developments that may occur after the date of this press release.
Contact:Samsung BiologicsPress: [email protected]
Vir Biotechnology, Inc.
InvestorsNeera Ravindran, MDHead of Investor Relations & Strategic Communications[email protected] +1-415-506-5256
MediaLindy DevereuxScient PR[email protected] +1-646-515-5730
SOURCE Samsung Biologics; Vir Biotechnology
三星生物技术和 Vir Biotechnology , Inc .今天宣布了一项生产协议，根据该协议，三星生物将为 Vir 的 SARS-CoV-2单克隆抗体项目提供大规模制造服务。
三星生物科技首席执行官 TaeHanKim 博士说：“我们很自豪能与 Vir 合作，共同应对全球 COVID-19大流行。”“随着数百万人受到这种病毒的影响，获得有效治疗至关重要。在三星生物技术公司生产规模的支持下， Vir 的候选分子有可能给遭受 COVID-19折磨的国家带来无数的希望。”
病毒的主要 SARS-CoV-2mAb 发展候选者 VIR-7831和 VIR-7832对 SARS-CoV-2尖峰蛋白表现出高度的亲和力，在活病毒细胞检测中对 SARS-CoV-2的中和作用非常强。Vir 计划在未来三到五个月内直接进入2期临床试验。今天的协议建立在 Vir 公司之前宣布的与药明生物（股票代码：2269.HK ）的生产协议及其与百健（Biogen）公司（ Nasdaq ： BIIB ）的意向书之上。
“考虑到 COVID-19大流行的发展轨迹，我们预计全球对抗体治疗的需求将会很大，” Vir 首席执行官 George Scanggos 博士说。“因此，我们正在采取积极措施，以储备大规模的制造能力，准备迅速行动与我们的抗体候选人，证明临床安全和有效。我们很高兴与三星生物技术公司合作，他们共同致力于以极快的速度应对这一流行病。”
三星生物技术（ KRX ：207940.KS ）成立于2011年，总部位于韩国松多，是一家完全集成的 CDMO ，提供最先进的合同开发、制造和实验室测试服务。三星生物凭借成熟的监管审批记录、最大的产能、最快的吞吐量，是一家屡获殊荣的首选合作伙伴，在满足全球生物制药公司不断发展的需求的同时，能够在每个工艺阶段支持生物制剂产品的开发和制造。有关详细信息，请访问 www.samsungbiologics.com 。
关于 Vir Biotechnology , Inc .
Vir Biotechnology , Inc .( Nasdaq : VIR )是一家临床阶段免疫学公司，专注于结合免疫学见解和尖端技术治疗和预防严重传染病。病毒已经组装了四个技术平台，旨在通过利用对自然免疫过程的关键观察来刺激和增强免疫系统。其目前的开发管线由针对乙肝病毒、甲型流感、 SARS-CoV-2、人免疫缺陷病毒、结核的产品候选者组成。详情请访问 www.vir.bio 。
本新闻稿包含前瞻性陈述的含义是1995年私人证券诉讼改革法案。诸如“可能”、“将”、“计划”、“潜在”、“探索”、“有希望”和类似表达（以及参考未来事件、条件或情况的其他词语或表达）等词语旨在识别前瞻性陈述。这些前瞻性陈述基于 Vir 公司截至本新闻稿发布之日的预期和假设。每个前瞻性陈述都涉及风险和不确定性。实际业绩可能与这些前瞻性陈述存在重大差异。本新闻稿中包含的前瞻性声明包括关于 Vir 公司与三星、无锡生物技术公司和百健（Biogen）公司合作的潜在利益、与三星公司达成最终协议、生产活动的时间和规模、抗体治疗的需求、病毒抗体产品候选药物临床试验的开始时间和病毒处理当前 COVID-19大流行和未来疾病暴发的能力。许多因素可能导致目前预期与实际结果之间的差异，包括临床试验期间的意外结果、难以获得监管批准、临床现场活化率或临床试验注册率低于预期、预期或现有竞争的变化。由于 COVID-19大流行，病毒业务或临床试验延迟或中断，以及意外诉讼或其他纠纷。Vir 公司向美国证券交易委员会提交的文件中讨论了可能导致实际结果与本新闻稿中前瞻性陈述中表达或暗示的结果不同的其他因素，包括其中“风险因素”一节。除法律要求外， Vir 不承担更新包含在此的任何前瞻性陈述以反映预期的任何变化的义务，即使有新的信息可用。
Vir Biotechnology , Inc .
投资者关系与战略沟通 MDHeader Neera Ravindran [受电子邮件保护]+1-415-506-5256
MediaLindy DevereuxScient PR [受电子邮件保护]+1-646-515-5730