VBI疫苗宣布向欧洲药品管理局提交3抗原预防性乙型肝炎疫苗

StephenW

VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency
November 23, 2020 08:00 AM Eastern Standard Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.

“We believe our 3-antigen prophylactic hepatitis B vaccine has the potential to be an important intervention in the fight to eliminate Hepatitis B infections and this MAA submission is a significant milestone for the product and VBI more generally,” said Jeff Baxter, President & CEO. “We are committed to working collaboratively with the EMA throughout the regulatory process to provide access to this vaccine in Europe. As part of the global commercialization strategy for this vaccine, we also remain on track to submit the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the next couple of weeks.”

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.

About VBI’s 3-Antigen Hepatitis B Vaccine

This vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.

To learn more about VBI’s 3-antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/

StephenW

VBI疫苗宣布向欧洲药品管理局提交3抗原预防性乙型肝炎疫苗的销售授权申请
2020年11月23日，东部标准时间上午08:00

马萨诸塞州坎布里奇-（BUSINESS WIRE）-（美国商业资讯）-开发下一代传染病和免疫肿瘤疫苗的商业化生物制药公司VBI Vaccines Inc.（纳斯达克股票代码：VBIV）（VBI）今天宣布提交市场营销报告向欧洲药品管理局（EMA）申请该公司的3种抗原预防性乙型肝炎疫苗候选者的授权申请（MAA），以寻求批准预防成人由已知的所有乙型肝炎病毒亚型引起的感染。

“我们认为，我们的3-抗原预防性乙型肝炎疫苗有可能成为消除乙型肝炎感染的重要干预手段，而MAA的提交对于该产品和VBI而言是一个重要的里程碑，”总裁Jeff Baxter说道。首席执行官。 “我们致力于在整个监管过程中与EMA合作，以在欧洲提供使用这种疫苗的途径。作为该疫苗全球商业化策略的一部分，我们也有望在接下来的几周内向美国食品药品监督管理局（FDA）提交《生物制剂许可证申请》（BLA）。”

关于乙型肝炎

乙型肝炎是世界上最重大的传染病威胁之一，全球感染人数超过2.9亿。 HBV感染是肝脏疾病的主要原因，目前的治疗方法很难治愈，因为许多患者都在继续发展肝癌。每年估计有780,000人死于慢性HBV并发症，例如肝脏代偿失调和肝细胞癌。

关于VBI的3抗原乙肝疫苗

该疫苗是唯一的3-抗原性乙型肝炎疫苗，由乙型肝炎病毒的S，pre-S1和pre-S2表面抗原组成，并且已获批准在以色列使用并在市场上出售。 2017年12月，VBI在一项全球3期临床计划中启动了患者给药，该计划包括两项同时进行的关键性研究：PROTECT（一项安全性和免疫原性研究）和CONSTANT（一项批次间一致性研究）。分别于2019年6月和2020年1月公布的PROTECT研究和CONSTANT研究的数据构成了美国，欧洲和加拿大提交监管文件的基础。该疫苗在以色列以Sci-B-Vac®的名称出售。

要了解有关VBI的3-抗原乙型肝炎疫苗的更多信息，请访问：https://www.vbivaccines.com/sci-b-vac/