{"id":386604,"date":"2020-11-23T08:03:29","date_gmt":"2020-11-23T13:03:29","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=386604"},"modified":"2020-11-23T08:03:29","modified_gmt":"2020-11-23T13:03:29","slug":"vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/","title":{"rendered":"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency"},"content":{"rendered":"

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VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency<\/b><\/p>\n

CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–
\nVBI 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\u2019s 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.\n<\/p>\n

\n\u201cWe 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,\u201d said Jeff Baxter, President & CEO. \u201cWe 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.\u201d\n<\/p>\n

About Hepatitis B<\/b><\/p>\n

\nHepatitis B is one of the world\u2019s 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.\n<\/p>\n

About VBI\u2019s 3-Antigen Hepatitis B Vaccine <\/b><\/p>\n

\nThis 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\u00ae in Israel.\n<\/p>\n

\nTo learn more about VBI\u2019s 3-antigen Hepatitis B vaccine visit: https:\/\/www.vbivaccines.com\/sci-b-vac\/<\/a><\/p>\n

About VBI Vaccines Inc. <\/b><\/p>\n

\nVBI Vaccines Inc. (Nasdaq: VBIV<\/a>) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI\u2019s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI\u2019s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.<\/p>\n

\nWebsite Home: http:\/\/www.vbivaccines.com\/
\n<\/a>
News and Insights: http:\/\/www.vbivaccines.com\/wire\/
\n<\/a>
Investors: http:\/\/www.vbivaccines.com\/investors\/<\/a><\/p>\n

Cautionary Statement on Forward-looking Information <\/b><\/p>\n

\nCertain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, \u201cforward-looking statements\u201d). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company\u2019s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company\u2019s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company\u2019s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company\u2019s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 5, 2020, and filed with the Canadian security authorities at sedar.com on March 5, 2020, as may be supplemented or amended by the Company\u2019s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201123005591\/en\/<\/a><\/span><\/p>\n

VBI
\n<\/b>
Nicole Anderson
\n
Director, Corporate Communications & IR
\n
Phone: (617) 830-3031 x124
\n
Email: IR@vbivaccines.com<\/a><\/p>\n

KEYWORDS:<\/b> Europe United States North America Massachusetts<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research Infectious Diseases FDA Clinical Trials Biotechnology Health Pharmaceutical Science Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
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VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency 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\u2019s 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. \u201cWe 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 … <\/p>\n

Continue reading “VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-386604","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nVBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency 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\u2019s 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. \u201cWe 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 … Continue reading "VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-23T13:03:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20201123005591r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency\",\"datePublished\":\"2020-11-23T13:03:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/\"},\"wordCount\":1024,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20201123005591r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\\\/\",\"name\":\"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency - 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(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\u2019s 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. \u201cWe 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 … Continue reading \"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-23T13:03:29+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20201123005591r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency","datePublished":"2020-11-23T13:03:29+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/"},"wordCount":1024,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20201123005591r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/vbi-vaccines-announces-submission-of-marketing-authorization-application-for-3-antigen-prophylactic-hepatitis-b-vaccine-to-the-european-medicines-agency\/","name":"VBI Vaccines Announces Submission of Marketing Authorization Application for 3-Antigen Prophylactic Hepatitis B Vaccine to the European Medicines Agency - 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