VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), an immunology-focused biopharmaceutical company pursuing potent disease prevention and treatment, today announced that the European Commission (EC) has granted marketing authorization for PreHevbri™ [vaccin contre l’hépatite B (recombinant, adsorbé)] promoting active immunization against infection caused by all known subtypes of hepatitis B virus (HBV) in adults. Hepatitis D prevention can also be expected with the immunization provided by PreHevbri, as hepatitis D (caused by the delta agent) does not develop in the absence of infection with the virus hepatitis B. The use of PreHevbri should be in accordance with official recommendations. PreHevbri contains the complete antigenic composition of hepatitis B virus surface antigen, including HBV S, pre-S2 and pre-S1 surface antigens, and is the only HBV vaccine with 3 antigens which is authorized for adults in the European Union (EU) and in the countries of the European Economic Area (EEA): Iceland, Liechtenstein and Norway.
“We are very pleased to be able to announce the approval of PreHevbri in Europe, signaling our second major approval for this differentiated HBV vaccine in five months, following US FDA approval in late November last year,” said said Jeff Baxter, president and CEO of VBI. “Hepatitis B is a persistent, highly infectious and under-reported public health problem in Europe and we believe that PreHevbri can become a significant new tool for healthcare providers doing their best to combat it. We are committed to being part of this fight and we are working hard to make PreHevbri available in different European countries as soon as possible”.
The European Commission’s centralized marketing authorization is valid in all EU member states as well as in the countries of the European Economic Area (EEA) (Iceland, Liechtenstein and Norway). VBI plans to market PreHevbri in certain European countries at the end of 2022.
This authorization follows a favorable opinion issued in February 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, based on the positive results of two pivotal Phase 3 clinical studies, randomized, double-blind and controlled, PROTECT and CONSTANT. Data from these studies were published in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021, respectively. Both studies compared PreHevbri to Engerix-B, a single antigen HBV vaccine . Results from the PROTECT study showed that PreHevbri achieved higher seroprotection rates in all subjects aged 18 and over (91.4% vs. 76.5%), particularly in adults aged 45 and over (89.4% versus 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common side effects across all age groups were pain and tenderness at the injection site, myalgia and fatigue, all of which usually resolve without intervention within 1-2 days.
VBI continues to support the Medicines and Healthcare products Regulatory Agency (MHRA) review in the UK as part of the EC ECDRP procedure, which was initiated after receiving the positive opinion from the CHMP in February.
About Hepatitis B
Hepatitis B is among the world’s most significant infectious disease threats, with more than 290 million people infected worldwide. HBV infection is the leading cause of liver disease and is very difficult to cure with current treatments, with many patients subsequently developing liver cancer. An estimated 900,000 people die each year from complications of chronic HBV, such as hepatic decompensation, cirrhosis and hepatocellular carcinoma.
About PreHevbri™
VBI’s Hepatitis B Vaccine is the only 3-antigen hepatitis B vaccine, consisting of the three surface antigens of the hepatitis B virus: S, pre-S1 and pre-S2. It is approved for use in the European Union/European Economic Area, USA and Israel. The brand names of this vaccine are: PreHevbri™ (EU/EEA), PreHevbrio™ (US) and Sci-B-Vac® (Israel).
The Summary of Product Characteristics for PreHevbri is available on the European Medicines Agency (EMA) website at www.ema.europa.eu.
Please visit www.PreHevbrio.com for important U.S. safety information of PreHevbrio™ [Vaccin contre l’hépatite B (recombinant)]or please see the US site for complete prescribing information.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is an immunology-focused biopharmaceutical company researching potent disease prevention and treatment. Through its innovative Virus-Like Particle (“VLP”) approach, including its proprietary enveloped VLP (“ePPV”) technology platform, VBI is developing candidate vaccines that mimic the natural occurrence of viruses, designed to elicit the innate potency of human immune system. VBI is committed to targeting and defeating important infectious diseases, including hepatitis B, coronaviruses and cytomegalovirus (CMV), as well as aggressive cancers, including glioblastoma (GBM). VBI’s corporate headquarters are located in Cambridge, Massachusetts. The company has research facilities in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, please visit www.vbivaccines.com.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release, which are forward-looking in nature and do not constitute statements of historical facts, are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and constitute forward-looking information. within the meaning of Canadian securities laws (generally, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that could materially affect the results of the Company’s operations. These forward-looking statements are based on management’s beliefs as well as assumptions made by management and information currently available to it. Actual results may differ materially from those contemplated in the forward-looking statements due to certain factors, including, but not limited to, the impact of economic, industry, or general political conditions in the United States or globally; the impact of the current COVID-19 pandemic on our clinical studies, manufacturing, business plan and the global economy; the ability to successfully manufacture and market PreHevbrio or PreHevbri; the ability to determine the efficacy or safety of potential products during preclinical or clinical trials; the ability to create or maintain collaborations in connection with the development of pipeline candidates and the commercialization of PreHevbrio or PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to commercialize potential products; the ability to obtain future financing for products in development and working capital and to obtain such financing on commercially reasonable terms; the Company’s 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 obtain and enforce the Company’s rights to its products. A discussion of these and other factors, including risks and uncertainties affecting the Company, is set forth in the Company’s filings with the SEC and Canadian securities regulators, including its annual report. on Form 10-K filed with the SEC on March 7, 2022 and filed with the Canadian securities regulatory authorities at sedar.com on March 7, 2022, which may be supplemented or amended by the quarterly reports on the Company Form 10-Q. In view of these risks, uncertainties and factors, the reader is cautioned not to place undue reliance on these forward-looking statements, which are qualified in their entirety by this cautionary statement. All of these forward-looking statements are based on our current expectations, and we do not undertake to update or revise these forward-looking statements for any reason, except as required by law.
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