VBI Vaccines Announces PreHevbri® is Now Available in the Netherlands and Belgium for the Prevention of Hepatitis B in Adults
July 19 2023 - 8:00AM
Business Wire
- PreHevbri® is the only approved 3-antigen hepatitis B vaccine
for adults in the Netherlands and Belgium
- Product to be launched via marketing and distribution partner,
Valneva
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced that PreHevbri®
[Hepatitis B vaccine (recombinant, adsorbed)] is now available in
the Netherlands and Belgium for active immunization against
infection caused by all known subtypes of the hepatitis B virus
(HBV) in adults. It can be expected that hepatitis D will also be
prevented by immunization with PreHevbri as hepatitis D (caused by
the delta agent) does not occur in the absence of hepatitis B
infection. As part of the marketing and distribution partnership
announced in September 2022, PreHevbri will be available in the
Netherlands and Belgium through Valneva’s existing commercial
infrastructure and distribution networks.
Jeff Baxter, President and CEO of VBI, commented: “We are
excited to announce the launch of PreHevbri in the Netherlands and
Belgium through our partnership with Valneva. Over the next several
months, we expect to continue to expand global access to PreHevbri
with additional market launches as we work to make an impact in the
fight against hepatitis B worldwide.”
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 900,000
people die each year from complications of chronic HBV such as
liver decompensation, cirrhosis, and hepatocellular carcinoma.
About PreHevbri® [Hepatitis B vaccine (recombinant,
adsorbed)]
PreHevbri is the only 3-antigen hepatitis B vaccine, comprised
of the three hepatitis B 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, United Kingdom, United States,
Canada, and Israel. The brand names for this vaccine are:
PreHevbri® (EU/EEA/UK), PreHevbrio® (US/Canada), and Sci-B-Vac®
(Israel).
Full European Summary of Product Characteristics for PreHevbri
is available from the EMA website at www.ema.europa.eu.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven
by immunology in the pursuit of powerful prevention and treatment
of disease. Through its innovative approach to virus-like particles
(“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform
technology, VBI develops vaccine candidates that mimic the natural
presentation of viruses, designed to elicit the innate power of the
human immune system. VBI is committed to targeting and overcoming
significant infectious diseases, including hepatitis B,
coronaviruses, and cytomegalovirus (CMV), as well as aggressive
cancers including glioblastoma (GBM). VBI is headquartered in
Cambridge, Massachusetts, with research operations in Ottawa,
Canada, and a research and manufacturing site in Rehovot,
Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking
Information
Certain 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, “forward-looking statements”). The
Company cautions that such forward-looking statements involve risks
and uncertainties that may materially affect the Company’s 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 COVID-19 pandemic and the continuing effects of the COVID-19
pandemic on our clinical studies, manufacturing, business plan, and
the global economy; the ability to successfully manufacture and
commercialize PreHevbrio/PreHevbri; 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 pipeline candidates and the
commercialization of PreHevbrio/PreHevbri; the ability to obtain
appropriate or necessary regulatory 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’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
secure and enforce legal rights related to the Company’s products.
A discussion of these and other factors, including risks and
uncertainties with respect to the Company, is set forth in the
Company’s filings with the SEC and the Canadian securities
authorities, including its Annual Report on Form 10-K filed with
the SEC on March 13, 2023, and filed with the Canadian security
authorities at sedar.com on March 13, 2023, as may be supplemented
or amended by the Company’s 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230719628465/en/
VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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