VBI Vaccines Announces Health Canada Approval for PreHevbrio™ for the Prevention of Hepatitis B in Adults
December 08 2022 - 08:00AM
Business Wire
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 Health Canada has
approved PreHevbrio™ [3-antigen Hepatitis B Vaccine (Recombinant)]
for active immunization against infection caused by all known
subtypes of hepatitis B (HBV) virus in adults 18 years of age and
older. It can be expected that hepatitis D will also be prevented
by immunization with PreHevbrio as hepatitis D (caused by the delta
agent) does not occur in the absence of hepatitis B infection.
“We are excited to announce Health Canada’s approval, a fourth
regulatory approval for this vaccine, and an achievement that is
another meaningful step in our effort to provide broad access to
our 3-antigen hepatitis B vaccine,” said Jeff Baxter, VBI’s
President and CEO. “As we’ve said many times, we believe PreHevbrio
has the potential to be a meaningful and differentiated tool that
can help healthcare providers make a difference in the fight to
eradicate hepatitis B, and we look forward to supporting public
health initiatives in Canada to facilitate this.”
The approval was based on clinical data in the new drug
submission (NDS), which highlighted the positive results from two
pivotal, randomized, double-blind, controlled Phase 3 clinical
studies, PROTECT and CONSTANT. Data from these studies were
published, respectively, in The Lancet Infectious Diseases in May
2021 and The Journal of the American Medical Association Network
Open in October 2021. Both studies compared PreHevbrio to
Engerix-B, a single-antigen HBV vaccine. Results from the PROTECT
study showed that PreHevbrio elicited higher rates of
seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including
in adults age 45+ (89.4% vs. 73.1%). The PROTECT study results also
showed that PreHevbrio induced higher rates of seroprotection in
subjects with diabetes (83.3% vs. 58.3%) as well as in subjects
with body mass index (BMI) over 30 (89.22% vs. 68.11%). The
integrated safety analysis of both studies demonstrated good
tolerability with no unexpected reactogenicity. The most common
adverse events in all age groups were injection site pain and
tenderness, myalgia, and fatigue, all which generally resolved
without intervention in 1-2 days.
About PreHevbrio™
VBI’s hepatitis B vaccine 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 Canada, the United States, European Union/European Economic
Area, United Kingdom, and Israel. The brand names for this vaccine
are: PreHevbrio™ (US, Canada), PreHevbri™ (EU/EEA, UK), and
Sci-B-Vac® (Israel).
The full product monograph including patient medication
information for PreHevbrio in Canada will be made available on the
Government of Canada's Drug Product Database.
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 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 ongoing 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 7, 2022, and filed with the Canadian security
authorities at sedar.com on March 7, 2022, 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/20221208005177/en/
VBI Nicole Anderson Director, Corporate Communications
& IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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