Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI
Vaccines Inc. (Nasdaq: VBIV) (VBI) today announced a partnership in
select European markets for the marketing and distribution of
PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)], the only
3-antigen hepatitis B vaccine approved in Europe.
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Under the terms of the agreement, specialty vaccine company
Valneva will promote and distribute PreHevbri throughout select
European countries, which initially include the United Kingdom,
Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands.
Valneva and VBI expect PreHevbri to be available in these countries
in early 2023.
Thomas Lingelbach, President and CEO of Valneva, commented: “We
welcome this partnership with VBI which underlines Valneva’s
expertise in vaccine commercialization. Among the past years, we
have continued to develop our third-party vaccine marketing and
distribution activities further, notably with the signing of a
distribution agreement with Bavarian Nordic in 2020, and we are
extremely pleased to add VBI’s Hepatitis B vaccine to this
portfolio today. Our objective is to continue leveraging our
commercial infrastructure to combat as many infectious diseases as
we can.”
Jeff Baxter, President and CEO of VBI, commented: “This
partnership is a significant milestone for PreHevbri, enabling us
to hit the ground running in Europe. Valneva has substantial local
knowledge, experience, and relationships in each of these European
countries where we expect to launch, which will be of critical
value as we work, collectively, to provide broad access to this
differentiated 3-antigen HBV vaccine in Europe. Strategically, VBI
and Valneva are two companies aligned by a shared mission to reduce
the burden of infectious disease, and this new collaboration will
build upon that meaningful synergy.”
PreHevbri was approved by the European Commission (EC) and the
United Kingdom Medicines and Healthcare products Regulatory Agency
(MHRA) in the second quarter of 2022 for active immunization
against infection caused by all known subtypes of the hepatitis B
virus (HBV) in adults.
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, the United Kingdom, the United
States, and Israel. The brand names for this vaccine are:
PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac®
(Israel).
Full European Summary of Product Characteristics for PreHevbri
are available from the EMA website at www.ema.europa.eu.
Please visit www.PreHevbrio.com for U.S. Important Safety
Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or
please see U.S. Full Prescribing Information.
U.S. Indication
PreHevbrio is indicated for prevention of infection caused by
all known subtypes of hepatitis B virus. PreHevbrio is approved for
use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of
severe allergic reaction (e.g. anaphylaxis) after a previous dose
of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available
to manage possible anaphylactic reactions following administration
of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant
therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a
long incubation period, in individuals who have an unrecognized
hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44,
adults age 45-64, and adults age 65+ were pain and tenderness at
the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women who received PreHevbrio during pregnancy. Women
who receive PreHevbrio during pregnancy are encouraged to contact
1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at
1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or
www.vaers.hhs.gov.
Please see Full Prescribing Information.
About Valneva SE
Valneva is a specialty vaccine company focused on the
development and commercialization of prophylactic vaccines for
infectious diseases with significant unmet medical need. The
Company takes a highly specialized and targeted approach to vaccine
development and then applies its deep understanding of vaccine
science to develop prophylactic vaccines addressing these diseases.
Valneva has leveraged its expertise and capabilities both to
commercialize three vaccines and to rapidly advance a broad range
of vaccine candidates into and through the clinic, including
candidates against Lyme disease and the chikungunya virus.
Valneva Forward-Looking Statements
This press release contains certain forward-looking statements
relating to the business of Valneva, including with respect to the
progress, timing, results and completion of research, development
and clinical trials for product candidates, its manufacturing and
commercialization capabilities, and estimates for future
performance. In addition, even if the actual results or development
of Valneva are consistent with the forward-looking statements
contained in this press release, those results or developments of
Valneva may not be sustained in the future. In some cases, you can
identify forward-looking statements by words such as "could,"
"should," "may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
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/
VBI 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 ongoing 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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VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com Valneva Contact Laëtitia
Bachelot-Fontaine VP Global Communications & European Investor
Relations Phone: +33 (0)6 4516 7099 Email:
laetitia.bachelot-fontaine@valneva.com Joshua Drumm, Ph.D. VP
Global Investor Relations Phone: +1 917 815 4520 Email:
joshua.drumm@valneva.com
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