Approval underscores CSL and Arcturus
Therapeutics' commitment to delivering disruptive technologies to
combat COVID-19 and other respiratory viral diseases to protect
public health
- KOSTAIVE®, the world's first self-amplifying mRNA
(sa-mRNA) COVID-19 vaccine, was approved for adults
18 years of age and older in November
2023
- The updated sa-mRNA COVID-19 vaccine is tailored to protect
against the JN.1 lineage of Omicron subvariants
- Meiji Seika Pharma, CSL's exclusive partner in
Japan, will begin vaccine
distribution in time for the October COVID-19 vaccination
campaign
- CSL and Arcturus Therapeutics' partnership delivers on the
promise to advance innovative vaccine technology for viral
respiratory diseases
KING OF
PRUSSIA, Pa. and SAN
DIEGO, Sept. 13, 2024 /PRNewswire/ -- Global
biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and sa-mRNA pioneer
Arcturus Therapeutics today announced
that Japan's Ministry of Health, Labor and Welfare
(MHLWs) granted approval and authorization for their updated
self-amplifying mRNA (sa-mRNA) COVID-19 vaccine,
KOSTAIVE®. The updated vaccine is targeted to protect
against the JN.1 lineage of Omicron subvariants for adults 18 years
of age and older.
CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin
distributing the updated vaccine in time for the October COVID-19
vaccination campaign, marking the world's first commercially
available sa-mRNA COVID-19 vaccine for adults 18 and older.
In May 2024, a Japanese health
ministry panel recommended that COVID-19 vaccines be updated to
target the JN.1 lineage of Omicron subvariants for the 2024/2025
national immunization program. This aligns with recent
recommendations from the World Health Organization.
"We are pleased to receive the updated approval from
Japan's Ministry of Health, Labor
and Welfare, and remain on track to distribute KOSTAIVE®
in time for the October COVID-19 vaccination campaign,"
said Emmanuelle Lecomte-Brisset, Senior Vice President and
Head of Global Regulatory Affairs, CSL. "We look forward to
introducing KOSTAIVE® in Japan as a safe, tolerable and more durable
option in protecting against COVID-19."
"We believe KOSTAIVE® has the potential to
change the paradigm for COVID-19 vaccines in Japan," said Jonathan
Edelman, M.D., Senior Vice President, Vaccines Innovation
Unit, CSL. "Today's approval further demonstrates CSL's
promise to pursue, develop and deliver new innovative treatment
options to protect public health."
The approval is based on clinical evidence supporting the safety
and effectiveness of CSL and Arcturus Therapeutics' sa-mRNA
COVID-19 vaccine, including published data demonstrating superior
immunogenicity to Omicron BA 4/5 compared to a conventional mRNA
COVID-19 vaccine booster and follow-up data demonstrating duration
of immunity lasting up to one year.
"We are pleased that our sa-mRNA technology will be available to
vaccinate people in Japan against
COVID-19, which remains an ongoing risk to public health around the
world," said Joseph Payne, Chief Executive Officer of Arcturus
Therapeutics. "We look forward to continuing to work with CSL and
regulators to explore the development of KOSTAIVE® in
additional countries."
About sa-mRNA
mRNA vaccines help protect against
infectious diseases by providing a blueprint for cells in the body
to make a protein to help our immune systems recognize and fight
the disease. Unlike conventional mRNA vaccines, self-amplifying
mRNA vaccines instruct the body to make more mRNA and protein to
boost the immune response.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global
biotechnology company with a dynamic portfolio of lifesaving
medicines, including those that treat haemophilia and immune
deficiencies, vaccines to prevent influenza, and therapies in iron
deficiency and nephrology. Since our start in 1916, we have been
driven by our promise to save lives using the latest technologies.
Today, CSL – including our three businesses: CSL Behring, CSL
Seqirus and CSL Vifor – provides lifesaving products to patients in
more than 100 countries and employs 32,000 people. Our unique
combination of commercial strength, R&D focus and operational
excellence enables us to identify, develop and deliver innovations
so our patients can live life to the fullest. For inspiring stories
about the promise of biotechnology,
visit CSLBehring.com/Vita and follow us
on Twitter.com/CSL. For more information about CSL,
visit www.CSL.com.
About Arcturus
Founded in 2013 and based in
San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA
medicines and vaccines company with enabling technologies: (i)
LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology
(sa-mRNA) and (iii) mRNA drug substance along with drug product
manufacturing expertise. Arcturus developed
KOSTAIVE®, the first self-amplifying messenger
RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus
has an ongoing global collaboration for innovative mRNA vaccines
with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of
mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA
therapeutic candidates to potentially treat ornithine
transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along
with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19)
and influenza. Arcturus' versatile RNA therapeutics platforms can
be applied toward multiple types of nucleic acid medicines
including messenger RNA, small interfering RNA, circular RNA,
antisense RNA, self-amplifying RNA, DNA, and gene editing
therapeutics. Arcturus' technologies are covered by its extensive
patent portfolio (over 400 patents and patent applications in the
U.S., Europe, Japan, China,
and other countries). For more information, visit
www.ArcturusRx.com. In addition, please connect with us on
Twitter and LinkedIn.
About Meiji Seika Pharma Co., Ltd.
Meiji Seika Pharma, since it launched penicillin in 1946, has been
providing efficacious and high-quality pharmaceutical products such
as therapeutics and vaccines for infectious diseases, therapeutics
for central nervous system diseases as well as generic drugs in
response to various medical needs. As a leading company in the
field of infectious diseases, we are strengthening our platform for
infection control and prevention with vaccines and antimicrobial
agents.
Forward-Looking Statements
This press release contains
forward-looking statements that involve substantial risks and
uncertainties for purposes of the safe harbor provided by the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact included in this press
release, are forward-looking statements, including those regarding
strategy, future operations, the planned launch of
KOSTAIVE® in Japan, the distribution of the updated vaccine
by Meiji Seika Pharma and timing thereof, the timing and likelihood
of availability of doses of the updated vaccine in Japan, the continued demonstration of
KOSTAIVE® as a safe, tolerable and more durable
option against COVID-19, that preclinical or clinical data will be
predictive of future clinical results, and the impact of general
business and economic conditions. Arcturus may not actually achieve
the plans, carry out the intentions or meet the expectations or
projections disclosed in any forward-looking statements such as the
foregoing and you should not place undue reliance on such
forward-looking statements. These statements are only current
predictions or expectations, and are subject to known and unknown
risks, uncertainties, and other factors that may cause our or our
industry's actual results, levels of activity, performance or
achievements to be materially different from those anticipated by
the forward-looking statements, including those discussed under the
heading "Risk Factors" in Arcturus' most recent Annual Report on
Form 10-K, and in subsequent filings with, or submissions to, the
SEC, which are available on the SEC's website at www.sec.gov.
Except as otherwise required by law, Arcturus disclaims any
intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Media Contacts:
CSL Media Contacts
Sue Thorn
Mobile: 617 799 3151
Email: sue.thorn@cslbehring.com
Australia:
Jimmy Baker
Jimmy.Baker@csl.com.au
+61 450 909 211
Asia
Pacific:
Hamish
Walsh
+61 422 424 338
hamish.walsh@seqirus.com
Arcturus Media Contact:
Neda
Safarzadeh
VP, Head of IR/PR/Marketing
IR@arcturusrx.com
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SOURCE CSL