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
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240913667150/en/
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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