Full Press Release Details
Name of Company: Meiji Holdings Co., Ltd.
Name of Representative: Kazuo Kawamura, CEO, President
and Representative Director
Code Number: 2269, Prime Market, Tokyo Stock Exchange
Additional Application for Booster Dose of ARCT-154,
Self-Amplifying mRNA Vaccine against COVID-19,
Meiji Holdings Co., Ltd. Announces that its subsidiary,
Meiji Seika Pharma Co., Ltd., submitted an additional Application for a Booster Dose of ARCT-154 in adults in Japan. ARCT-154, a self-amplifying
mRNA vaccine candidate against COVID-19 that was developed by Arcturus Therapeutics Inc.*1, and on April 11, 2023 Meiji Seika
Pharma obtained exclusive rights to distribute ARCT-154 in Japan from CSL Seqirus.*2
ARCT-154 uses next-generation self-amplifying mRNA
technology which generates a strong immune response, a favorable tolerability profile and the potential for extended duration of protection
while using lower doses of mRNA compared to existing mRNA vaccines.
Meiji Seika Pharma submitted an additional Application
for a booster dose of ARCT-154 based on results of a Phase III clinical trial (jRCT2071220080) conducted in Japan involving subjects aged
18 years and older, who had received 3 complete doses of mRNA vaccine and the last dose received with COMIRNATY occurred
3 months and more prior to screening. The trial evaluated the geometric mean titers and seroconversion rates of neutralizing antibodies
against SARS-CoV-2(Wuhan strain) on day 29 after a booster shot of ARCT-154 or COMIRNATY , and the results met its primary
endpoint. No clinically significant concerns were identified in safety.
In the meantime, an NDA for primary immunization
of ARCT-154 was submitted on April 28, 2023. This is the first application for a next generation mRNA vaccine in a developed country.
Under the terms of an agreement with CSL Seqirus,
Meiji Seika Pharma will be responsible for obtaining regulatory approval, and for distribution, sales and marketing of ARCT-154 in Japan.
Meiji Seika Pharma is collaborating with ARCALIS,
Inc.*3 to establish integrated mRNA vaccine manufacturing capabilities from drug substance to drug product in Japan. ARCALIS
is building a manufacturing facility in Minami-soma City, Fukushima Prefecture.
Meiji Seika Pharma is working to supply ARCT-154
in Japan as soon as possible following approval. If approved, ARCT-154 will become a new vaccination option against COVID-19. The impact
on the consolidated financial results forecast for the fiscal year ending March 31, 2024, has not been determined at this time. We will
closely examine the situation and disclose the impact as soon as it is recognized.
English translation is prepared for the readers' convenience. When there are any discrepancies between the original Japanese version
and English translation version, the original Japanese version always prevails.