Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi; hereinafter referred to as "Meiji Seika Pharma") today announced its investment in ARCALIS, Inc. (Headquarters: Minami-soma City, Fukushima Prefecture; President: Satoshi Takamatsu; hereinafter referred to as "ARCALIS").

ARCALIS is a joint venture between Axcelead, Inc., which manages a group of world-class pharmaceutical and healthcare platform companies, and Arcturus Therapeutics, Inc. a commercial mRNA medicines and vaccines company. ARCALIS is engaged in the development of mRNA pharmaceuticals and vaccines, as well as contract development and manufacturing organization (CDMO) services. The company plans to establish a comprehensive system for the domestic production of mRNA vaccines, ranging from the development of manufacturing technologies to the production of both active pharmaceutical ingredients and formulations.

In response to the lessons learned from the delays experienced in the development of COVID-19 vaccines during the pandemic, ARCALIS and Meiji Seika Pharma are committed to advancing the development, production, and supply of mRNA vaccines in line with the "Strategy for Strengthening Vaccine Development and Production Systems" adopted by the Japanese government. This strategy is designed to ensure that the necessary quantities of vaccines are delivered to the population in a timely manner when they are needed.

This investment will further strengthen the collaborative relationship between the two companies. The combination of ARCALIS' advanced technology and operations in mRNA pharmaceuticals and vaccines with Meiji Seika Pharma's expertise in manufacturing, post-marketing safety management and stable product supply is expected to significantly improve the supply of mRNA vaccines in Japan.

Meiji Seika Pharma plans to supply the domestically produced next-generation sa-mRNA vaccine (replicon) ‘KOSTAIVE® for Intramuscular Injection’ in December 2024. This vaccine will be formulated by a Meiji Seika Pharma Group company using the active pharmaceutical ingredient produced by ARCALIS. Supply will commence upon approval of the partial change in manufacturing and marketing authorization for the additional domestic manufacturing sites currently under application.

Meiji Seika Pharma is committed to the timely and reliable production and supply of essential vaccines to the public in response to potential future infectious diseases.

About Meiji Seika Pharma

Meiji Seika Pharma, since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products including therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases and generic drugs, to meet various medical needs.（https://www.meiji.com/global/pharmaceuticals/）

About ARCALIS

ARCALIS is an mRNA vaccines and therapeutics contract development and manufacturing organization (“CDMO”), jointly established by Axcelead, Inc. and Arcturus Therapeutics, Inc.. ARCALIS aims to develop the world’s first mRNA vaccines and therapeutics CDMO business that promises a stable supply of high-quality mRNA medicines to all customers, including Arcturus, other pharmaceutical companies, biotech companies, and academic institutes worldwide. (https://corp.arcalis.co.jp/en/)

About Axcelead

Axcelead is a healthcare platform company that owns Axcelead Drug Discovery Partners, Inc., Japan’s first drug discovery solution provider, and ARCALIS Inc., a CDMO company capable of integrated manufacturing of mRNA pharmaceuticals. (https://www.axcelead-hd.com/en-home/)

About Arcturus Therapeutics

Arcturus Therapeutics Holdings Inc. founded in 2013, is a commercial mRNA medicines and vaccines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases. (https://arcturusrx.com/)

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