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Meiji Seika Pharma Announces Investment in ARCALIS, Inc.

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Meiji Seika Pharma announced its investment in ARCALIS, a joint venture between Axcelead and Arcturus Therapeutics focused on mRNA pharmaceuticals and vaccines development. ARCALIS aims to establish comprehensive domestic production of mRNA vaccines in Japan. The collaboration combines ARCALIS' mRNA technology with Meiji's manufacturing expertise to improve vaccine supply in Japan. Meiji plans to supply the domestically produced KOSTAIVE® sa-mRNA vaccine in December 2024, using active ingredients from ARCALIS. This initiative aligns with Japan's strategy to strengthen vaccine development and production systems, ensuring timely delivery of vaccines when needed.

Meiji Seika Pharma ha annunciato il suo investimento in ARCALIS, una joint venture tra Axcelead e Arcturus Therapeutics focalizzata sullo sviluppo di prodotti farmaceutici e vaccini mRNA. ARCALIS ha l'obiettivo di stabilire una produzione nazionale completa di vaccini mRNA in Giappone. La collaborazione combina la tecnologia mRNA di ARCALIS con l'expertise manifatturiera di Meiji per migliorare l'approvvigionamento di vaccini in Giappone. Meiji prevede di fornire il vaccino sa-mRNA KOSTAIVE® prodotto a livello nazionale a dicembre 2024, utilizzando principi attivi di ARCALIS. Questa iniziativa si allinea con la strategia del Giappone di rafforzare i sistemi di sviluppo e produzione di vaccini, assicurando una consegna tempestiva dei vaccini quando necessario.

Meiji Seika Pharma anunció su inversión en ARCALIS, una empresa conjunta entre Axcelead y Arcturus Therapeutics enfocada en el desarrollo de productos farmacéuticos y vacunas de mRNA. ARCALIS tiene como objetivo establecer una producción nacional integral de vacunas de mRNA en Japón. La colaboración combina la tecnología de mRNA de ARCALIS con la experiencia en fabricación de Meiji para mejorar el suministro de vacunas en Japón. Meiji planea suministrar la vacuna sa-mRNA KOSTAIVE® producida localmente en diciembre de 2024, utilizando ingredientes activos de ARCALIS. Esta iniciativa se alinea con la estrategia de Japón para fortalecer los sistemas de desarrollo y producción de vacunas, asegurando una entrega oportuna de vacunas cuando sea necesario.

메이지 세이카 제약은 mRNA 의약품 및 백신 개발에 중점을 둔 Axcelead와 Arcturus Therapeutics의 합작 투자 ARCALIS에 대한 투자를 발표했습니다. ARCALIS는 일본에서 mRNA 백신의 종합적인 국내 생산을 확립하는 것을 목표로 하고 있습니다. 이 협력은 메이지의 제조 전문성과 ARCALIS의 mRNA 기술을 결합하여 일본의 백신 공급을 개선하는 데 초점을 맞추고 있습니다. 메이지는 ARCALIS의 활성 성분을 사용하여 2024년 12월에 국내에서 생산된 KOSTAIVE® sa-mRNA 백신을 공급할 계획입니다. 이 이니셔티브는 필요한 시기에 백신의 적시 공급을 보장하기 위해 일본의 백신 개발 및 생산 시스템 강화 전략과 일치합니다.

Meiji Seika Pharma a annoncé son investissement dans ARCALIS, une coentreprise entre Axcelead et Arcturus Therapeutics axée sur le développement de produits pharmaceutiques et de vaccins à base d'ARNm. ARCALIS vise à établir une production nationale complète de vaccins ARNm au Japon. La collaboration combine la technologie ARNm d'ARCALIS avec l'expertise de fabrication de Meiji afin d'améliorer l'approvisionnement en vaccins au Japon. Meiji prévoit de fournir le vaccin sa-ARNm KOSTAIVE® produit localement en décembre 2024, en utilisant des ingrédients actifs d'ARCALIS. Cette initiative s'inscrit dans la stratégie du Japon visant à renforcer les systèmes de développement et de production de vaccins, garantissant une livraison rapide des vaccins lorsque cela est nécessaire.

Meiji Seika Pharma hat seine Investition in ARCALIS bekannt gegeben, ein Joint Venture zwischen Axcelead und Arcturus Therapeutics, das sich auf die Entwicklung von mRNA-Arzneimitteln und -Impfstoffen konzentriert. ARCALIS hat das Ziel, eine umfassende nationale Produktion von mRNA-Impfstoffen in Japan zu etablieren. Die Zusammenarbeit kombiniert die mRNA-Technologie von ARCALIS mit der Fertigungskompetenz von Meiji, um die Impfstoffversorgung in Japan zu verbessern. Meiji plant, den national hergestellten sa-mRNA-Impfstoff KOSTAIVE® im Dezember 2024 zu liefern, indem aktive Inhaltsstoffe von ARCALIS verwendet werden. Diese Initiative steht im Einklang mit Japans Strategie zur Stärkung der Impfstoffentwicklungs- und -produktionssysteme, um eine rechtzeitige Lieferung der Impfstoffe zu gewährleisten, wenn sie benötigt werden.

Positive
  • Strategic investment strengthens domestic mRNA vaccine production capabilities in Japan
  • Planned launch of KOSTAIVE® vaccine in December 2024
  • Integration of ARCALIS' mRNA technology with Meiji's manufacturing infrastructure
Negative
  • None.

Insights

This strategic investment by Meiji Seika Pharma in ARCALIS represents a significant development in Japan's mRNA vaccine manufacturing capabilities. The partnership combines ARCALIS's mRNA expertise with Meiji's established pharmaceutical infrastructure, addressing a critical gap in Japan's domestic vaccine production capacity.

The planned December 2024 launch of KOSTAIVE®, a domestically produced sa-mRNA vaccine, marks a pivotal milestone. This timing aligns with Japan's national strategy to strengthen vaccine independence, learned from COVID-19 pandemic challenges. The vertical integration of manufacturing, from API production by ARCALIS to final formulation by Meiji's group company, creates a robust supply chain.

For Arcturus Therapeutics (ARCT), this development strengthens its position in the Japanese market through its joint venture ARCALIS, potentially leading to increased revenue streams through technology transfer and manufacturing contracts. The collaboration also provides a blueprint for similar partnerships in other markets seeking domestic mRNA vaccine production capabilities.

TOKYO--(BUSINESS WIRE)-- 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/)

Meiji Seika Pharma

Public Relations

Sayoko Taga

pr-pharma@meiji.com

Axcelead, Inc. & ARCALIS, Inc.

Public Relations & Investor Relations

Mitsuo Oguri

mitsuo.oguri@axcelead.com

Arcturus Therapeutics

Public Relations & Investor Relations

Neda Safarzadeh

VP, Head of IR/PR/Marketing

(858) 900-2682

IR@ArcturusRx.com

Source: Meiji Seika Pharma Co., Ltd. and ARCALIS, Inc.

FAQ

When will Meiji Seika Pharma launch the KOSTAIVE® vaccine in Japan?

Meiji Seika Pharma plans to supply the domestically produced KOSTAIVE® sa-mRNA vaccine in December 2024, pending regulatory approval for the additional domestic manufacturing sites.

What is the purpose of Meiji Seika Pharma's investment in ARCALIS?

The investment aims to strengthen domestic mRNA vaccine production in Japan and improve vaccine supply capabilities through combining ARCALIS' mRNA technology with Meiji's manufacturing expertise.

Who are the joint venture partners in ARCALIS?

ARCALIS is a joint venture between Axcelead, Inc., which manages pharmaceutical and healthcare platform companies, and Arcturus Therapeutics, Inc., a commercial mRNA medicines and vaccines company.

Arcturus Therapeutics Holdings Inc.

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