FUJIFILM Diosynth Biotechnologies Enters Into an Agreement with Argenx to Manufacture Efgartigimod, a monoclonal antibody (mAb) for the Treatment of Severe Autoimmune Diseases

HILLERØD, Denmark, Oct. 27, 2022 (GLOBE NEWSWIRE) — FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization for biologics, vaccines, and advanced therapies today announced an agreement with argenx to manufacture efgartigimod, a monoclonal antibody (mAb) fragment to target the neonatal Fc receptor (FcRn), in patients with severe autoimmune disease. Under the agreement, FUJIFILM Diosynth Biotechnologies will provide drug substance manufacturing of efgartigimod at its large-scale biomanufacturing facility in Hillerød, Denmark. Terms of the agreement were not disclosed.

Efgartigimod is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) – a chronic autoimmune neuromuscular disease that causes muscle weakness– who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies. Efgartigimod is also being evaluated for the treatment of patients with other severe autoimmune diseases known to be mediated by disease-causing immunoglobulin G autoantibodies and where a serious unmet medical need exists.

“We are delighted to partner with argenx and contribute with our expertise and technologies in bringing this important therapy to patients,” said Lars Petersen, chief operating officer, FUJIFILM Diosynth Biotechnologies, Denmark. “This collaboration underscores our employees’ commitment and ability to successfully onboard new programs and to provide a well-established and strong ecosystem to manufacture therapeutic antibodies for commercial use at a large-scale. We are all proud to support an effort to help patients with severe autoimmune diseases.”

“We are happy to partner with FUJIFILM Diosynth Biotechnologies to expand our large-scale manufacturing capacity for efgartigimod in our pursuit to bring this innovative treatment to patients in need around the world,” commented Filip Borgions, global head of technical operations, argenx.

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization partner to development and manufacture of biologics, vaccines and advanced therapies. The company operates a global network with major locations in the United States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. Mitsubishi Corporation is a 20% shareholder of FUJIFILM Diosynth Biotechnologies’ UK, Research Triangle Park, North Carolina, Watertown, Massachusetts and College Station, Texas sites. For more information, go to: www.fujifilmdiosynth.com.

About FUJIFILM Holdings Corporation

FUJIFILM Holdings Corporation, Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver Value from Innovation in our products and services in the business segments of healthcare, materials, business innovation, and imaging. Our relentless pursuit of innovation is focused on providing social value and enhancing the lives of people worldwide. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information about Fujifilm’s Sustainable Value Plan 2030, click here. For the year ended March 31, 2022, the company had global revenues of approximately 2.5 trillion yen (21 billion $USD at an exchange rate of 122 yen/dollar). For more information, please visit: www.fujifilmholdings.com.

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