FUJIFILM Diosynth Biotechnologies Expands Manufacturing Agreement with Argenx for Efgartigimod for the Treatment of Severe Autoimmune Diseases
 

HILLERØD, Denmark - FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization for biologics, vaccines, advanced therapies and oncolytic viruses, today announced an expansion of its manufacturing agreement with argenx to provide drug product and finished goods services for efgartigimod, a monoclonal antibody (mAb) fragment to target the neonatal Fc receptor (FcRn), in patients with severe autoimmune disease. This expands on the previously announced (October 2022) agreement for drug substance manufacturing at FUJIFILM Diosynth Biotechnologies’ 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 – a chronic autoimmune neuromuscular disease that causes muscle weakness. 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 support argenx with drug substance, drug product and finished goods services for their late-stage clinical trials for efgartigimod and getting this life-impacting therapeutic one step closer to the patients in need,” said Kenneth Bilenberg, executive vice president, Large-Scale Business Unit, FUJIFILM Diosynth Biotechnologies. “Expanding this partnership is the culmination of two years of successfully earning argenx’ trust – an essential ingredient in our approach to working with customers,” continued Bilenberg. “It is an excellent example of our commitment to manufacture vital medicines and to fulfill our role as true Partners for Life.”    

“This agreement represents another significant milestone for our site,” said Christian Houborg, site head and senior vice president FUJIFILM Diosynth Biotechnologies. “This partnership will propel our innovative drug product line allowing argenx to experience the full benefits of our end-to-end services from Hillerød,” continued Houborg. “Working together with transparency, shared goals and a commitment to mutual respect will enable both of our organizations to achieve collective success.”

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 Unites 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. 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, 2023, the company had global revenues of approximately 2.9 trillion yen (21 billion $USD at an exchange rate of 134 yen/dollar). For more information, please visit: www.fujifilmholdings.com.

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, globally in the U.S., Japan, Israel, the EU, the UK, China and Canada. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.