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.