Date: 2015-05-14
Type of information: Development agreement
Compound: BOW015 (biosimilar version of Remicade® (infliximab))
Company: Epirus Biopharmaceuticals (USA - MA) mAbxience (Switzerland)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement: development, distribution
Action mechanism: biosimilar/monoclonal antibody. BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. Epirus has completed a successful Phase 3 trial which met its predefined endpoint, demonstrating comparability of BOW015 to Remicade® as measured by ACR20 response in severe rheumatoid arthritis patients. The study also showed no meaningful differences between BOW015 and Remicade® with regard to safety or immunogenicity.
Disease: rheumatoid arthritis
Details: • On May 14, 2015, Epirus Biopharmaceuticals and mAbxience, a biopharmaceutical company specialized in research, development and manufacturing of biosimilars, entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade®), for Latin American markets, including Argentina, Chile, Ecuador, Paraguay, Uruguay and Venezuela. mAbxience is a wholly-owned subsidiary of CHEMO Group. Leveraging the CHEMO Group’s infrastructure, mAbxience will be responsible for regulatory submissions, using BOW015’s existing data package, and eventual commercialization in these select Latin American markets.
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