Date: 2014-01-07
Type of information: Licensing agreement
Compound: BOW015 (biosimilar version of Remicade® (infliximab))
Company: Epirus Switzerland (Switzerland) Ranbaxy (India)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Type agreement: licensing
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:
Details: • On January 7, 2014, Epirus Switzerland, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals, and Ranbaxy, a division of Daiichi Sankyo, have announced the signing of a licensing agreement for BOW015, a biosimilar infliximab, for the broad range of territories including India, selected South East Asian markets, North Africa and several other markets. Under the terms of the agreement Epirus and Ranbaxy will initially pursue the commercialization of BOW015, the Epirus biosimilar molecule to Remicade®, in India. Epirus recently announced successful Phase 3 data for BOW015 and, in November, filed for market approval.
Subsequent to launch in India, Ranbaxy will pursue registration and commercialization of BOW015 in other territories in South East Asia, North Africa and selected other markets. In exchange for the rights to BOW015 in the territories, Epirus will receive upfront, milestone, and royalty payments over the term of the agreement. Epirusplans to submit regulatory filings for BOW015 in targeted emerging markets over the next 12 months.
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