Under the terms of the deal announced on Monday, Samsung has entered a ten year agreement to manufacture the human monoclonal antibody drug at its Songdo Incheon plant in South Korea.
“In Samsung Biologics we believe we have found a very strong partner,” BMS spokesperson Laura Hortas told Biopharma-Reporter.com.
Furthermore, she added, the Korean firm “will be focused on rapid and precise technology transfer” which was set to begin earlier this month, with production prepped to commence following regulatory approvals.
Financial terms of the agreement have not been disclosed.
Yervoy and Manufacturing Strategy
Yervoy was approved in the US March 2011 and is currently available in 41 countries. The drug is designed to treat late-stage melanoma by binding the cytotoxic T-lymphocyte antigen-4, which is a negative regulator of T-cell activation.
For the US, the drug is manufactured at BMS’s own facility in Syracuse, New York and, according to Hortas, will continue to be produced there.
Earlier this year, BMS announced a $250m (€190m) expansion of its Devens, Massachusetts large-scale, bulk production facility as part of a strategy to align the firm’s biologics development and manufacturing capabilities.
Though Devens is primarily intended to support rheumatoid arthritis biopharmaceutical Orencia, spokesperson John Patella told our sister publication in-Pharmatechnologist.com at the time “what future products may be manufactured there is unknown,” adding BMS’s five approved biologics – Nulojix, Yervoy, Orencia, Erbitux and Recothrom – were the foundation to future company growth.
The decision to use Samsung Biologics to manufacture Yervoy outside the US was not an indication of a move to outsourcing. Hortas said:
“Our manufacturing strategy for all of our products includes analysis of both capital investment in our own plants and contract manufacturing. Our decision making is ultimately driven by our mission to serve the needs of our patients.”