Benlysta is being jointly developed under a co-development and commercialisation agreement entered into, in 2006, by HGS and GlaxoSmithKline (GSK).
Belimumab is an investigational human monoclonal antibody drug that specifically recognises and inhibits the biological activity of B-lymphocyte stimulator, or BlyS.
GSK has submitted a marketing authorization application (MAA) to the European Medicines Agency, in June 2010, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, while HGS submitted a biologics license application (BLA) to the FDA seeking approval to market belimumab in the US.
Randy Maddux, vice president of manufacturing operations at HGS, said: “Our HGS manufacturing facility has capacity to supply Benlysta following approval, and for the first two or three years following launch.
“However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of commercial manufacturing organisations, we have selected Lonza.”
Stephan Kutzer, chief operating officer of custom manufacturing at Lonza, said: “We are enthusiastic about supporting the future production of Benlysta with our capabilities and expertise in biopharmaceutical manufacturing.”