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19-07-2010: Human Genome Sciences, Inc. (HGS) and Lonza announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.
“Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, and for the first two or three years following launch,” said Randy J. Maddux, Vice President, Manufacturing Operations, HGS. “However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of highly qualified commercial manufacturing organizations, we have selected Lonza, a leader in biologics manufacturing with a global network of large-scale production sites. We are confident that Lonza is the right choice to fill this critically important role.”
In June 2010, GSK submitted a Marketing Authorization Application to the European Medicines Agency, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, and HGS submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States.
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