Lonza enters into commercial manufacturing agreement for BENLYSTA
Deal could form the basis for a long-term, collaborative relationship with Human Genome Sciences
Human Genome Sciences (HGS) and Lonza have entered into an agreement for the future commercial supply of BENLYSTA (belimumab), which is currently under regulatory review in the US 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 commercialisation 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 organisations, we have selected Lonza 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 US FDA seeking approval to market belimumab in the US. No new drug for lupus has been approved by regulatory authorities for more than 50 years.
‘We are enthusiastic about supporting the future production of BENLYSTA with our cutting-edge capabilities and expertise in biopharmaceutical manufacturing,’ said Dr Stephan Kutzer, chief operating officer, Lonza Custom Manufacturing. ‘Working on such an important new drug for lupus patients will be very rewarding and the basis for a long-term, collaborative relationship with HGS.’
