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PharmaCell will become the European CMO for Dendreon for the commercial production of its cellular immunotherapy product Provenge.
PharmaCell has entered into an agreement with Dendreon to be the CMO for the European commercial production of its recently approved cellular immunotherapy product Provenge (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion.
In September 2013, the European Commission granted marketing authorization for Provenge in the European Union for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. In the United States, Provenge was approved in 2010 and is produced by Dendreon in its own manufacturing facilities.