Date: 2013-10-23
Type of information: Production agreement
Compound: Provenge® (sipuleucel-T)
Company: PharmaCell (The Netherlands) Dendreon (USA)
Therapeutic area: Cancer - Oncology
Type agreement: manufacturing
production
Action mechanism: cell immunotherapy. Provenge® is a cellular immunotherapy designed to induce an immune response against prostate cancer cells. Provenge® uses immune cells which are extracted from the patient’s body. These cells are then mixed outside the patient’s body with a ‘fusion protein’, which is taken up by the cells. The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells. When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP.
Disease: prostate cancer
Details: * On October 23, 2013 , PharmaCell has announced that it has entered into an agreement with Dendreon to be the Contract Manufacturing Organization (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, the European Commission (EC) 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, Proveng®e was approved in 2010 and is produced by Dendreon in its own manufacturing facilities.
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