Business
CTL019 receives FDA approval
CTL019 receives FDA approval.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 3475P Oxford Biomedica PLC 30 August 2017 \n\n \n \n \n \n \n \nCTL019 receives FDA approval for paediatric, young adult r/r B-cell ALL \n \nLondon, UK - 30 August 2017: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, today notes that the US Food and Drug Administration (FDA) has approved Novartis' CAR-T cell therapy CTL019 (tisagenlecleucel, brand name KymriahTM) for the treatment of relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).\nOxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.\nJohn Dawson, Chief Executive Officer of Oxford BioMedica, commented: \"We are delighted that the FDA has now approved CTL019. This innovative immunocellular therapy will offer critically ill patients with an aggressive disease a new treatment option. Oxford BioMedica will supply the lentiviral vector encoding CTL019 and we look forward to continuing our collaboration with Novartis, both for commercial supply of CTL019, as well as bioprocessing and manufacturing for the clinical development of their other CAR-T products.\" \n- Ends -\n \n \n\n\n\n\nFor further information, please contact:\n\n\n \n\n\n\n\n \nOxford BioMedica plc:\nJohn Dawson, Chief Executive Officer\nStuart Paynter, Chief Financial Officer\n \n\n\n \nTel: +44 (0)1865 783 000\n\n\n\n\n \nConsilium Strategic Communications\nMary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton\n \n\n\n \n \nTel: +44 (0)20 3709 5700\n\n\n\n\n \nNotes for editors\n \n \nAbout Oxford BioMedica\n \nOxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsid...