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CTL019 MAA submission to the EMA
CTL019 MAA submission to the EMA.
About this update from Oxford Biomedica Plc
[{"type":"text","content":"\n \nRNS Number : 6267V Oxford Biomedica PLC 06 November 2017 \n\n \n \n \n \n \n \nOxford BioMedica notes the CTL019 MAA submission to the EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL\n \nOxford, UK - 6 November 2017: Oxford BioMedica plc (\"Oxford BioMedica\" or \"the Group\") (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.\n \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.\n \n \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\nConsilium Strategic Communications\nMary-Jane Elliott/Matthew Neal/Philippa Gardner/Laura Thornton/Rosie Phillips\n \n\n\nTel: +44 (0)20 3709 5700\n\n\n\n\n \nNotes for editors\n \nAbout Oxford BioMedica\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 subsidiaries (the \"Group\") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo...