Press releases

FDA Advisory Committee Unanimously Recommends CTL019 (tisagenlecleucel) for Approval

London, UK - 13 July 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’s (FDA) Oncologic Drugs Advisory Committee voted unanimously 10 to 0 in favour of approval of Novartis investigational therapy CTL019 (tisagenlecleucel) for the treatment of relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).
Novartis announced in March that the FDA accepted its BLA filing and granted priority review for CTL019 in paediatric and young adult patients with B-cell ALL. The BLA review is ongoing and is under FDA priority review.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes CTL019. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products. Oxford BioMedica recently signed an agreement with Novartis 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.
John Dawson, Chief Executive Officer of Oxford BioMedica, commented: “The positive vote by 10 to 0 provides further support for CTL019, a novel immunocellular therapy, and we are proud to be a part of this important development. We continue to work closely with Novartis in delivering the lentiviral vector that encodes CTL019, a product the company described earlier this year as having “blockbuster” potential.”

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Notes to editors

About Oxford BioMedica®

Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy company 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®) through which the Group develops in vivo and ex-vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Sanofi, GSK, and Immune Design, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 250 people. Further information is available at www.oxfordbiomedica.co.uk.

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Oxford BioMedica plc

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