OXB notes FDA Advisory Committee to review CTL019

RNS Number : 3495H

Oxford Biomedica PLC

07 June 2017

 

Oxford BioMedica notes FDA Advisory Committee to review CTL019

London, UK - 7 June 2017: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, notes that the US Food and Drug Administration (FDA) has scheduled an Oncologic Drugs Advisory Committee meeting on 12 July 2017 to review the CTL019 (tisagenlecleucel-T) Biologics License Application (BLA) filing in relapsed and refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).

Novartis announced in March 2017 that the FDA accepted CTL019 for review and granted priority review status.

Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.

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For further information, please contact:
Oxford BioMedica plc: John Dawson, Chief Executive Officer Tim Watts, Chief Financial Officer	Tel: [phone]
Consilium Strategic Communications Mary-Jane Elliott/Matthew Neal/Chris Welsh/Laura Thornton	Tel: [phone]

Notes for editors

About Oxford BioMedica

Oxford 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 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, Orchard Therapeutics 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.

About FDA Advisory Committee meetings

FDA Advisory Committees consist of a panel of independent, external experts. The FDA convenes Advisory Committees to provide advice on scientific, technical and policy matters related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. The FDA is not obligated to follow the advice of the committee.

 

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