Oxford Biomedica PLC OXB notes FDA Advisory Committee to review CTL019
June 07 2017 - 2:01AM
RNS Non-Regulatory
TIDMOXB
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.
- Ends -
For further information, please
contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Tim Watts, Chief Financial Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Chris 3709 5700
Welsh/Laura Thornton
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(R) ), 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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