Oxford Biomedica PLC BLA filing for CTL019 (9833A)
March 30 2017 - 2:02AM
UK Regulatory
TIDMOXB
RNS Number : 9833A
Oxford Biomedica PLC
30 March 2017
Oxford BioMedica notes acceptance by FDA of a Biologics License
Application (BLA) filing for CTL019
Oxford, UK - 30 March 2017: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, is pleased to note the announcement by Novartis that
the US Food and Drug Administration (FDA) has accepted its
Biologics License Application (BLA) filing and granted priority
review for CTL019 (tisagenlecleucel-T), an investigational chimeric
antigen receptor T cell (CAR-T) therapy, in relapsed and refractory
(r/r) pediatric and young adult patients with B-cell acute
lymphoblastic leukemia (ALL). The priority review designation is
expected to shorten the anticipated review time by the FDA.
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.
John Dawson, Chief Executive Officer of Oxford BioMedica,
commented: "The news that the FDA has accepted the BLA for CTL019
and granted it priority review is an important development for
Oxford BioMedica. We continue to work closely with Novartis in
delivering the lentiviral vector expressing CTL019, a product
described earlier this year by Novartis as having "blockbuster"
potential."
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
John Dawson, Chief Executive Officer
Tim Watts, Chief Financial Officer
Financial PR Enquiries: Tel: +44 (0)20 3709 5700
Mary-Jane Elliott / Matthew Neal / Chris Welsh / Laura
Thornton
Consilium Strategic Communications
Jefferies (Corporate Broker): Tel: +44 (0)20 7029 8000
Gil Bar-Nahum
Simon Hardy
Lee Morton
Max Jones
Nicholas Moore
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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