Oxford Biomedica PLC CTL019 MAA submission to the EMA (6267V)
November 06 2017 - 2:37AM
UK Regulatory
TIDMOXB
RNS Number : 6267V
Oxford Biomedica PLC
06 November 2017
Oxford 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
Oxford, 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.
Oxford 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.
- Ends -
For further information, please
contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Stuart Paynter, Chief Financial
Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Philippa 3709 5700
Gardner/Laura Thornton/Rosie Phillips
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 280 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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