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Oxford BioMedica plc. (3/30/17). "Press Release: Oxford BioMedica Notes Acceptance by FDA of a Biologics License Application (BLA) Filing for CTL019". Oxford.

Region Region United States (USA)
Organisations Organisation Oxford BioMedica plc (LSE: OXB)
  Group Oxford BioMedica (Group)
  Organisation 2 Novartis AG (NYSE: NVS)
  Group Novartis (Group)
Products Product LentiVector® technology
  Product 2 tisagenlecleucel-T (CTL019)
Index term Index term Novartis–Oxford BioMedica: lentiviral vector technology, 201703 supply existent OBM sole producer of lentiviral vector expressing CTL019
Persons Person Dawson, John (Oxford BioMedica 200810– CEO before Cephalon Europe)
  Person 2 Watts, Tim (Oxford BioMedica 2012–201709 CFO RETIRED 9/17)
     


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-


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.


For further information please contact:

Oxford BioMedica plc
John Dawson, Chief Executive Officer
Tim Watts, Chief Financial Officer
Tel: +44 (0)1865 783 000

Consilium Strategic Communications - Media Enquiries
Mary-Jane Elliott
Tel: +44 (0)20 7920 2345

   
Record changed: 2017-04-04

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