BLA filing for CTL019

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."

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For further information, please contact:

Oxford BioMedica plc:    Tel: [phone]

John Dawson, Chief Executive Officer
Tim Watts, Chief Financial Officer

Financial PR Enquiries:  Tel: [phone]

Mary-Jane Elliott / Matthew Neal / Chris Welsh / Laura Thornton
Consilium Strategic Communications

Jefferies (Corporate Broker): Tel: [phone]

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^®), 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.

 

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