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Oxford BioMedica plc. (8/7/17). "Press Release: Oxford BioMedica Announces MHRA Licence For Commercial Supply". London.

Region Region United Kingdom (GB)
Organisations Organisation Oxford BioMedica plc (LSE: OXB)
  Group Oxford BioMedica (Group)
  Organisation 2 MHRA (GB)
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
Person Person Dawson, John (Oxford BioMedica 200810– CEO before Cephalon Europe)
     


Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today announces that it has been granted a Manufacturer/Importer License (MIA), from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”), to manufacture and distribute lentiviral vector material for commercial supply. This is in addition to the existing MIA (IMP) licence for Investigational Medicinal Products (IMPs) manufacture, which the Group has held for over 10 years.

Including significant know-how and proprietary analytical methods, Oxford BioMedica has established a world-leading platform for lentiviral vector bioprocessing at its state-of-the-art custom-built facilities in Oxford, UK, that allow full control over the entire lentiviral vector manufacturing process.

Oxford BioMedica recently signed an agreement with Novartis 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.

In addition to the Novartis agreement, Oxford BioMedica has bioprocessing and process development partnerships with Immune Design and Orchard Therapeutics.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented:
“Receiving regulatory approval for the manufacture of lentiviral vector material for commercial supply is another significant milestone for Oxford BioMedica. We look forward to working closely with our existing partners in lentiviral vector bioprocessing and process development, and believe that our expertise and technology will be of benefit to other companies working in gene and cell therapy.”

- 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/Matthew Neal/Philippa Gardner/Laura Thornton
Tel: +44 (0)20 3709 5700

   
Record changed: 2017-08-18

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