Oxford Biomedica Regulatory News (OXB)

Oxford BioMedica Announces Successful MHRA Inspection and Approval to Manufacture at its new Facility in Yarnton, Oxford

- New manufacturing facility fully operational

- Creates extra capacity for wholly-owned pipeline, Novartis partnership and other new potential customers

Oxford, UK - 13 January 2016: Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE: OXB), a leading gene and cell therapy group, today announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at the Group's recently established and commissioned specialist biomanufacturing facility in Yarnton, Oxford, UK. 

The MHRA conducted a site-specific inspection in November 2015 to evaluate whether the Group's existing manufacturing processes and quality management systems had been effectively extended and implemented at the new Yarnton facility and remained in accordance with EU Good Manufacturing Practice (GMP) standards. MHRA has now confirmed that Oxford BioMedica's operations at Yarnton are in compliance with the principles and guidelines of GMP. Consequently, the facility at Yarnton is now fully-operational and authorised to perform GMP manufacturing activities. The successful delivery and licensing of the Yarnton facility provides the Group with a second fully independent GMP manufacturing site, strengthening the robustness of the Group's biologics supply chain, adding dual sourcing capability and doubling capacity. This additional capacity will support Oxford BioMedica's own proprietary programmes in development as well as consolidating key current and potential new strategic relationships such as the well-established CAR-T focussed partnership with Novartis for CTL-019.

Purposely designed around the Group's current and future state LentiVector® based platform processes, the 560m2/6,028ft2 of additional clean room space at Yarnton's state-of-the-art facility bolsters the Group's manufacturing capabilities, and increases total operational capacity across both sites to 950m2/10,226ft2. Further capacity expansion at the Group's existing Harrow House facility (also based in Oxford) is scheduled for completion in the first half of 2016 and will provide a third independent suite designed to house Oxford BioMedica's next generation of serum free, suspension cell line based processes. The continued investment in the Group's specialist biomanufacturing facilities and capabilities will help Oxford BioMedica address the industry's challenges of bridging clinical and commercial supply, one of the main hurdles associated with the rapid progression of gene and cell therapies through Phase II and Phase III clinical trials, and then ultimately to market. Importantly, it also provides the opportunity for Oxford BioMedica to maintain its world-leading position as the LentiVector® platform supplier of choice for its current and future partners.

John Dawson, Chief Executive Officer of Oxford BioMedica, said:

"We are world leaders in the development of lentiviral vector-based products and the successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica. This investment brings significant potential not only to support our own current and future pipeline of gene and cell therapy products in development but also to support our key collaboration with Novartis. Our IP, know-how, manufacturing operations and capacity now position Oxford BioMedica very strongly for securing further new partnerships and alliances."

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Notes for editors

About Oxford BioMedica®

Oxford BioMedica plc (LSE: OXB) is a leading gene and cell therapy Group with an unrivalled portfolio of gene therapy products in development and a platform of exclusive and pioneering technologies with which it designs, develops and manufactures unique gene-based medicines for some of world's largest pharmaceutical companies. Leveraging its proprietary LentiVector® IP and gene delivery system technology platform and unique tumour antigen (5T4), Oxford BioMedica is advancing its pipeline of six gene therapy products addressing diseases for which there are currently no treatments or that are inadequately treated today, including ocular and central nervous system disorders. OXB Solutions, the Group's industry-leading manufacturing and development business, provides services to collaborators and partners working in gene and cell therapy, including Novartis and Immune Design Corp. In addition, the Group has licenced products and IP to Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutions and ImaginAb. Further information is available at www.oxfordbiomedica.co.uk