Milestone in Trovax

Oxford Biomedica PLC 11 September 2007 For Immediate Release 11 SEPTEMBER 2007 OXFORD BIOMEDICA REACHES FIRST MILESTONE IN TROVAX(R) COLLABORATION WITH SANOFI-AVENTIS Oxford, UK - 11 September 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced that it has reached the first development milestone in its collaboration with sanofi-aventis for TroVax, the cancer immunotherapy, which triggers a payment of €9 million. The milestone relates to the successful enrolment of 350 patients in the Phase III TRIST study of TroVax in renal cancer. This represents half of the anticipated 700 patients to be enrolled into the trial. Oxford BioMedica and sanofi-aventis entered a global development and commercialisation agreement for TroVax in March 2007. Under the terms of this agreement, Oxford BioMedica received an initial payment of €29 million. This first development milestone of €9 million is part of a potential €19 million in near-term milestone payments linked to the Phase III TRIST study. The Company could receive a total of €518 million in initial and milestone payments if development and registration targets are met for certain defined indications. The agreement includes additional undisclosed regulatory milestone payments for other cancer types; undisclosed commercial milestones when sales reach certain levels; and escalating royalties on global sales. Sanofi-aventis and Oxford BioMedica are co-funding the ongoing TRIST study and sanofi-aventis is committed to fund all other research, development, regulatory and commercialisation activities. Furthermore, Oxford BioMedica retains an option to participate in the promotion of TroVax in the USA and the European Union. Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: 'The clinical team at Oxford BioMedica is doing an excellent job in its management of the TRIST study. The trial remains on track to complete recruitment in the first quarter of 2008. It is encouraging that we have reached this milestone of recruiting half of the anticipated patients within a few months of our collaboration with sanofi-aventis.' -Ends- For further information, please contact: Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000 Buchanan Communications Scientific/Trade Press Enquiries: Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7268 3002 Northbank Communications Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene-based therapies with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin-out from Oxford University, and is listed on the London Stock Exchange. The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. In oncology, the lead product candidate is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and sanofi-aventis is implementing a development plan for colorectal cancer. Oxford BioMedica's oncology pipeline includes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, which has completed two clinical trials. In neurotherapy, the Company's lead product, ProSavin(R), is expected to enter clinical development for Parkinson's disease in 2007. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 80 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include sanofi-aventis for TroVax and Wyeth for the targeted antibody therapy. The Company also has collaborations with Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4. Oxford BioMedica and Sanofi-aventis entered a global development and commercialisation agreement for TroVax in March 2007. The companies are co-funding a Phase III trial of TroVax in renal cancer and sanofi-aventis is implementing a Phase III development plan for colorectal cancer. The product has also attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. 3. Phase III TRIST study The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study commenced in November 2006 in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are Sutent(R) (sunitinib), interferon-alpha or interleukin-2. The trial is being conducted at centres in the USA, European Union and Eastern Europe. The primary endpoint for the trial is survival improvement. The trial, which commenced enrolment in November 2006, is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). It is expected to complete in 2009. In July 2007, the independent Data Safety Monitoring Board (DSMB) for the TRIST study completed its first scheduled interim analysis. The DSMB concluded that the trial should continue as planned without modification. For more information on the ongoing Phase III TRIST study of TroVax visit: www.trovax.co.uk This information is provided by RNS The company news service from the London Stock Exchange
UK 100