OXFORD BIOMEDICA'S TROVAX RECEIVES POSITIVE RECOMMENDATION FOR ORPHAN DRUG DESIGNATION IN RENAL CANCER FROM EMEA

Oxford, UK – 8 December 2006: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that it has received positive opinion from the Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation for TroVax for the treatment of patients with renal cancer in the European Union (EU). The COMP is part of the European Medicines Agency (EMEA). Final adoption of the opinion is expected from the European Commission in early 2007.

European orphan drug designation ensures a ten-year marketing exclusivity for TroVax within the EU. In addition, Oxford BioMedica and its prospective partner will benefit from a simplified, accelerated and cost-effective approval procedure under the consultative guidance of the EMEA. The Company plans to request the equivalent orphan drug status in the USA.

EU orphan drug designation was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the EU. Renal cancer represents any malignant tumour with its origin in the tissues of the kidneys. More than 150,000 people are newly diagnosed with renal cancer worldwide each year. Prognosis is very poor. If renal cancer has metastasised to other organs at the time of first diagnosis, the five-year survival rate is less than 5%. In the USA and Europe, renal cancer accounts for more than 33,000 deaths each year. Data from IMS suggest that over 5,000 patients in the UK received treatment for metastatic renal cancer in 2005.

Dr Mike McDonald, Oxford BioMedica’s Chief Medical Officer, commented on the news: “This positive recommendation from the EMEA for orphan drug designation adds further momentum to the development of TroVax. It underscores the need for effective treatments for renal cancer, where treatment options are limited and the prognosis is poor.”

Oxford BioMedica commenced a pivotal multi-centre Phase III trial of TroVax in renal cancer in November 2006. The Phase III trial, denoted TRIST (TroVax Renal Immunotherapy Survival Trial), is designed to evaluate whether TroVax immunotherapy, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal carcinoma. Approximately 700 patients will be recruited from about 120 centres in the USA, EU and Eastern Europe. The primary endpoint for the trial is survival improvement. Oxford BioMedica received a Special Protocol Assessment agreement for the TRIST study from the US Food and Drug Administration (FDA). The trial is expected to reach a conclusion in 2008-09, which would support the Company’s objective of reaching product registration in 2009 in the USA and 2010 in the EU.

Oxford BioMedica has a key strategic objective of securing a major corporate partner for the ongoing development and commercialisation of TroVax. The Company has progressed to negotiations of terms with its lead prospective partners and remains committed to finalising a deal expeditiously.

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Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics 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.

Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes two clinical candidates and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. The Company has started Phase III development of its lead cancer immunotherapy product, TroVax, in renal cancer and multiple Phase II trials in various cancer settings are ongoing or planned. In neurotherapy, the Company’s lead product, ProSavin, is expected to enter clinical trials in Parkinson’s disease in 2007. The preclinical pipeline includes gene-based products 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 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer.

Further information is available at www.oxfordbiomedica.co.uk

2. TroVax®

TroVax is Oxford BioMedica’s leading cancer immunotherapy product. 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. The Company is targeting colorectal cancer and renal cell carcinoma as lead indications for the development of TroVax. Renal cell carcinoma is an indication where TroVax might achieve a rapid route to product registration. Oxford BioMedica has started a Phase III trial (TRIST – TroVax Renal Immunotherapy Survival Trial) in 700 patients with advanced renal cell carcinoma (www.trovax.co.uk). The TRIST study received a Special Protocol Assessment from the US Food and Drug Administration in May 2006. A Phase II trial in prostate cancer is ongoing and a trial in breast cancer is due to start under the auspices of the US Southwest Oncology Group.

To date, over 160 patients with colorectal, renal or prostate cancer (collectively over 550 doses) have been treated with TroVax. The product has attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. These organisations are already conducting or plan to conduct clinical trials with TroVax.