Oxford Biomedica Regulatory News (OXB)

11 Sep 2007 07:00

Oxford Biomedica PLC11 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 genetherapy company, announced that it has reached the first development milestonein its collaboration with sanofi-aventis for TroVax, the cancer immunotherapy,which triggers a payment of €9 million. The milestone relates to the successfulenrolment of 350 patients in the Phase III TRIST study of TroVax in renalcancer. This represents half of the anticipated 700 patients to be enrolled intothe trial. Oxford BioMedica and sanofi-aventis entered a global development andcommercialisation agreement for TroVax in March 2007. Under the terms of thisagreement, Oxford BioMedica received an initial payment of €29 million. Thisfirst development milestone of €9 million is part of a potential €19 million innear-term milestone payments linked to the Phase III TRIST study. The Companycould receive a total of €518 million in initial and milestone payments ifdevelopment and registration targets are met for certain defined indications.The agreement includes additional undisclosed regulatory milestone payments forother cancer types; undisclosed commercial milestones when sales reach certainlevels; and escalating royalties on global sales. Sanofi-aventis and OxfordBioMedica are co-funding the ongoing TRIST study and sanofi-aventis is committedto fund all other research, development, regulatory and commercialisationactivities. Furthermore, Oxford BioMedica retains an option to participate inthe promotion of TroVax in the USA and the European Union. Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: "Theclinical team at Oxford BioMedica is doing an excellent job in its management ofthe TRIST study. The trial remains on track to complete recruitment in the firstquarter of 2008. It is encouraging that we have reached this milestone ofrecruiting half of the anticipated patients within a few months of ourcollaboration 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 5000Buchanan 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 thedevelopment and commercialisation of novel therapeutic vaccines and gene-basedtherapies with a focus on oncology and neurotherapy. The Company was establishedin 1995 as a spin-out from Oxford University, and is listed on the London StockExchange. The Company has a platform of gene delivery technologies, which are based onhighly engineered viral systems. Oxford BioMedica also has in-house clinical,regulatory and manufacturing know-how. In oncology, the lead product candidateis TroVax(R), an immunotherapy for multiple solid cancers, which is licensed tosanofi-aventis for global development and commercialisation. A Phase III trialof TroVax in renal cancer is ongoing and sanofi-aventis is implementing adevelopment plan for colorectal cancer. Oxford BioMedica's oncology pipelineincludes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, whichhas completed two clinical trials. In neurotherapy, the Company's lead product,ProSavin(R), is expected to enter clinical development for Parkinson's diseasein 2007. The neurotherapy pipeline also includes preclinical gene-basedtherapeutics for vision loss, motor neuron disease and nerve repair. The Company is underpinned by over 80 patent families, which represent one ofthe broadest patent estates in the field. The Company has a staff ofapproximately 80 split between its main facilities in Oxford and its whollyowned subsidiary, BioMedica Inc, in San Diego, California. Corporate partnersinclude 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 andPfizer. Further information is available at www.oxfordbiomedica.co.uk 2. TroVax(R) TroVax is Oxford BioMedica's leading cancer immunotherapy product, which isbeing developed in collaboration with sanofi-aventis. It is designedspecifically to stimulate an anti-cancer immune response and has potentialapplication in most solid tumour types. TroVax targets the tumour antigen 5T4,which is broadly distributed throughout a wide range of solid tumours. Thepresence of 5T4 is correlated with poor prognosis. The product consists of apoxvirus (MVA) gene transfer system, which delivers the gene for 5T4 andstimulates a patient's body to produce an anti-5T4 immune response. This immuneresponse destroys tumour cells carrying the 5T4. Oxford BioMedica and Sanofi-aventis entered a global development andcommercialisation agreement for TroVax in March 2007. The companies areco-funding a Phase III trial of TroVax in renal cancer and sanofi-aventis isimplementing a Phase III development plan for colorectal cancer. The product hasalso attracted support from Cancer Research UK, the US National CancerInstitute, and the UK clinical trials network, QUASAR. 3. Phase III TRIST study The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study commencedin November 2006 in patients with locally advanced or metastatic clear cellrenal carcinoma. The trial is a randomised, placebo-controlled, two-arm studycomparing TroVax in combination with standard of care to placebo with standardof care. The standard of care therapies are Sutent(R) (sunitinib),interferon-alpha or interleukin-2. The trial is being conducted at centres inthe USA, European Union and Eastern Europe. The primary endpoint for the trialis survival improvement. The trial, which commenced enrolment in November 2006,is being conducted under a Special Protocol Assessment (SPA) agreement from theUS Food and Drug Administration (FDA). It is expected to complete in 2009. InJuly 2007, the independent Data Safety Monitoring Board (DSMB) for the TRISTstudy completed its first scheduled interim analysis. The DSMB concluded thatthe 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