Oxford Biomedica Regulatory News (OXB)

25 Oct 2007 07:01

Oxford Biomedica PLC25 October 2007 For Immediate Release 25 OCTOBER 2007 OXFORD BIOMEDICA RESPONDS TO SHARE PRICE MOVEMENT AND REPORTS BUSINESS UPDATE Oxford, UK - 25 October 2007: Oxford BioMedica (LSE: OXB), a leading genetherapy company, notes the movement in the share price over the last month andconfirms that it is not aware of any valid reason for the fall. However, theCompany is aware of two misconceptions that are circulating in the market. Firstly, it has been stated that in the Phase III TRIST study, TroVax is beingevaluated in competition with standard of care. This is incorrect. TroVax willbe used in addition to standard of care. The target label for TroVax is firstline therapy for renal cell carcinoma with standard of care. The development ofthe anti-cancer therapy Avastin(R) followed a similar strategy. Avastin isgenerating revenue in excess of $2 billion as a treatment that is added tostandard of care for certain metastatic cancers. Secondly, it has been stated that TroVax has failed in an ovarian cancer trial.This is incorrect. TroVax has not yet been evaluated in ovarian cancer. Allstudies completed to date have met their endpoints; and TroVax has not failed inany study or cancer type to date. The Company continues to make good progress financially and operationally. Abusiness update is set out below: Finance - Current CashThe Company's current cash position and potential revenues from thecollaboration with sanofi-aventis for TroVax immunotherapy provide sufficientresources for the Company to reach sustained profitability, which is anticipatedin 2009. The Company's net cash position at 30 September 2007 was approximately£44 million, which is slightly higher than the reported net cash1 position at 30June 2007 of £42.7 million; a consequence of receiving approximately £6 millionfrom sanofi-aventis on achievement of the first development milestone in theTroVax collaboration. TroVax(R) - Phase III UpdatePatient recruitment in the Phase III TRIST trial of TroVax in renal cancer is ontrack. Approximately 450 patients have now been randomised into the study. Thetarget enrolment is 700 patients, which the Company expects to be completed inearly 2008. This supports the stated time line from both Oxford BioMedica andsanofi-aventis for final data and potential product registration in renal cancerin 2009. On 17 September, sanofi-aventis disclosed details of its planned Phase III trialof TroVax in metastatic colorectal cancer. Similar to the TRIST trial, thisPhase III study in colorectal cancer will evaluate TroVax versus placebo. Thetrial is expected to enrol 1,300 patients. All patients will receive standard ofcare (chemotherapy +/- bevacizumab, i.e. Avastin) plus either TroVax or placebo.The trial will have a primary endpoint of overall survival and an interimanalysis of progression free survival. The trial protocol will be submitted tothe regulatory authorities shortly. Patient recruitment is expected to start inQ2 2008. A third Phase III trial is planned by the UK clinical trials network, QUASAR,with support from sanofi-aventis and Oxford BioMedica. This trial is in earlierstage colorectal cancer patients and is planned to enrol approximately 3,000patients with recruitment expected to commence in Q2 2008. ProSavin(R) - CTA UpdateAs reported, Oxford BioMedica submitted a Clinical Trial Application (CTA) toconduct a Phase I/II trial of ProSavin to the French Health Products SafetyAgency (AFSSAPS) in July 2007 following several scientific meetings with theFrench agency. The review of the CTA is progressing. The trial will be conductedat the Henri Mondor Hospital in Paris where the Ethics Committee has alreadyapproved the study. Subject to approval by AFSSAPS, Oxford BioMedica expects thefirst patient to be treated in late 2007 or early 2008. Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: "We aremore confident than ever in the strength of our financial position and ourdevelopment pipeline. We are on track to achieve our stated developmentmilestones and we look forward to reporting on some of our key objectives in thenear future. We believe the share price retreat in recent weeks does not reflectthe fundamental strength of Oxford BioMedica today." -Ends- 1. Net cash position comprises cash, cash equivalents and current financial assets For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief ExecutiveCity/Financial Enquiries: Tel: +44 (0)20 7466 5000 Lisa Baderoon/ Mark Court/ Mary-Jane Johnson BuchananCommunicationsScientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002 Gemma Price/ Holly Griffiths/ Katja StoutNorthbank Communications Notes to editors 1. Oxford BioMedicaOxford 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 late 2007 or early 2008. The neurotherapy pipeline also includes preclinicalgene-based therapeutics 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 This information is provided by RNS The company news service from the London Stock Exchange