Interim Management Statement

RNS Number : 3231I

Oxford Biomedica PLC

18 November 2008

 



For Immediate Release	18 NOVEMBER 2008

OXFORD BIOMEDICA PLC

INTERIM MANAGEMENT STATEMENT 

Oxford, UK - 18 November 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today publishes its interim management statement for the period from 1 July to 17 November 2008. 

Operational highlights:

• Recommendation from Data Safety Monitoring Board that the TroVax Phase III TRIST study in renal cancer would not meet its predefined primary endpoint but should be continued without further vaccinations

• Agreement with the US FDA to amend the TroVax TRIST study to explore whether patient outcome is dependent on the number of doses, background standard of care and patients' prognostic factors

• Commitment from sanofi-aventis to proceed with the planned colorectal programme of TroVax pending FDA agreement

• TroVax cross-trial analysis indicates association between anti-cancer immune response and increased patient survival. Results presented at the EORTC-NCI-AACR Symposium

• Interim Phase I/II results with first dose level of ProSavin in Parkinson's disease show good safety and indications of efficacy at three months

• Initiated discussions with the FDA for Phase I/II trial of RetinoStat in neovascular age-related macular degeneration. Clinical preparations proceeding to plan 

Board changes:

A number of changes to the Board were announced with the interim results on 29 August 2008. Subsequent to these changes, John Dawson was appointed as permanent Chief Executive Officer on 13 October 2008, having served as Acting Chief Executive Officer since 29 August 2008. John is an experienced pharmaceutical business leader with extensive experience in the business development arena and has led and grown businesses both organically and by acquisition. From 1996 to 2007, he held senior management positions in the European operations of Cephalon Inc. He was instrumental in the many deals that built the European business to over 1,000 people and from zero sales in 1998 to a turnover of over US$300 million.

Financial review: 

In the last quarter, the Company has carried out a strategic review and restructuring to reduce operating expenses, concentrating resources on key development priorities for TroVax, ProSavin and RetinoStat. This initiative has resulted in a reduction in head count of 15% to 77 and a decrease in other expenses through operational efficiencies. The Company reported a net cash balance of £27.0 million at 30 June 2008. Net expenditure and cash flow in the period from 1 July to 17 November 2008 were in line with the revised budget. 

Financial outlook:

The revised strategic plan is delivering significant cost savings. The Company will continue to monitor and adjust expenditure going forward. The strategic review has also highlighted areas of the development and intellectual property portfolio that provide a focus for increased business development activity. These measures are expected to extend cash for operations through 2010. Restructuring costs in the second half of 2008 related to the headcount reduction are expected to be less than £0.1 million. The Company is maintaining its revenue guidance for the full year 2008, comprising milestone payments received and release of deferred income, in the range of £16-19 million, which is an increase of approximately 140% over 2007. 

Oxford BioMedica's Chief Executive Officer, John Dawson, commented: 'Since taking on my executive role at Oxford BioMedica in August, the Company has progressed on several fronts. We were encouraged by the feedback from the FDA on the TroVax TRIST study and we are delighted that sanofi-aventis has confirmed its support and, pending FDA agreement, its intention to proceed with further trials. The Phase I/II trial of ProSavin is on track and we look forward to reporting more data from the study. We have progressed discussions with potential partners and various organisations regarding ProSavin and our other pipeline products, with the objective of accelerating their development. In addition, we are evaluating a number of strategic opportunities that could add new drivers of growth for the Company. With our strong financial position and upcoming development milestones, we are well positioned to build the business and create long-term value for shareholders.' 

-Ends-

For further information, please contact:
Oxford BioMedica plc:  John Dawson, Chief Executive Officer Nick Woolf, Chief Business Officer	Tel: [phone]
JPMorgan Cazenove Limited: James Mitford/ Gina Gibson	Tel: [phone]
City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications	Tel: [phone]
Scientific/Trade Press Enquiries: Katja Stout/ Holly Griffiths/ John McIntyre College Hill Life Sciences	Tel: [phone]
US Enquiries: Thomas Fechtner The Trout Group LLC	Tel: [phone]

Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer immunotherapy and gene-based therapies. 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. The lead product candidate is TroVax, a therapeutic vaccine for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. TroVax is in Phase III development. Oxford BioMedica has three other products in clinical development, including ProSavin, a novel gene-based treatment for Parkinson's disease, in a Phase I/II trial. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk

 

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