08 Annual Report and Accounts

RNS Number : 8025P

Oxford Biomedica PLC

31 March 2009

 



FOR IMMEDIATE RELEASE

31 March 2009

OXFORD BIOMEDICA PLC

2008 ANNUAL REPORT AND ACCOUNTS & AGM NOTIFICATION

Oxford UK - 31 March 2009: Oxford BioMedica plc (LSE: OXB) gives notice that copies of the 2008 Annual Report and Accounts and the Notice of Annual General Meeting have been sent to shareholders. These documents are also available on the 'Investors' section of the Company's web site at www.oxfordbiomedica.co.uk. Oxford BioMedica plc has previously announced audited full year 2008 results in its notice of preliminary results on 12 March 2009. 

Copies of these documents have been submitted to the UK Listing Authority for publication through the UK Listing Authority's Document Viewing Facility, which is situated at The Financial Services Authority, 25 The North Colonnade, Canary Wharf, London, E14 5HS (UKLA telephone helpline: [phone]).

Further copies of the 2008 Annual Report and Accounts are available from the Company Secretary, Oxford BioMedica plc, Medawar Centre, Robert Robinson Avenue, Oxford Science Park, Oxford OX4 4GA (telephone number: [phone]).

Oxford BioMedica plc also announces that its Annual General Meeting ('AGM') will be held on Thursday, 4 June 2009. The meeting will be held at the offices of Morrison & Foerster (UK) LLP, 7th Floor, CityPoint, One Ropemaker Street, London EC2Y 9AW, commencing at 11.00 a.m.

In accordance with the requirements of Rule 4.1 of the Disclosure Rules and Transparency Rules of the UK Financial Services Authority which applies in respect of accounting periods commencing after 20 January 2007, the appendix to this announcement contains a description of the principal risks and uncertainties affecting the Group and a responsibility statement.

- Ends -

For further information, please contact:
Oxford BioMedica plc:  John Dawson, Chief Executive 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: Sue Charles/ 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, and a broad development pipeline. Oxford BioMedica's lead product candidates are TroVax®, a therapeutic vaccine for multiple solid cancers, in Phase III development in collaboration with sanofi-aventis; and ProSavin®, a novel gene-based treatment for Parkinson's disease, in Phase I/II development. 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

  Appendix

1. Principal Risks and Uncertainties

Risk assessment and evaluation is an integral part of the Company's planning. Most of the risks and uncertainties are common to all development-stage biopharmaceutical companies. Where possible, our strategy is designed to manage and mitigate these issues. 

Intellectual Property and Patent Protection Risk

Our commercial success depends, amongst other things, on maintaining proprietary rights to our products and technologies and the Board gives high priority to the strategic management of our intellectual property portfolio. There can be no assurance that our products and technologies are adequately protected by intellectual property. If proceedings are initiated against our patents, the defence of such rights could involve substantial costs and an uncertain outcome. 

Third-party patents may emerge containing claims that impact our freedom to operate. There can be no assurance that we will be able to obtain licences to these patents at reasonable cost, if at all, or be able to develop or obtain alternative technology. 

Development Risk

Safety or efficacy issues may arise at any stage of the drug development process. Adverse or inconclusive results from preclinical testing or clinical trials may substantially delay, or halt, the development of our product candidates, consequently affecting our timelines for profitability. 

As we experienced with the TRIST study of TroVax, results of clinical trials may differ from those obtained in previous clinical studies. We are working with sanofi-aventis to secure the FDA's support for the start of further trials of TroVax. Although we remain confident, there is no assurance that we will secure the FDA's support without delay or additional cost. 

Similarly, the encouraging preclinical results with ProSavin and many of our other product candidates may not be reproduced in clinical trials. In the case of ProSavin, the initial Phase I/II data have provided encouraging confirmation of the product's safety and potential benefit in patients.

Regulatory Approval Risk

Our product candidates will require regulatory approval by agencies such as the FDA and EMEA to be launched in their respective territories. There can be no assurance of gaining the necessary approvals. Each regulatory authority may impose its own restrictions on the product's use or may require additional data before granting approval.

Collaboration and Third-party Risk

Collaborations and licensing are an important component of our strategy to maximise value and minimise risk. There can be no assurance that our existing relationships will not be terminated or require re-negotiation.

Our most important alliances are with sanofi-aventis and Wyeth. The new management of sanofi-aventis is conducting an internal portfolio review, including its collaborative programmes, which is expected to conclude by the end of April 2009.

Circumstances may also arise where the failure by collaborators and third parties, such as contract manufacturers, to perform their obligations in accordance with our agreements could delay, or halt entirely, development, production or commercialisation of our products, or adversely impact our cash flows. 

Pharmaceutical Pricing Risk

The ability of Oxford BioMedica and our partners to commercialise our products may depend on the availability of reimbursement from government health administration authorities, private health coverage insurers and other organisations. There is no assurance that adequate reimbursement will be available or that satisfactory price levels will be reached. 

There is pressure in all territories to contain healthcare costs by limiting both coverage and the level of reimbursement. ProSavin and our other LentiVector-based product candidates have the unique potential to provide a permanent effect from a single administration. The pricing of these therapies will be assessed on the basis of their cost effectiveness. 

Competition Risk

Our competitors, and potential competitors, include major pharmaceutical and biotechnology companies, many of whom have substantially greater resources than us. Through our collaborative strategy, we aim to work with leading companies in respective therapeutic areas. However, there can be no assurance that competitors will not succeed in developing products and technologies that are more effective or economic than ours.

Financial Risk

We expect to record a net cash outflow from operations in 2009 as we continue to invest in our research and development efforts, although we aim to offset our costs through partnering and other licensing income. We have sufficient working capital for our current operating activities into the second half of 2010 and we continue to review our cost base. 

We may require additional financing for the future operation of our business, including further equity funding as appropriate. There is no certainty that adequate resources will be available on a timely basis, particularly if the difficult conditions of financial markets persist. 

Staff Risk

While we have employment contracts with all of our personnel, the retention of their services cannot be guaranteed. Recruiting and retaining key management and scientific personnel is critical to our success.

Gene Therapy Risk

No gene-based medicines are currently approved for sale in the USA or EU. The commercial success of our products will depend, in part, on acceptance by the medical community and the public. Furthermore, specific regulatory requirements, over and above those imposed on other products, apply to gene therapy and there can be no assurance that additional requirements will not be imposed in the future. This may increase the cost and time required for successful development of our products. 

2. Directors' responsibility statement

Each of the Directors, whose names and functions are listed below confirm that, to the best of their knowledge:

• the Group Financial Statements, which have been prepared in accordance with IFRSs as adopted by the EU, give a true and fair view of the assets, liabilities, financial position and loss of the Group; and

• the Directors' report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the principal risks and uncertainties that it faces. 

Name	Function
Professor Alan Kingsman	Chairman
Nick Rodgers	Deputy Chairman and Senior Independent Director
John Dawson	Chief Executive Officer
Mark Berninger	Non-Executive Director
Dr Alex Lewis	Non-Executive Director
Dr Stuart Naylor	Chief Scientific Officer
Peter Nolan	Senior Vice President: Commercial Development
Andrew Wood	Chief Financial Officer
Nick Woolf	Chief Business Officer

 

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