RNS Number : 3761J
Oxford Biomedica PLC
29 March 2010



29 March 2010






Oxford UK - 29 March 2010: Oxford BioMedica plc (LSE: OXB) gives notice that copies of the 2009 Annual Report and Accounts and the Notice of Annual General Meeting have been sent to shareholders. These documents are 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 2009 results in its notice of preliminary results on 10 March 2010.


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: +44 (0) 20 7066 8333).

Further copies of the 2009 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: +44 (0) 1865 783000).

Oxford BioMedica plc also announces that its Annual General Meeting ("AGM") will be held on Tuesday 27 April 2010. 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, 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: +44 (0)1865 783 000

JPMorgan Cazenove Limited:

James Mitford/ Gina Gibson


Tel: +44 (0)20 7588 2828

City/Financial/Press Enquiries:

Lisa Baderoon/ Mark Court/

Buchanan Communications


Tel: +44 (0)20 7466 5000

US Enquiries:

Thomas Fechtner

The Trout Group LLC


Tel: (646) 378 2900


Notes to editors


1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient gene delivery system (LentiVector®), which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline and its partners include sanofi-aventis, Sigma-Aldrich and Pfizer. Technology licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer. Further information is available at www.oxfordbiomedica.co.uk




1. Principal Risks and Uncertainties


Risk assessment and evaluation is an integral part of our planning. Most of our 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 and Regulatory 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.


The clinical development and marketing approval of our product candidates are regulated by healthcare regulatory agencies, such as the FDA, EMA, AFSSAPS and MHRA, in respective territories. During the development stage, regulatory reviews of clinical trial applications or amendments can prolong our anticipated development timelines. Similarly, there can be no assurance of gaining the necessary marketing approvals to commercialise our products. 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 realise value and manage risk. There can be no assurance that our existing relationships will not be terminated or require re-negotiation for reasons that may be unrelated to the potential of the programme.


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. Our LentiVector-based product candidates have the unique potential to provide permanent therapeutic benefit from a single administration. The pricing of these therapies will depend on assessments of their cost-benefit and 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 recorded a net cash inflow from operations in 2009 as a result of our business development activities. Under the terms of our collaborations, the receipt of further income is dependent on the achievement of specific milestones related to development, regulatory or commercial progress. Similarly, the timing and magnitude of income from new collaborations is inherently unpredictable.


Our strategy is to add value to our priority in-house programmes by investing in further development. We aim to offset our operating costs through partnering and other licensing income. Based on our current budget, we have sufficient working capital to support our operating activities until the beginning of 2012 in the absence of income from new collaborations.


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.


Professor Alan Kingsman


Dr Paul Blake

Non-Executive Director

Dr Andrew Heath

Non-Executive Director

Dr Alex Lewis

Non-Executive Director

Nick Rodgers

Deputy Chairman and Senior Independent Director

John Dawson

Chief Executive Officer

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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