Interim Management Statement

RNS Number : 2181S

Oxford Biomedica PLC

14 May 2009

 



For Immediate Release	14 MAY 2009

OXFORD BIOMEDICA PLC

INTERIM MANAGEMENT STATEMENT 

Oxford, UK - 14 May 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today publishes its interim management statement for the period from 1 January to 13 May 2009. 

Highlights

• New collaboration with sanofi-aventis to develop LentiVector-based treatments for ocular diseases

• Objective to start clinical trials of RetinoStat in wet AMD and StarGen in Stargardt disease in 2010

• Regained rights to TroVax and, subject to outcome of ongoing FDA review, a new partnering initiative is planned

• Encouraging new data emerging from Phase I/II trial of ProSavin in Parkinson's disease

• Strengthened financial resources extends cash for operations into 2012

Commercial activities - new relationship with sanofi-aventis 

In April 2009, we announced two major commercial events regarding our relationship with sanofi-aventis. We entered a new collaboration with sanofi-aventis to develop gene-based treatments for ocular diseases, using our LentiVector technology. Separately, we regained worldwide rights to TroVax, our therapeutic cancer vaccine, as part of sanofi-aventis's reprioritisation of its product portfolio. The immediate payments from sanofi-aventis associated with these two events amounted to £29 million, which comprised an upfront payment of £18 million for the ocular collaboration and £11 million in relation to their decision to forego further development of TroVax.

TroVax® for cancer - TRIST study provides valuable insights for further development

The Phase III TRIST study of TroVax in renal cancer provides further evidence that links patients' immune response to the 5T4 tumour antigen with improved survival, despite the study not meeting its primary endpoint. From our analysis of the data, we believe it may be possible to use routine baseline markers to identify patients that are more likely to benefit from TroVax and that these will be of significant value in the design of future studies. Approximately 50% of patients in the TRIST study met these prognostic criteria. 

Subject to the outcome of our ongoing dialogue with the FDA, our objective is to secure a new partner to develop and commercialise TroVax. The FDA requested to review the results from the TRIST study, primarily the safety data. A meeting with the FDA has now been scheduled for June 2009 and, once we have received the agency's guidance on the next steps for trials of TroVax, we plan to report the detailed results from the study. 

ProSavin® for Parkinson's disease - new data confirm potential for long-term efficacy

All patients treated to-date in the Phase I/II trial of ProSavin in Parkinson's disease have shown encouraging improvement in their motor function and in other measures of clinical benefit. The first patient treated in the trial in March 2008 has maintained their improvement at 12 months, which supports our expectation that ProSavin could provide sustained benefit from a single administration. We aim to report updated results, including the initial data from the second dose level, following a review of the data by the independent Data Monitoring Committee (DMC). The outcome of the DMC's review is expected in July 2009. 

Our objective is to complete the trial in the second half of 2010 and advance directly into a registration Phase II/III trial. We will continue to work with the local authorities, EMEA and FDA on the overall development plan towards registration.

Ocular collaboration with sanofi-aventis - validation of LentiVector® technology 

Our new collaboration with sanofi-aventis in ophthalmology is a significant milestone for the Company. It is the first commercial deal to exploit the potential of our LentiVector technology for drug development. In addition to the upfront payment, sanofi-aventis has committed funding of up to £16 million over three years to advance four ocular products into Phase I/II trials. If successful, Oxford BioMedica will receive further undisclosed license fees, milestone payments and royalties on product sales, the terms of which are consistent with other deals of this size and scope.

The agreement covers four LentiVector-based product candidates in the field of ophthalmology: RetinoStat® for wet age-related macular degeneration (AMD), StarGen™ for Stargardt disease, UshStat™ for Usher syndrome 1B and EncorStat™ for corneal graft rejection. The four products are addressing key unmet medical needs. There are no existing treatments for Stargardt disease, Usher syndrome 1B or corneal graft rejection. All four products are currently in preclinical development. RetinoStat and StarGen are the most advanced and, under the joint development plan, both products are expected to enter clinical trials before the end of 2010.

Financial review - cash position significantly strengthened 

The new ocular collaboration with sanofi-aventis and the termination of the TroVax collaboration will have a significant positive effect on the Company's financial results for the current year and on the medium-term outlook. Based on these events, recognised revenue for 2009 is expected to be approximately £20 million (2008: £18 million). Income and expenditure for the period ended 13 May 2009, excluding items related to our relationship with sanofi-aventis, were in line with our expectations and were consistent with the levels in the second half of 2008.

In our statement issued 12 months ago, we reported that net cash1 was sufficient to support ongoing operations to the end of 2009. We implemented decisive cost reduction measures in the second half of 2008 to extend our cash for operations through 2010. Following our recent commercial activities, our financial resources are significantly improved and, based on our current plans, including the new ocular development programmes funded by sanofi-aventis, our current net cash1 is sufficient to support operations into 2012 without recourse to other sources of funds.

Oxford BioMedica's Chief Executive Officer, John Dawson, commented: 'We are pursuing multiple objectives to strengthen the Company and accelerate profitability. Our new collaboration with sanofi-aventis is the first step towards building a more sustainable business by maximising the value of our assets and reducing our exposure to development and financial risk. We continue to be encouraged by the data emerging from the ongoing Phase I/II trial of ProSavin. The product is a key value driver for the Company and we look forward to reporting results from the current stage of the study. In the case of TroVax, we have a constructive dialogue with the FDA and, subject to the outcome of these interactions, we are planning a new partnering initiative. With our enhanced cash position, we are well positioned in this challenging financial environment and I am confident that we can deliver on our other near-term strategic objectives.'     

1. Cash, cash equivalents and current financial assets

-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 Elliott 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 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. Partners include sanofi-aventis, Sigma-Aldrich and Wyeth. Technology licensees include Biogen Idec, GlaxoSmithKline, Merck & Co and Pfizer. 

Further information is available at www.oxfordbiomedica.co.uk

 

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