Business Update
Oxford Biomedica PLC
25 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 gene
therapy company, notes the movement in the share price over the last month and
confirms that it is not aware of any valid reason for the fall. However, the
Company 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 being
evaluated in competition with standard of care. This is incorrect. TroVax will
be used in addition to standard of care. The target label for TroVax is first
line therapy for renal cell carcinoma with standard of care. The development of
the anti-cancer therapy Avastin(R) followed a similar strategy. Avastin is
generating revenue in excess of $2 billion as a treatment that is added to
standard 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. All
studies completed to date have met their endpoints; and TroVax has not failed in
any study or cancer type to date.
The Company continues to make good progress financially and operationally. A
business update is set out below:
Finance - Current Cash
The Company's current cash position and potential revenues from the
collaboration with sanofi-aventis for TroVax immunotherapy provide sufficient
resources for the Company to reach sustained profitability, which is anticipated
in 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 30
June 2007 of £42.7 million; a consequence of receiving approximately £6 million
from sanofi-aventis on achievement of the first development milestone in the
TroVax collaboration.
TroVax(R) - Phase III Update
Patient recruitment in the Phase III TRIST trial of TroVax in renal cancer is on
track. Approximately 450 patients have now been randomised into the study. The
target enrolment is 700 patients, which the Company expects to be completed in
early 2008. This supports the stated time line from both Oxford BioMedica and
sanofi-aventis for final data and potential product registration in renal cancer
in 2009.
On 17 September, sanofi-aventis disclosed details of its planned Phase III trial
of TroVax in metastatic colorectal cancer. Similar to the TRIST trial, this
Phase III study in colorectal cancer will evaluate TroVax versus placebo. The
trial is expected to enrol 1,300 patients. All patients will receive standard of
care (chemotherapy +/- bevacizumab, i.e. Avastin) plus either TroVax or placebo.
The trial will have a primary endpoint of overall survival and an interim
analysis of progression free survival. The trial protocol will be submitted to
the regulatory authorities shortly. Patient recruitment is expected to start in
Q2 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 earlier
stage colorectal cancer patients and is planned to enrol approximately 3,000
patients with recruitment expected to commence in Q2 2008.
ProSavin(R) - CTA Update
As reported, Oxford BioMedica submitted a Clinical Trial Application (CTA) to
conduct a Phase I/II trial of ProSavin to the French Health Products Safety
Agency (AFSSAPS) in July 2007 following several scientific meetings with the
French agency. The review of the CTA is progressing. The trial will be conducted
at the Henri Mondor Hospital in Paris where the Ethics Committee has already
approved the study. Subject to approval by AFSSAPS, Oxford BioMedica expects the
first patient to be treated in late 2007 or early 2008.
Professor Alan Kingsman, Chief Executive of Oxford BioMedica, commented: 'We are
more confident than ever in the strength of our financial position and our
development pipeline. We are on track to achieve our stated development
milestones and we look forward to reporting on some of our key objectives in the
near future. We believe the share price retreat in recent weeks does not reflect
the 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 Executive
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan
Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7268 3002
Gemma Price/ Holly Griffiths/ Katja Stout
Northbank Communications
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development and commercialisation of novel therapeutic vaccines and gene-based
therapies with a focus on oncology and neurotherapy. 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. In oncology, the lead product candidate
is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to
sanofi-aventis for global development and commercialisation. A Phase III trial
of TroVax in renal cancer is ongoing and sanofi-aventis is implementing a
development plan for colorectal cancer. Oxford BioMedica's oncology pipeline
includes a specific immunotherapy candidate, Hi-8(R) MEL, for melanoma, which
has completed two clinical trials. In neurotherapy, the Company's lead product,
ProSavin(R), is expected to enter clinical development for Parkinson's disease
in late 2007 or early 2008. The neurotherapy pipeline also includes preclinical
gene-based therapeutics for vision loss, motor neuron disease and nerve repair.
The Company is underpinned by over 80 patent families, which represent one of
the broadest patent estates in the field. The Company has a staff of
approximately 80 split between its main facilities in Oxford and its wholly
owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners
include 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 and
Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange