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For Immediate Release |
12 JANUARY 2009 |
OXFORD BIOMEDICA ANNOUNCES DISMISSAL OF BAVARIAN NORDIC'S PATENT INFRINGEMENT CLAIMS
Oxford, UK - 12 January 2009: Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the US District Court for the Southern District of California has dismissed the patent infringement claims brought by Bavarian Nordic against Oxford BioMedica plc, BioMedica Inc. and Oxford BioMedica (UK) Ltd. Bavarian Nordic claimed that TroVax, Oxford BioMedica's therapeutic cancer vaccine, infringed Bavarian Nordic's US patents relating to Modified Vaccinia Ankara (MVA).
The motions of Oxford BioMedica plc, BioMedica Inc. and Oxford BioMedica (UK) Ltd to dismiss the case brought by Bavarian Nordic asserted that the activities with regards to TroVax fall within the statutory safe harbour provided by 35 U.S.C. § 271(e)(1), commonly called the Clinical Trial Exemption. This exemption prevents patent infringement actions from being filed against activities reasonably related to obtaining product approval, such as when the product is still being evaluated in clinical trials. The Court granted the motions to dismiss the case without prejudice. The Court found that the allegations set forth in Bavarian Nordic's complaint regarding past and ongoing clinical trials of TroVax did not state a legal claim for patent infringement. Under the Court's rules, Bavarian Nordic could file a new complaint alleging specific acts of infringement within 14 days.
Peter Nolan, Oxford BioMedica's Senior Vice President, Commercial Development, commented: 'We are extremely pleased by the Court's ruling. It has always been our view that Bavarian Nordic's claims were unwarranted and without merit, which the Court has confirmed. With our partner, sanofi-aventis, we will oppose vigorously any further actions to hinder the ongoing development of TroVax and our intent to bring the product to market for the benefit of patients with cancer.'
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For further information, please contact: |
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Oxford BioMedica plc: John Dawson, Chief Executive Officer Nick Woolf, Chief Business Officer |
Tel: +44 (0)1865 783 000 |
JPMorgan Cazenove Limited: James Mitford/ Gina Gibson |
Tel: +44 (0)20 7588 2828 |
City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications |
Tel: +44 (0)20 7466 5000 |
Scientific/Trade Press Enquiries: Katja Stout/ Holly Griffiths/ John McIntyre College Hill Life Sciences |
Tel: +44 (0)20 7457 2020 |
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 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
2. TroVax®
TroVax is Oxford BioMedica's novel therapeutic cancer vaccine, which is being developed in collaboration with sanofi-aventis. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a Modified Vaccinia Ankara vector, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4 antigen.