Option Agreement

Oxford Biomedica PLC 18 March 2003 18 March 2003 OXFORD BIOMEDICA AGREEMENT WITH VIRAGEN INC RE: LICENCE TO LENTIVECTOR TECHNOLOGY Oxford, UK: 18 March 2003 - Oxford BioMedica announced that it has signed an option agreement with the US biotechnology company Viragen Inc that may lead to a licence for the use of Oxford BioMedica's LentiVector(R) gene transfer technology for the production of therapeutic proteins from the eggs of transgenic chickens. The attached announcement by Viragen provides more detailed information. -Ends- For further information, please contact: Oxford BioMedica plc Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: Mike Wort, James Chandler: Beattie Financial Tel: +44 (0)20 7398 3300 Scientific/Trade Press Enquiries: Sue Charles, Katja Stout: Northbank Communications Tel: +44 (0)20 7321 3870 Notes to Editors Oxford BioMedica (www.oxfordbiomedica.co.uk) Established in 1995 as a spin out from Oxford University, Oxford BioMedica plc specialises in the development of novel gene-based therapeutics for the treatment of cancer, neuro-degenerative disease and other disorders with major unmet clinical needs. The development pipeline includes two novel anti-cancer products in clinical trials and a gene therapy treatment for Parkinson's disease, which is in late preclinical studies. This is underpinned by a broad research pipeline and over 70 patent families, about quarter of which are issued. Oxford BioMedica's products use genes as the mediators of a therapeutic effect and/or immune response. The Company's gene therapy products deliver therapeutic molecules in vivo whilst its gene-based immunotherapy products deliver genes that recruit the patient's immune system to mediate a therapeutic effect. The genes are delivered by the Company's highly engineered viruses or cells. BioMedica's lead product TroVax(R) is an anti-cancer therapeutic vaccine expected to be useful against a broad range of tumour types. It is entering Phase II trials in a number of indications including colorectal and renal cancer, and is expected to be ready for Phase III trials at the end of 2003. The Company's second cancer product, MetXia(R), is completing Phase I/II studies in breast cancer. Oxford BioMedica is headquartered in Oxford, UK and has a wholly-owned subsidiary in San Diego, USA. BioMedica has corporate collaborations with Wyeth, IDM, Intervet, Aliga Pharmaceuticals, Amersham and Arius Research. Oxford BioMedica plc was floated on the Alternative Investment Market of the London Stock Exchange in December 1996, and was promoted to the United Kingdom Listing Authority Official List in April 2001 following a successful £35.5 million fund-raising. Viragen Enters into Transgenics Agreement with Oxford BioMedica PLANTATION, FLORIDA - March 18, 2003 - Viragen, Inc. (AMEX: 'VRA') today announced that the Company has entered into an agreement with Oxford BioMedica plc (LSE: 'OXB') to obtain rights to a technology that may prove key in its collaboration with Roslin Institute to develop avian transgenic technology as a novel platform for the efficient, cost-effective manufacturing of protein drugs. The agreement provides Viragen with an option to acquire an exclusive worldwide license for proprietary gene transfer vectors, biotechnology tools designed to transfer genes into cells at high efficiency. Initial studies evaluating a novel use for these vectors, transfer of genes for therapeutic proteins into developing chicken embryos, have yielded successful and consistent results. Terms of the agreement were not disclosed. In order to produce human therapeutic proteins in avian eggs, a gene delivery method must be optimized to transfer genes for therapeutic proteins into chickens, so that subsequent generations of birds will carry the genes and express adequate quantities of the target drugs in the whites of their eggs. Viragen and Roslin utilized Oxford BioMedica's vector technology to conduct a 'Proof of Principle' study. The study successfully resulted in production of transgenic cockerels that pass on the introduced gene to their offspring with consistent results (germline transmission), a milestone achievement. In the study, a 'reporter gene' was used to measure the efficiency of the vectors. Chick embryos were transfected with the reporter gene carried by the vectors and analysis showed that 100% of the resulting male birds possessed the gene in their sperm, meaning that they were successfully transgenic. The second stage of the study involved breeding these first generation transgenic cockerels to determine the frequency of transgenic birds in the next generation. This resulted in successful production of transgenic male and female birds, the frequency far exceeding requirements for commercial viability. 'We continue to develop multiple technology pathways to commercialize avian transgenics, but we are very optimistic about what this agreement with Oxford BioMedica may represent,' stated Viragen's President and CEO, Mr. Robert Salisbury. 'Additional studies are ongoing to further confirm the value of this particular technology.' Roslin Institute's Dr. Helen Sang, one of the world's foremost authorities on avian transgenics research, stated, 'To evaluate the efficiency and consistency of this vector technology, we introduced the Oxford BioMedica vectors into chick embryos and raised hatched chicks for breeding. Nine developed into adult transgenic roosters, indicating that stable transfection had been consistently achieved. We then bred from these roosters to determine the frequency of transgenic offspring produced. Each rooster successfully produced transgenic offspring, with frequencies ranging from one percent to 29 percent of the chicks hatched transgenic. I believe that these results represent a much higher frequency of production of transgenic chickens than those presented in previously published avian transgenics data. Even at our lowest rate, where one in 100 offspring are transgenic, we met the criteria necessary for commercial viability. These are potentially break-through findings and we are hopeful that we will reproduce these results with the targeted expression in hens of a clinically relevant human monoclonal antibody. These studies are ongoing.' Oxford BioMedica's CEO, Professor Alan Kingsman, stated, 'We are very pleased to be associated with Viragen and Roslin in an innovative project to provide an efficient and cost-effective alternative to present drug manufacturing systems. The avian application may represent yet another promising commercial opportunity for our gene delivery technology. We are very excited by Dr. Sang's initial results and we look forward to a long and successful relationship.' Viragen, Inc. Corporate Contacts: Douglas Calder, Director of Communications (Media & Investor Contact) Phone: (954) 233-8746; Fax: (954) 233-1414 E-mail: dcalder@viragen.com About Avian Transgenic Technology Viragen holds the worldwide exclusive license to commercialize Avian Transgenic Technology as granted by Roslin Institute. This project is designed to substitute chicken eggs for expensive bioreactor vessels presently used in the manufacture of protein-based drugs. Upon the successful completion of this project, flocks of specially produced transgenic chickens would lay virtually unlimited numbers of eggs which would have significant amounts of the target drug in the egg whites. The proportion of protein drugs, including monoclonal antibodies, under development is forecast to be expanding rapidly and manufacturing constraints including lack of adequate facilities have been recognized. About Viragen, Inc. Viragen is a biotechnology company specializing in the research, development and commercialization of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases. These protein-based drugs include human natural alpha interferon, monoclonal antibodies, peptide drugs and therapeutic vaccines. Viragen's strategy also includes the development of Avian Transgenic Technology for the large-scale, cost-effective manufacturing of its portfolio of protein-based drugs, as well as offering Contract Manufacturing for the entire biopharmaceutical industry. Viragen is publicly traded on the American Stock Exchange (VRA). Viragen's majority owned subsidiary, Viragen International, Inc., is publicly traded on the Over-The-Counter Bulletin Board (VGNI). Viragen's key partners and licensors include: Roslin Institute, Memorial Sloan-Kettering Cancer Center, National Institutes of Health, Cancer Research UK, University of Nottingham (U.K.), University of Miami, America's Blood Centers and the German Red Cross. This information is provided by RNS The company news service from the London Stock Exchange
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