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Viragen Milestone

3rd Jun 2005 09:00

Oxford Biomedica PLC03 June 2005 FOR IMMEDIATE RELEASE 3 JUNE 2005 OXFORD BIOMEDICA, VIRAGEN AND THE ROSLIN INSTITUTE REPORT ACHIEVEMENT OF AVIAN TRANSGENIC MILESTONE - Anticancer Antibody Expressed in Chicken Eggs - Oxford, UK: 3 June 2005 - Oxford BioMedica (LSE: OXB), the leading gene therapycompany, Viragen, Inc (AMEX: VRA) and the Roslin Institute (Scotland) todayannounced a breakthrough in their collaborative project to develop AvianTransgenic Biomanufacturing. For the first time, the collaboration has produceda potentially therapeutic protein selectively in the whites of eggs laid by atransgenic hen. This technology is expected to offer a low cost manufacturingalternative for the production of many protein drugs, with additional potentialadvantages in the quality of the products. The therapeutic protein successfully expressed, using Oxford BioMedica'sLentiVector(R) gene delivery system in Viragen's proprietary avian system, is anovel structure of an antibody in Viragen's product portfolio, designed to treatmalignant melanoma. Three other protein-drug candidates are included in ongoingavian expression studies to demonstrate the breadth of its capabilities,including two commercially marketed products, both of which realise more than $2billion in annual sales. Analysis indicates that the protein expression levels in the egg aresignificantly higher than any previously published results for a therapeuticprotein produced from an avian transgenic line. The project's scientific leader, Roslin Senior Scientist, Dr. Helen Sang, Ph.D.,commented on the breakthrough: "We have long believed that this joint effortwould develop an avian system capable of efficiently and economically producinghuman biopharmaceuticals, and with this major milestone achievement, I am evenmore convinced that we are developing an elite manufacturing platform thatshould emerge as a method of choice for many products." Dr. Sang elaborated on how this differs from earlier avian results: "Wepreviously published results demonstrating ubiquitous expression throughout theentire bird. This latest result indicates that we have now been able to targetthe expression so that the functional protein is synthesised as a component ofthe egg white." Viragen's President and CEO, Charles A. Rice, discussed the market opportunity:"The biopharmaceutical drug market is projected to generate in excess of $50billion in sales by 2010, and antibodies alone are expected to make upapproximately $17 billion of that market. Our goal is clear - to develop amanufacturing platform for many of these products that offers compellingadvantages over existing systems." Commenting on the milestone achievement, Oxford BioMedica's CEO, Professor AlanKingsman, said: "We are delighted that our collaborative partner Viragen, withthe Roslin Institute, is making such rapid progress towards the development ofavian-manufactured therapeutic products. The milestone reported today representsa major technical achievement in targeted protein production within a transgenicanimal and further demonstrates the value of the LentiVector system in providinglong-term, stable gene expression that is amenable to tissue-specificregulation. Viragen's achievement, together with today's announcement ofpreclinical efficacy data with Innurex, Oxford BioMedica's LentiVector-basedproduct for nerve repair, emphasise the progress being made and the versatilityof this exceptional gene transfer technology". -Ends- For further information, please contact:Oxford BioMedica plc: Tel: +44 (0)1865 783 000Professor Alan Kingsman, Chief Executive Viragen, Inc: Tel: (954) 233 8746Director of Communications, Doug Calder City/Financial Enquiries: Tel: +44 (0)20 7466 5000Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Buchanan Communications Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150Sue Charles/ Katja Stout/ Ashley LillyNorthbank Communications Notes to editors: 1. Oxford BioMedicaOxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in thedevelopment of novel gene-based therapeutics with a focus on the areas ofoncology and neurotherapy. The Company was established in 1995 as a spin outfrom Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-houseclinical, regulatory and manufacturing know-how. In oncology, the pipelineincludes an immunotherapy and a gene therapy in multiple Phase II trials, and apreclinical targeted antibody therapy in collaboration with Wyeth. Inneurotherapy, the Company's lead product is a gene therapy for Parkinson'sdisease, which is expected to enter clinical trials in early 2006, and fourfurther preclinical candidates. The Company is underpinned by over 80 patentfamilies, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 65 split between its main facilities inOxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Amersham,Viragen, MolMed and Kiadis; and has licensed technology to a number of companiesincluding Merck & Co and Biogen Idec. Further information is available at www.oxfordbiomedica.co.uk. 2. Viragen, IncViragen researches, develops and commercialises pharmaceutical products designedto treat a broad range of viral and malignant diseases. These protein-baseddrugs include: Multiferon(R), a natural human alpha interferon, approved forsale in various international markets; and humanized anti-cancer monoclonalantibodies. Viragen is also pioneering the development of Avian TransgenicTechnology, with the renowned Roslin Institute, as a biomanufacturing platformfor the large-scale, efficient and economical production of therapeuticproteins. For more information, please visit www.viragen.com/. 3. Oxford BioMedica and Viragen collaborationOxford BioMedica licensed its LentiVector gene delivery system to Viragen inJuly 2004 for use of the technology in the development of Avian Transgenics. Theagreement includes upfront and annual licence payments in addition to milestonepayments on the achievement of technical goals and royalties oncommercialisation. 4. LentiVector technologyOxford BioMedica's LentiVector gene delivery technology, based on lentiviruses,is arguably the most potent system currently available for treating a range ofdiseases, particularly those of the central nervous system. Oxford BioMedica hasshown that its lentiviral vectors are able to deliver genes with high efficiencyto a variety of both dividing and non-dividing cells, including neurons in thebrain. Oxford BioMedica has three issued US patents and a European patent for itsLentiVector technology. These include broad composition of matter claims andmethods of production claims for lentiviral vector gene delivery systems of bothhuman and non-human origin. The patents also cover derivatives of lentiviralvector systems that, unlike many versions of lentiviral vectors, have realclinical utility because of their safety. The Company has established a neurotherapy pipeline of product candidates basedon its LentiVector technology. Current licensees of the technology include Merck& Co and Biogen Idec. 5. Avian Transgenic TechnologyViragen holds the worldwide exclusive license to commercialise Avian TransgenicBiomanufacturing Technology as granted by Roslin Institute (Scotland). Theproject is designed to develop the chicken into a pharmaceutical bioreactor, onethat can meet the growing need for protein-based human therapeutics. Based onthe creation of lines of transgenic hens which have been engineered to produce atarget protein in their eggs using Oxford BioMedica's LentiVector system, thistechnology is being developed as an efficient and economical alternative tostandard biomanufacturing techniques, having many apparent advantages in ease ofscale-up, lower costs of production and quality of product produced. This project has been funded in part from a $650,000 grant awarded by theScottish Executive's "SPUR Plus Programme", designed to support significanttechnological advances being made in Scotland. This information is provided by RNS The company news service from the London Stock Exchange

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