Viragen Milestone

Oxford Biomedica PLC 18 January 2006 IMMEDIATE RELEASE 18 JANUARY 2006 OXFORD BIOMEDICA AND VIRAGEN REPORT AVIAN TRANSGENIC BREAKTHROUGH - OVA(TM) System Expresses Interferon Beta - Oxford, UK: 18 January 2006 - Oxford BioMedica (LSE: OXB) announced today that its partner Viragen, Inc (AMEX: VRA), along with Viragen's collaborators at the Roslin Institute, have successfully achieved expression of significant quantities of the human protein, interferon beta-1a, in the whites of eggs laid by transgenic hens using the OVA(TM) System (Avian Transgenic Biomanufacturing) that employs Oxford BioMedica's LentiVector(R) technology. Interferon-beta is a key component of the human immune system and is the active ingredient in several leading multiple sclerosis (MS) therapies. These results are the first in a series of anticipated milestones demonstrating 'Proof-of-Principle' with an avian-expressed version of interferon beta, and it is expected that the OVA(TM) System will be capable of cost-effectively expressing many types of therapeutic proteins. Viragen and Roslin are conducting avian expression studies on various protein candidates including interferon beta-1a, which is currently marketed under two competing brand names for the treatment of MS. These MS products are Avonex(R)*, marketed by Biogen Idec, and Rebif(R)**, marketed by Serono, with combined annual global sales over $2.5 billion. The Project's Scientific Leader, Dr. Helen Sang of Scotland's Roslin Institute, commented, 'We are extremely pleased to report this key advance in our programme to develop a preferred platform for the production of selected biopharmaceutical proteins, having now successfully developed transgenic hens that are synthesising significant quantities of interferon beta as a component of their egg white. This is the second protein candidate with which we have achieved promising results, as we previously reported expression and recovery of a functional humanised antibody. As we fully characterize the interferon beta that is recovered, both biochemically and by functional tests, we expect such results will confirm our progress.' 'This is a truly remarkable achievement for our team in Scotland and represents a major event towards our goal to definitively position the OVA(TM)System as a revolutionary transgenic bio-manufacturing alternative,' stated Dr. Karen Jervis, Vice President and Managing Director of Viragen (Scotland) Ltd. 'We will continue to collect eggs from these hens and subsequent generations to confirm quality and quantity of the protein. In addition, we will be analysing the carbohydrate profile of the product, which may represent another key advantage to OVA(TM)expressed proteins. Certain biotech drugs require post-translational modifications in order that the drug retains its full efficacy and is well tolerated when used as a human therapeutic. Although we must confirm the nature of the modifications conferred by the OVA(TM)System, we are hopeful that avian transgenic production may be able to retain these beneficial modifications, which may in turn translate to a lower cost of goods and a more economical process.' While more data are required to provide a precise economic model, Viragen's President & CEO, Charles A. Rice, stressed the significance of this achievement, 'We are continuing to report historic scientific breakthroughs, as we achieve the essential prerequisites to develop a viable, cost-effective, transgenic bio-manufacturing system. To imagine the potential, based on the highest expression levels we have found, it is conceivable that a small flock of a couple of hundred hens could satisfy the entire US market demand for interferon beta-1a. These figures are preliminary, but certainly suggest why this technology might be so desirable to a company seeking new benefits in the manufacturing of current and future products. We congratulate our Scotland teams at VSL and the Roslin Institute for their commitment, patience, perseverance and fine work on this important project, and we look forward to even more dramatic results throughout this year.' *Avonex(R) (interferon beta-1a) is a registered trademark of Biogen Idec, Inc. ** Rebif(R) (interferon beta-1a) is a registered trademark of Serono, Inc. Viragen has no agreements with Biogen Idec or Serono and did not collaborate with either company in connection with these avian expression studies. -Ends- For further information, please contact: Oxford BioMedica plc: Tel: +44 (0)1865 783 000 Professor Alan Kingsman, Chief Executive Viragen, Inc: Tel: (954) 233 8746 Director of Communications, Doug Calder 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 7886 8150 Katja Stout/ Gemma Bradley Northbank Communications Notes to editors: 1. Oxford BioMedica Oxford BioMedica (LSE: OXB), the leading gene therapy company, is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on the areas of oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange. Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes an immunotherapy and a gene therapy in multiple Phase II trials, and a preclinical targeted antibody therapy in collaboration with Wyeth. In neurotherapy, the Company's lead product is a gene therapy for Parkinson's disease, which is expected to enter clinical trials in 2006, and four further preclinical candidates. 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 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec and Pfizer. Further information is available at www.oxfordbiomedica.co.uk 2. Viragen, Inc With global operations in the USA, Scotland and Sweden, Viragen is a biotechnology company engaged in the research, development, manufacture and commercialization of pharmaceutical proteins for the treatment of viral diseases and cancers. Viragen's product portfolio includes: Multiferon(R) (multi-subtype, natural human alpha interferon) targeting a broad range of infectious and malignant diseases; and humanised monoclonal antibodies targeting specific antigens over-expressed on many types of cancers. Viragen is also pioneering the development of Avian Transgenic Technology, with the renowned Roslin Institute, as a revolutionary manufacturing platform for the large-scale, efficient and economical production of human therapeutic proteins and antibodies. For more information, please visit www.viragen.com 3. Oxford BioMedica and Viragen collaboration Oxford BioMedica licensed its LentiVector gene delivery system to Viragen in July 2004 for use of the technology in the development of Avian Transgenics. The agreement includes upfront and annual licence payments in addition to milestone payments on the achievement of technical goals and royalties on commercialisation. 4. LentiVector(R) technology Oxford BioMedica's LentiVector gene delivery technology, based on lentiviruses, is arguably the most potent system currently available for treating a range of diseases, particularly those of the central nervous system. Oxford BioMedica has shown that its lentiviral vectors are able to deliver genes with high efficiency to a variety of both dividing and non-dividing cells, including neurons in the brain. Oxford BioMedica has three issued US patents and a European patent for its LentiVector technology. These include broad composition of matter claims and methods of production claims for lentiviral vector gene delivery systems of both human and non-human origin. The patents also cover derivatives of lentiviral vector systems that, unlike many versions of lentiviral vectors, have real clinical utility because of their safety. The Company has established a neurotherapy pipeline of product candidates based on its LentiVector technology, which includes ProSavin(R) for Parkinson's disease, RetinoStat(R) for retinopathy, MoNudin(R) for motor neuron disease, SMN1-G for spinal muscular atrophy and Innurex(R) for nerve repair. 5. OVA(TM)System Viragen holds the worldwide exclusive license to commercialise the OVA(TM) System (Avian Transgenic Biomanufacturing) as granted by the Roslin Institute (Scotland). The project is designed to develop the chicken into a pharmaceutical bioreactor, one that can meet the growing need for protein-based human therapeutics. Based on the creation of lines of transgenic hens which have been engineered to produce a target protein in their eggs using the LentiVector gene delivery system licensed from Oxford BioMedica, this technology is being developed as an efficient and economical alternative to standard bio-manufacturing techniques, having many apparent advantages in ease of scale-up, lower costs of production and quality of product produced. This project has been funded in part from a grant awarded by the Scottish Executive's 'SPUR Plus Program', designed to support significant technological advances being made in Scotland. This information is provided by RNS The company news service from the London Stock Exchange
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