OXFORD BIOMEDICA AND VIRAGEN REPORT PROGRESS IN AVIAN TRANSGENICS BIOMANUFACTURING

Oxford, UK:  17 February 2005 – Oxford BioMedica (LSE: OXB), the leading gene therapy company, today announced progress in the programme of its collaborative partner Viragen, Inc (AMEX: VRA). Viragen, in collaboration with the Roslin Institute, is developing avian transgenic biomanufacturing for the purpose of using chickens as bioreactors for the efficient and economical production of human pharmaceutical protein-based drugs in their eggs.

Viragen reported that an antibody designed to treat malignant melanoma (anti-GD3 antibody) has been successfully detected in the blood of a founder transgenic rooster after the antibody was introduced using Oxford BioMedica’s proprietary LentiVector^® gene delivery system. This achievement is the first in a series of steps designed to confirm that a humanised antibody can be produced in subsequent generations of chickens and demonstrate a fully intact structure capable of its intended therapeutic function.

Project Leader, Roslin’s Dr. Helen Sang, explained: “We have previously demonstrated that a reporter gene can be synthesised in the oviduct of laying hens, the source of egg white proteins. The significance of this new milestone is that we are now using a humanised anti-cancer antibody which has been incorporated into the bird’s DNA.”

Dr. Sang also discussed the project’s goal to demonstrate tissue-specific expression in the oviduct: “We have now shown that a protein can be synthesised in the oviduct of transgenic hens, the source of egg white proteins. These results indicate that we are well advanced towards our stated target of tissue-specific expression of a therapeutic protein – a key milestone in our development plan.”

“These collective results are extremely encouraging and give us good reason to believe that additional important milestones could be reported in the coming months,” stated Viragen’s President and CEO, Mr. Charles A. Rice.  “We are developing similar work utilising a second therapeutic protein which has global sales of approximately $2 billion. As we continue to realise these significant milestone events, the time is approaching for scheduling meetings with the appropriate international regulatory agencies, including the FDA, to determine the steps that will be required to bring this exciting technology to the market.”

In other avian transgenic-related news, it was announced that a scientific article has been published in Drug Discovery Today (Volume 10, Number 3, February 2005).  The article, titled “Transgenic chickens as bioreactors for protein-based drugs”, reports on significant advances to develop avian transgenics.

Co-authored by Dr. Helen Sang*, the article concludes that: “Recent improvements of transgenic technology for chickens and preliminary results on protein expression in birds are encouraging.”

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*Authors: Simon G. Lillico, Michael J. McGrew, Adrian Sherman and Helen M. Sang; Roslin Institute

Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) 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 development in 2005, 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 approx. 65 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, Amersham, Viragen, MolMed and Kiadis; and has licensed technology to a number of companies including Merck & Co and Biogen Idec.  

Further information is available at http://www.oxfordbiomedica.co.uk 

2. LentiVector^® technology

Oxford BioMedica’s LentiVector gene delivery technology, based on lentiviral vectors, 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 a comprehensive portfolio of US and European patents covering the LentiVector technology, which supports the LentiVector-based pipeline and its technology licensing activities. The Company has established a neurotherapy pipeline of product candidates based on the technology, which includes ProSavin^® for Parkinson’s disease, RetinoStat^® for retinopathy, MoNudin^® for motor neuron disease and Innurex^® for nerve repair. In addition to its application in therapeutic products, the LentiVector technology is an effective tool for genomics-based target validation, screening, production systems, and the creation of transgenic animals. 

3. Viragen, Inc

Viragen (AMEX: VRA) is a biotechnology company specialising in the research, development and commercialisation of natural and recombinant protein-based drugs designed to treat a broad range of viral and malignant diseases. These protein-based drugs include natural human alpha interferon, monoclonal antibodies and a peptide drug.  Viragen’s strategy also includes the development of Avian Transgenic Technology as a biomanufacturing platform for the large-scale, cost-effective production of therapeutic proteins. 

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, Cancer Research UK, University of Nottingham (U.K.), University of Miami, America’s Blood Centers and the German Red Cross. 

For more information, please visit: http://www.viragen.com/

For an Avian Transgenic Technology Profile, please visit:

http://www.viragen.com/aviantechprofile.pdf

4. Oxford BioMedica and Viragen collaboration

On 5 July 2004, Oxford BioMedica and Viragen entered a license agreement for Oxford BioMedica’s LentiVector gene delivery technology. The agreement provides Viragen with worldwide exclusive rights to utilise the technology in its collaboration with Roslin Institute (Scotland) to develop Avian Transgenic Technology as a novel platform for the efficient and economical manufacturing of therapeutic proteins in chicken eggs. Under the agreement, Viragen is funding the development and Oxford BioMedica receives an upfront license fee and annual maintenance payments. In addition, Oxford BioMedica will receive milestone payments on the achievement of technical goals by Viragen and royalties on commercialisation of the Avian Transgenic Technology.