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DewDiligence

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DewDiligence

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Re: DewDiligence post# 6704

Friday, 06/03/2005 5:48:29 AM

Friday, June 03, 2005 5:48:29 AM

Post# of 253503
With more than a peck of hyperbole…
Viragen provides latest chicken report:

http://www.prnewswire.com/mnr/viragen/22034

>>
Viragen Reports Achievement of Key Avian Transgenics Milestone

Anti-Cancer Antibody Expressed in Chicken Eggs Promises to Revolutionize Drug Production

PLANTATION, Fla., June 3 /PRNewswire-FirstCall/ -- Viragen, Inc. (Amex: VRA ), Roslin Institute (Scotland) and Oxford BioMedica PLC today jointly announced a dramatic breakthrough in their pioneering project to develop Avian Transgenic Biomanufacturing with the report of a functional humanized antibody protein incorporated in the whites of eggs laid by a transgenic hen. This technology is expected to offer a lower-cost manufacturing alternative for the production of many protein drugs, with additional potential advantages in the quality of the products.

The therapeutic protein successfully expressed, using Oxford BioMedica's LentiVector® gene delivery system in this proprietary avian system, is a novel structure of an antibody in Viragen's product portfolio being designed to target malignant melanoma. Three other protein-drug candidates are included in ongoing avian expression studies to demonstrate the breadth of its capabilities, including two commercially marketed products, each of which realizes more than $2 billion in annual sales.

Viragen and Roslin confirmed qualitative and quantitative detection, and recovery of humanized antibody from the eggs. The analysis indicates that the expression levels measured are significantly higher than any previously published results for a therapeutic protein produced from an avian transgenic line.

The Project's scientific leader, Roslin Senior Scientist Dr. Helen Sang, Ph.D., lauded the breakthrough, "We have long believed that this joint effort would develop an avian system capable of efficiently and economically producing human biopharmaceuticals, and with this major milestone achievement, I am even more convinced that we are developing an elite manufacturing platform that should emerge as a method of choice for many products."

Dr. Sang elaborated on how this differs from earlier avian results, "We previously published results demonstrating ubiquitous expression throughout the entire bird. This latest result indicates that we have now been able to target the expression so that the functional protein is synthesized as a component of the 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 $50 billion in sales by 2010, and antibodies alone are expected to make up approximately $17 billion of that market. Our goal is clear -- to develop a manufacturing platform for many of these products that offers compelling advantages over existing systems."

"One of the key advantages we expect to prove is the quality of the drug product. We plan to demonstrate our avian-manufactured products are glycosylated. We believe this is critical to the functionality, safety and tolerability of such biopharmaceuticals. Many existing protein drug products are not glycosylated by virtue of their manufacturing process, which can lead to adverse immune responses and a significantly shorter half-life in the body. So we aim to take such proteins and create new and improved versions, which should be better tolerated, possibly be dosed in lower quantities, and hopefully would be beneficial to the safety of the patients. The market opportunity is enormous," concluded Mr. Rice.

Commenting on the milestone achievement, Oxford BioMedica's CEO, Professor Alan Kingsman, said, "We are delighted that our collaborative partner Viragen, with the Roslin Institute, is making such rapid progress towards the development of avian-manufactured therapeutic products. The milestone reported today represents a major technical achievement and is further evidence of the utility of our LentiVector gene delivery system."

Dr. Sang added, "While I am extremely pleased, I still believe we can further maximize this system's value. With our collective knowledge and experience with these transgenic models, we are initiating additional studies using a further optimized construct that should significantly increase expression levels, even beyond these excellent results."

Viragen will present at the Biotechnology Industry Organization (BIO) 2005 Annual Meeting, the premier global biotechnology event of the year to be held in Philadelphia later this month. Dr. William H. Stimson, Ph.D., Director of Research (Emeritus), has been invited to discuss avian biomanufacturing systems at a BIO-sponsored patient advocacy luncheon, and Mr. Rice will present at the BIO Business Forum. Additional details regarding these presentations will be made available shortly.

About Avian Transgenic Technology:

Viragen holds the worldwide exclusive license to commercialize Avian Transgenic Biomanufacturing Technology as granted by 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 a gene delivery system licensed from Oxford BioMedica PLC, this technology is being developed as an efficient and economical alternative to standard biomanufacturing 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 $650,000 grant awarded by the Scottish Executive's "SPUR Plus Program", designed to support significant technological advances being made in Scotland.

About Viragen, Inc.:

Viragen researches, develops and commercializes pharmaceutical products designed to treat a broad range of viral and malignant diseases. These protein-based drugs include: Multiferon®, a natural human alpha interferon, approved for sale in various international markets; and humanized anti-cancer monoclonal antibodies. Viragen is also pioneering the development of Avian Transgenic Technology, with the renowned Roslin Institute, as a biomanufacturing platform for the large-scale, efficient and economical production of therapeutic proteins. For more information, please visit: http://www.Viragen.com .
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