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.
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The therapeutic protein successfully expressed, using Oxford BioMedica's
LentiVector(R) 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(R), 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 .
Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
E-mail: dcalder@viragen.com
The foregoing press announcement contains forward-looking statements that
can be identified by such terminology such as "expect," "potential,"
"suggests," "may," "should," "could" or similar expressions. Such forward-
looking statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results to be materially different from any
future results, performance or achievements expressed or implied by such
statements. In particular, management's expectations regarding future
research, development and/or commercial results could be affected by, among
other things, uncertainties relating to clinical trials and product
development; availability of future financing; unexpected regulatory delays or
government regulation generally; the Company's ability to obtain or maintain
patent and other proprietary intellectual property protection; and competition
in general. Forward-looking statements speak only as to the date they are
made. The Company does not undertake to update forward-looking statements to
reflect circumstances or events that occur after the date the forward-looking
statements are made.
SOURCE Viragen, Inc.
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http://www.viragen.com
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CONTACT:
Douglas Calder, Director of Communications,
Viragen, Inc., +1-954-233-8746, or fax, +1-954-233-1414, or
dcalder@viragen.com
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