PLANTATION, Fla., Jan. 18 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) today announced that the Company's scientists, along with its
collaborators at the Roslin Institute and Oxford BioMedica plc, 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). 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 program to develop a preferred platform for the production of selected
biopharmaceutical proteins, having now successfully developed transgenic hens
that are synthesizing 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 humanized 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 analyzing 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 U.S. 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.
About the OVA(TM) System:
Viragen holds the worldwide exclusive license to commercialize 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(R) gene delivery system licensed from Oxford BioMedica plc, 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.
About Viragen, Inc.:
With global operations in the U.S., 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. Our product portfolio includes: Multiferon(R) (multi-
subtype, natural human alpha interferon) targeting a broad range of infectious
and malignant diseases; and humanized monoclonal antibodies targeting specific
antigens over-expressed on many types of cancers. We are 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: 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 "expects," "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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