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2005/OB/19
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OXFORD
BIOMEDICA, VIRAGEN AND THE ROSLIN INSTITUTE REPORT ACHIEVEMENT
OF AVIAN TRANSGENIC MILESTONE
Anticancer
Antibody Expressed in Chicken Eggs
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, Viragen,
Inc (AMEX: VRA) and the Roslin Institute (Scotland) today
announced a breakthrough in their collaborative project to
develop Avian Transgenic Biomanufacturing. For the first time,
the collaboration has produced a potentially therapeutic protein
selectively in the whites of eggs laid by a transgenic hen.
This technology is expected to offer a low 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 Viragen's proprietary
avian system, is a novel structure of an antibody in Viragen's
product portfolio, designed to treat 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, both of which
realise more than $2 billion in annual sales.
Analysis indicates
that the protein expression levels in the egg 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., commented on 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 synthesised 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."
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 in targeted protein production
within a transgenic animal and further demonstrates the value
of the LentiVector system in providing long-term, stable gene
expression that is amenable to tissue-specific regulation.
Viragen's achievement, together with today's announcement
of preclinical efficacy data with Innurex, Oxford BioMedica's
LentiVector-based product for nerve repair, emphasise the
progress being made and the versatility of this exceptional
gene transfer technology".
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Notes
| 1. |
Oxford
BioMedica |
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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 trials in
early 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 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.
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| 2. |
Viragen,
Inc |
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Viragen researches, develops and commercialises
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
www.viragen.com.
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| 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
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. Current
licensees of the technology include Merck
& Co and Biogen Idec.
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| 5. |
Avian
Transgenic Technology |
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Viragen holds the worldwide exclusive license
to commercialise 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 Oxford BioMedica’s
LentiVector system, 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 Programme”, designed
to support significant technological advances
being made in Scotland.
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further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel: +44 (0)1865 783 000 |
| City/Financial
Enquiries
Lisa
Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000
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Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout, Ashley
Lilly
College Hill - Life Sciences |
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+44 (0)20 7886 8150 |
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