Viragen Milestone
Oxford Biomedica PLC
18 January 2006
IMMEDIATE RELEASE 18 JANUARY 2006
OXFORD BIOMEDICA AND VIRAGEN REPORT AVIAN TRANSGENIC BREAKTHROUGH
- OVA(TM) System Expresses Interferon Beta -
Oxford, UK: 18 January 2006 - Oxford BioMedica (LSE: OXB) announced today that
its partner Viragen, Inc (AMEX: VRA), along with Viragen's collaborators at the
Roslin Institute, 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)
that employs Oxford BioMedica's LentiVector(R) technology. 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 programme
to develop a preferred platform for the production of selected biopharmaceutical
proteins, having now successfully developed transgenic hens that are
synthesising 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 humanised 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 analysing 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 US 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.
-Ends-
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
Viragen, Inc: Tel: (954) 233 8746
Director of Communications, Doug Calder
City/Financial Enquiries: Tel: +44 (0)20 7466 5000
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7886 8150
Katja Stout/ Gemma Bradley
Northbank Communications
Notes to editors:
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB), the leading gene therapy company, 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 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 70 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,
Sigma-Aldrich, Viragen, MolMed and Kiadis; and has licensed technology to a
number of companies including Merck & Co, Biogen Idec and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
2. Viragen, Inc
With global operations in the USA, 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. Viragen's product portfolio includes: Multiferon(R) (multi-subtype,
natural human alpha interferon) targeting a broad range of infectious and
malignant diseases; and humanised monoclonal antibodies targeting specific
antigens over-expressed on many types of cancers. Viragen is 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 www.viragen.com
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(R) 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, which includes ProSavin(R) for Parkinson's
disease, RetinoStat(R) for retinopathy, MoNudin(R) for motor neuron disease,
SMN1-G for spinal muscular atrophy and Innurex(R) for nerve repair.
5. OVA(TM)System
Viragen holds the worldwide exclusive license to commercialise 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 gene
delivery system licensed from Oxford BioMedica, 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.
This information is provided by RNS
The company news service from the London Stock Exchange