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2006/OB/20
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OXFORD
BIOMEDICA EXPANDS ITS OCULAR PROGRAMME THROUGH COLLABORATION
AND INVESTMENT LED BY THE FOUNDATION FIGHTING BLINDNESS
Oxford BioMedica
(LSE:OXB), a leading gene therapy company, and The Foundation
Fighting Blindness (FFB) through its translational research
arm National Neurovision Research Institute (NNRI) announced
today that they have signed a research and collaboration agreement
to develop a portfolio of gene therapy products for the treatment
of eye diseases. This builds on the existing agreement with
FFB signed in November 2003 for the pre-clinical development
of RetinoStat®, Oxford BioMedica’s product for the
treatment of age-related macular degeneration (AMD) and for
which Oxford BioMedica expects to file an IND application in
2007. The first product in the expanded portfolio will be StarGen™
for the treatment of Stargardt disease, the most common juvenile
degenerative retinal disease. Under
the collaboration agreement and a separate share subscription
agreement, FFB and a consortium of investors will make an
undisclosed upfront payment and will also subscribe for up
to $3.9m of Oxford BioMedica ordinary shares of 1penny each
(“Ordinary Shares”) to fund the development of
StarGen. The share subscription will be made in stages and
priced at a 10% premium to the market price at the time of
investment. In return FFB and the consortium of investors
will receive a royalty on sales of StarGen.
Upon signing
of the share subscription agreement, the Company has allotted
and issued 485,185 new Ordinary Shares at 33.0 pence per share.
These new ordinary shares rank pari passu in all respects
with the existing issued Ordinary Shares. Application will
today be made to the UK Listing Authority and to the London
Stock Exchange for these 485,185 new Ordinary Shares to be
admitted to the Official List and to trading on the London
Stock Exchange's market for listed securities respectively.
Admission is expected to become effective and dealings in
the new Ordinary Shares are expected to commence on 6 October
2006.
Commenting
on the news, Oxford BioMedica’s Chief Executive, Professor
Alan Kingsman said: "We have a strong and successful
working relationship with FFB and we are delighted that they,
together with a consortium of investors, have recognised the
broad potential of Oxford BioMedica’s LentiVector®
gene delivery system for the treatment of a range of eye diseases.
FFB support will ensure that our expanded ocular programme
will move quickly towards clinical evaluation”
Gordon
Gund, Co-founder and Chairman of the Board for the Foundation
Fighting Blindness, added: “We are delighted that
this partnership with Oxford BioMedica is accelerating promising
treatments for AMD, Stargardt disease, and other retinal degenerative
diseases into clinical trials. Our collaborations with innovative
biopharmaceutical companies such as Oxford BioMedica are greatly
enhancing our ability to get preventions, treatments, and
cures out to the millions of people who need them.”
- ends -
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| Notes
| 1. |
Oxford
BioMedica plc |
| |
Oxford
BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of novel gene-based therapeutics with a
focus on 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 two candidates in
multiple Phase II trials, and a preclinical
targeted antibody therapy in collaboration
with Wyeth. A Phase III trial in renal cancer
with TroVax, the lead cancer immunotherapy
candidate, is expected to start in the second
half of 2006. In neurotherapy, the Company's
lead product is a gene therapy for Parkinson's
disease, which is expected to enter clinical
development 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,
Virxsys and Kiadis; and has licensed technology
to a number of companies including Merck
& Co, Biogen Idec and Pfizer. |
| 2. |
RetinoStat® |
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RetinoStat
is Oxford BioMedica’s novel gene-based
treatment for wet age-related macular degeneration
(AMD) and diabetic retinopathy (DR). The
product uses the LentiVector system to deliver
genes to the retina that block the formation
of new blood vessels. Oxford BioMedica has
exclusive rights to two proprietary anti-angiogenic
genes, angiostatin and endostatin, for use
in treatments of ocular diseases under a
licensing agreement with Entremed Inc. The
Company has evaluated both genes in its
RetinoStat programme. The optimised version
of the product, which will proceed to clinical
development, carries both the angiostatin
and endostatin anti-angiogenic genes and
shows significantly greater efficacy than
versions containing single genes. Preclinical
development is being conducted in collaboration
with the Institute of Ophthalmology, London,
UK, and Johns Hopkins University School
of Medicine, Baltimore, Maryland, USA, with
support from the Foundation Fighting Blindness.
The Company plans to start clinical trials
with RetinoStat in wet AMD in 2007.
|
| 3. |
Age-related
macular degeneration and other retinopathies |
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Age-related
macular degeneration (AMD) and diabetic
retinopathy (DR) are major causes of blindness
in the developed world. AMD affects an estimated
25-30 million people in the western world
and DR affects approximately 50% of all
Americans diagnosed with diabetes. It is
estimated that there are 17 million diabetics
in the USA. AMD is the most common cause
of visual loss in the elderly. DR is the
most common cause of visual loss in the
working population and is the most common
cause of acquired blindness in people under
60 in the developed world.
Both
wet AMD, the form of AMD which accounts
for 90% of all severe vision loss from the
disease, and DR are caused by aberrant growth
of leaky and disruptive blood vessels in
the retina. This growth is caused by a hyper-response
to localised regions of low oxygen arising
from compromised blood supply within the
retina. Oxford BioMedica has shown that
its LentiVector technology can target these
regions of the eye with great accuracy and
deliver anti-angiogenic proteins to treat
these diseases. Analysts’ estimates,
published in the Wall Street Journal, suggest
that sales of an effective treatment for
macular degeneration could exceed US$1 billion
per annum.
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| 4. |
The
Foundation Fighting Blindness |
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The
Foundation Fighting Blindness, Inc. (FFB)
has a mission to drive the research that will
provide preventions, treatments and cures
for people affected by retinitis pigmentosa,
macular degeneration, Usher syndrome, and
the entire spectrum of retinal degenerative
diseases. The Foundation has funded thousands
of research studies at hundreds of prominent
institutions. The Foundation funds leading-edge
research in promising areas such as genetics,
gene therapy, retinal cell transplantation,
artificial retinal implants, and pharmaceutical
and nutritional therapies. Since its inception
in 1971, the Foundation has raised over US$240
million. FFB is ranked as a “Top-Rated”
charity by the American Institute of Philanthropy
and was named one of Worth Magazine’s
“100 Best Charities.”
Further information is available at www.fightblindness.org |
| 5 |
The
National Neurovision Research Institute |
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The
mission of the National Neurovision Research
Institute (NNRI) is to accelerate the translation
of laboratory based research into clinical
trials for treatments and cures of retinal
degenerative diseases.
NNRI is a newly established non-profit entity,
a support organization of the Foundation Fighting
Blindness (FFB). The mission of the NNRI is
to accelerate the translation of laboratory
based research into clinical trials for treatments
and cures of retinal degenerative diseases.
It is a medical research institute that will
obtain support from government agencies, corporations
and private foundations. It may also receive
royalties or licensing fees from the drug
discovery processes and commercialization
of new therapies.
Further
information is available at www.nnri.info/index.htm
|
| 6 |
Stargardt disease
(STGD) |
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STGD
is the most common juvenile degenerative retinal
disease with a US and EU population of approx.
50 000 cases and an incidence of 1/10 000
(= 600 new cases /year). Autosomal recessive
STGD is a juvenile-onset macular dystrophy.
Age of onset is typically 8-12 years with
severely decreased visual acuities developing
within nine years of onset. Presentation includes
increased blindspots, and reduced ability
to adapt to dark after sunlight exposure.
Impact is confined to loss of central vision
analogous to AMD. |
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