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The Board of Henderson Morley plc (“Henderson Morley” or
“the Company”), the AIM listed drug discovery company, is
pleased to provide the market and their shareholders with
an update detailing the current status of the Company’s
activities and its scientific pipeline.
HIGHLIGHTS
• Three licensing agreements have been signed for human
use ICVT;
• The Company is currently exploring the high-value
companion animal market, with a view to beginning field
trials when suitable candidate viruses have been
identified;
• Henderson Morley owns outright the global rights to a
vaccine platform technology known as PREPS and L-particles
and will be actively developing this technology as a;
o Cancer vaccine (immunotherapeutic to treat patients who
are already suffering with various forms of cancer)
o Vaccine against viruses (initially herpes virus
infections)
o In-vitro reagent (for use in laboratory studies)
• The Company’s pipeline offers at least 10 significant
pharmaceutical products in various stages of development,
backed up by a robust suite of intellectual property; and
• There are significant opportunities for short and long
term growth and revenue.
Executive Chairman Andrew Knight said: "We are currently
looking for ways of maximising shareholder value and
whilst we continue with the out-licensing and the
scientific development programme, the Board is actively
assessing other strategic options."
ICVT- Human use
Several key milestones have now been reached with regards
to Henderson Morley’s technology pipeline, and so far
three licensing agreements have been signed for ICVT.
Previous international collaborations, which have included
work with Doctors Birley and Conant and Professors Fiander
and Hill in a wide range of disease areas, have enabled
the Company to gain a broad based experience and a better
understanding of both the clinical and commercial
potential of ICVT. This has so far resulted in the Company
granting three licence agreements to date:
• Croma Pharma - an Austrian ophthalmic speciality
company, has taken a licence for EU and South American
territories for the treatment of viral eye infections.
Croma has completed successful Phase l trials and is
currently in discussions with licensing authorities with
regard to the further clinical development, with a view to
extending existing trial protocols. Croma remains
committed to the further clinical and commercial
development of ICVT in eye applications. Other virus
infections of the eye are also being considered as
opportunities for development (eg herpes simplex
infections in the eye).
• Amistad Pharma - a private French pharmaceutical company
signed a licence agreement in July 2006, which commits to
the further clinical and commercial development of ICVT
for the treatment of Herpes simplex infections (cold sores
and genital herpes) as well as dysplasias of the genital
tract (abnormal tissues changes caused by HPV), on a
global basis. The working arrangement with Amistad has
proven to be very sound, with a keen desire by both
parties to accelerate the clinical development of specific
formulations.
• Cutanea Life Sciences is a US based speciality
pharmaceutical company focussed entirely on the
development of dermatology products. Cutanea signed a
licence with Henderson Morley in September 2006 that will
pay over $6.75 million on the successful completion of key
milestones, and royalties to Henderson Morley once
marketing approval has been gained for certain
dermatological applications of ICVT. The licence covers
the North American trading block only, and the
intellectual property rights for the remainder of the
world are retained by Henderson Morley.
These agreements leave several key applications and
territories still available for licence, including the
North American and Japanese territories for ophthalmic
indications, and the EU and Japan for several dermatology
indications. There are also other virus infections that
fall outside of the currently licenced applications, and
these present opportunities for further development and
licensing.
Henderson Morley is currently undertaking the pre-clinical
development of injectable formulations of ICVT, working in
collaboration with Aston University department of
Pharmaceutics. It is anticipated that these studies will
enable the further development of injectable ICVT for the
treatment of certain genital infections and Orphan
diseases in children. These remain exciting market
opportunities for ICVT.
ICVT – animal health
Henderson Morley is exploring possible veterinarian
applications of ICVT. Due to the broad acting nature of
ICVT, coupled with its use of established tried and tested
drugs, it has the potential for use as a treatment of a
wide range of virus infections, in both humans and
animals. The Company is currently exploring the high-value
companion animal market, with a view to beginning field
trials when suitable candidate viruses have been
identified.
Vaccine against Koi Herpes virus
In October 2006, the Company announced that it was working
with Professor Ronald Hardy of the University of Idaho
USA, to develop a vaccine against KHV, and that it had
also appointed Professor Ronald Roberts to its scientific
advisory board. Professor Roberts is a global authority on
the pathology of fish diseases and has proven to be an
invaluable contributor to the KHV vaccine development
programme. This research is intended to demonstrate the
immunogenicity of the vaccine candidate as well as test
its prophylactic properties against live virus challenges.
The vaccine candidate uses a proprietary technology,
containing KHV antigens; however the vaccine does not
contain any live virus, so does not pose a threat to the
vaccinated fish.
The market for a successful vaccine against KHV is
considerable, as there is currently no licenced vaccine
available in the EU - with heightened interest consequent
to the virus becoming a World Organisation of Animal
Health (OIE) notifiable disease and the likely adoption of
notifiable disease status by Department for the
Environment, Food and Rural Affairs (DEFRA).
In addition the Company is now actively recruiting for a
business development consultant specialising in the global
fish health market, to take the technology through to
out-license to a third party.
Development of Henderson Morley pipeline - PREPS and
L-particles
Henderson Morley owns outright the global rights to a
vaccine platform technology known as PREPS and
L-particles. This technology was discovered by the highly
prestigious UK Government Medical Research Council’s
Glasgow virology unit.
The technology is based on the discovery that when herpes
viruses grow in culture, not only do they produce copies
of live viruses, they also produce “empty viruses”-
viruses that have a normal outer layer, but contain no DNA
or genetic material. This means that they are unable to
replicate and cause infection, but they retain their
ability to enter into cells and thus stimulate the immune
system.
In addition, it is possible to grow these viruses so that
they contain foreign proteins - for example a bacterial
protein could be incorporated into the shell of the virus,
enabling the virus to deliver this bacterial protein to
the patients’ immune system.
This offers the prospect of using these particles as
potential vaccines against a wide range of diseases - not
just human herpes viruses - as the various foreign
proteins could be incorporated into the shell of
L-particles and act as a stimulus to the immune system.
This technique could also be used to incorporate proteins
such as cancer proteins; consequently, the Company is
actively pursing the development of cancer vaccines using
L-particles and PREPS particles. To this end, the Company
is expanding its research facility and staff to facilitate
this development project and will be seeking licensing
strategies that will exploit this application.
As the PREPS and L-particles are both able to express
foreign proteins, and enter inside cells as if they were
viruses, these particles also offer the prospect of
becoming an invaluable reagent in the fast growing
biological marker market (for use in laboratories). Again
this market opportunity is being actively pursued by
Henderson Morley’s management team. This presents the
opportunity of nearer term revenues, as the development
timelines of reagents is much shorter than for
pharmaceutical products.
Summary
The Company’s pipeline offers at least 10 significant
pharmaceutical products in various stages of development,
backed up by a robust suite of intellectual property. This
presents significant opportunities for short and long term
growth and revenue. In order to maximise the commercial
potential of these opportunities and to maximise
shareholder value, the Board is actively assessing
appropriate strategic options.
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