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pSivida
Ltd
Overview
pSivida Limited is an Australian listed public company (ASX:PSD)
that is committed to the biomedical nanotechnology sector.
It has as its core focus the development of nano-structured porous
silicon (BioSilicon™) for slow release controlled drug delivery
and brachytherapy. These applications are the core focus of our
UK operating subsidiary, pSiMedica Limited out of the multiple potential
applications for BioSilicon™ in human and animal healthcare.
pSivida’s joint venture partner in pSiMedica is the United
Kingdom Government Research and Development Agency, QinetiQ Group
plc (formerly DERA).
The management team has a powerful blend of international experience
in biotechnology commercialisation, the pharmaceutical industry,
licensing and capital markets.
Competitive
Advantages
- Unique platform nanotechnology 15 patent families, 4 granted
patents, 42 patent applications with 6 more patent families in
development.
- Core BioSilicon™ patent granted in the valuable US and
UK markets.
- A wide range of applications for the technology with near-term
licensing opportunities with specific focus on controlled drug
delivery and brachytherapy.
- Specialised drug delivery market is growing between 15-20%
per annum.
- Core focus on drug delivery due to versatility in administration
(oral, parenteral, patch and microparticals), high loading rates,
precision and flexible release times.
- Animal studies to date indicate no toxicity.
- Existing silicon manufacturing and scale-up proven.
- Silicon is abundant and inexpensive with very high purity (99.99%)
readily available.
- Manufacture of BioSilicon™ is cheap and reliable.
- Asian markets base established and growing
Technology
BioSilicon™
BioSilicon™ is a biodegradable, bioactive and biocompatible
form of silicon, which disolves in the body to become silicic acid,
the most common form of which is found in everyday foodstuffs.
BioSilicon™ retains the key semiconductor properties of silicon,
but is also machineable at a micro level, and is created through
a physical change in the silicon at the nano level, as opposed to
a chemical change. BioSilicon™ is an element, not a compound,
and the resultant porous honeycomb structure from physical nanostructuring
mimics porous membrane structures found in nature.
As a true platform nanotechnology, BioSilicon™ has multiple
potential applications in healthcare. Near term applications include
slow release drug delivery, brachytherapy (targeted in-situ cancer
therapies), conventional vaccine and DNA vaccine delivery, orthopaedics
and tissue engineering.
Potential longer-term applications for BioSilicon™ include
implant packaging, neural interfacing, biofiltration and diagnostics.
Intellectual Property
The Company’s intellectual property position is strong, with
core biomaterial patents granted in the valuable US, UK and European
markets, with 15 patent families, five more in development and more
than 42 applications pending. All patents have international applications.
Corporate
Alliances/Partnerships
Partners
Commercial
QinetiQ Group plc
United Kingdom
QinetiQ Group (formerly the Defence Evaluation and Research Agency)
is Europe’s largest research and development organisation
with annual turnover of £800 million sterling. pSivida and
pSiMedica enjoy use of the world class QinetiQ facilities and easy
access to its scientists.
Technology
pSiOncology Pte Ltd
Singapore
pSiOncology Pte Ltd incorporates a joint venture between pSiMedica
and Singapore General Hospital (SGH); the first ever in which SGH
has taken a direct equity position. It involves the licensing of
intellectual property pertaining to BioSilicon™ to explore
its potential as a platform to enable the in-situ, direct delivery
of active agents into cancerous cells; a treatment known as brachytherapy.
BioSilicon™ implants carrying radionuclides or chemotherapeutic
agents should lead to better efficacy and fewer side effects in
treating cancers whilst allowing higher doses.
PowderJect Pharmaceutical plc
USA and United Kingdom
pSiMedica has two ‘options to licence’ agreements with
PowderJect Pharmaceutical plc, which involve researching the potential
for utilisation of BioSilicon™ technology in PowderJect’s
needle-free powder injection delivery system, with a specific focus
on vaccines. PowderJect is one of the largest vaccine companies
in the world.
University of London/St Thomas Hospital
United Kingdom
The controllable degradation of BioSilicon™ in the body to
become monomeric silicic acid, as found in everyday foods, is one
of its most valuable characteristics. Work at the University of
London’s Kings College, and St Thomas Hospital, has shown
that under conditions mimicking the stomach and intestinal tract
there is substantial conversion of BioSilicon™ to monomeric
silicic acid, with the potential to be developed into an oral preventative
to combat conditions such as osteoporosis.
Nottingham University
United Kingdom
Research in the School of Biomedical Sciences at Nottingham University
is aimed at evaluating and developing biocompatible composites containing
BioSilicon™. The R&D program is developing products in
the clinical fields of tissue engineering and orthopaedics, such
as biodegradable tissue scaffolds, screws, pins and braces.
Purdue University
Indiana USA
The agreement with Purdue University expands intellectual property
in the field of derivatisation of BioSilicon™. Researchers
at Purdue have successfully coated the surface of BioSilicon™
with residues that enable the linking of almost any known organic
chemical group to BioSilicon™, further increasing the flexibility
and utility of BioSilicon™.
Implex Corporation
New Jersey USA
pSiMedica is performing a series of tests using Implex’s
Hedrocel® technology in combination with BioSilicon™,
including it’s potential to be loaded with bone growth enhancing
drugs. The successful coating of Hedrocel® with BioSilicon™
could result in the development of improved orthopaedic scaffolds
which reduce the healing time for bone breaks and fractures, decrease
muscle wastage at the point of repair and increase overall long-term
effectiveness.
Commercial – in – Confidence
United Kingdom
A materials exchange collaboration agreement involves using the
BioSilicon™ technology in vaccine delivery, including the
potential synergy between existing vaccine formulations and BioSilicon’s™
ability to enhance their immunity outcomes.
Birmingham University
United Kingdom
A collaboration whereby Birmingham’s Nano Physics Group is
exploring a number of isotopes for use as radionuclitides that may
be compatible with BioSilicon™ seeds or implants for use in
second generation Brachytherapy (in-situ cancer therapy) products.
This will serve to expand the range of products available to pSiOncology
the Singapore bracytherapy company predominately owned by pSiMedica,
currently developing a p32-BioSilicon™ implant to treat prostate
and other such similar cancers.
Finance
- Capital Raised to Date – A$11.5 million excluding monies
expended by QinetiQ on BioSilicon development prior to funding
by pSivida.
- pSivida has a 3 year A$7.5 million Equity Line of Credit Facility
from October 2002. The option to use the Facility is at pSivida’s
discretion and to date the facility remains unused.
Partnering Opportunities
The Company is seeking collaboration partners who are interested
in utilising the biomaterial BioSilicon™ to solve existing
problems in drug delivery or partners who are interested in creating
new products and applications utilising the BioSilicon.
The company will consider investment approaches from Industry partners
(including the semi-conductor and electronic industry) where it
believes there exist important synergies and value adding opportunities.
| Contact Person |
Gavin Rezos
|
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| Job Title |
Managing Director |
| Address |
Level 12, BGC Centre, 28 The Esplanade |
| City/Suburb |
Perth
WA 6000 Australia |
| Email |
gavinrezos@psivida.com.au |
| Phone |
+61 8 9226 5099 |
| Fax |
+61 8 9226 5499 |
| Website Address |
www.psivida.com.au |
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