Bone has a portfolio of biopharmaceutical
development projects for the treatment of bone and joint disease
(see summary table below)
An Independent Technical Expert Report was commissioned by the
Revenir Board and completed by Aoris Nova Pty Ltd, Sydney (View
report).
To complete the analysis Aoris Nova assessed
the technologies licensed in by Bone Limited, the Company’s
business strategy, the markets addressed by the technology and the Company’s
ability to access and satisfy these markets in a reasonable time.
In summary Aoris Nova concluded that:
Bone’s technologies are well founded and
have the potential to generate competitive products;
The market opportunity remains attractively large
and growing if the Company’s products demonstrate advantages
over competing drugs, which they believe Bone’s products have
the potential to do;
The technologies are the subject of several patent
applications which cover the requisite scope of Bone’s research
and development effort;
The two lead products do not contain new chemical
entities and their development and regulatory pathway is therefore
likely to be shorter and less costly than for novel drugs. These products
are relatively close to licensing out if they succeed in phase II trials
and they believe that these are appropriate and accessible target areas
for the Company; and
The previous experience of Bone’s board and
management in drug development and commercialisation provides contacts
and a breadth of expertise appropriate to the effective functioning
of a small biotechnology company.
Injectable PTH is deemed to be a major advance in the
treatment of Osteoporosis and is estimated to reach US$450
million annual sales by the year 2007.
Three pre-clinical studies have been completed by a major
global pharmaceutical company.
Australian Federal Government grant awarded to aid early
clinical development.
Ethics for Phase 1 human clinical study submitted in
Australia.
Current market for injectable or infusion anti-TNF products is
estimated at US$3bn in 2003.
New therapeutic class of potential TNF regulators has been
identified and have been moved into pre-clinical testing.
An initial in vivo pre-clinical study at the Institute
for Bone and Joint Research in Sydney, Australia, showed that
BN006 can markedly reduce the levels of TNF and reduce the
amount of weight loss induced in an animal model of TNF release.
Current sales of anti-resorptive bisphosphonates, which are
regarded as the first line of treatment for osteoporosis, total
- US$3.85bn per annum.
Drug discovery phase.
A Collaborative Testing Agreement with the Institute for
Molecular Biosciences, Brisbane, Australia, has been completed
to generate libraries of potential drug candidates to regulate
bone cells.
Studies commenced in late 2004.
.
This portfolio approach reduces overall investment
risk insofar as some products are more advanced in the development cycle
than others and the company is not totally reliant on the success of
any one particular project. Bone has a strong project pipeline that should
enable on-going development of innovative pharmaceutical products.