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21 February 2007
Progen ends the half year prepared to bolster its financial
foundation for proceeding towards PI-88 registration
Brisbane, Australia 21 February 2007. Cancer drug development
company Progen Industries (ASX: PGL, NASDAQ: PGLA), today announced the
release of its interim results for the half-year ending 31 December 2006.
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The overall loss of $10.95
million was substantially up on the previous corresponding period loss
of $2.88 million as it includes the financial impact of those transactions
booked on the termination of the Agreement for Strategic Alliance with
Medigen Biotechnology Corporation (Medigen), totaling $5.04 million.
Excluding the one-off impact of these transactions the half-year loss
amounts to $5.91 million which is within the Company’s forecasts
and consistent with the increase in expenditures on the planned Phase
III trial of PI-88 in post-resection liver cancer.
Key financial
points
- Solid cash position with cash assets of $30.03 million which includes
the private placement of $20 million, completed late December 2006,
but excluding the $5.36 million raised through the Share Purchase Plan
that closed early February 2007. The capital raised will be used to
partially fund the Phase III clinical development of PI-88 in post-resection
liver cancer.
- The results include $1.53 million in expenditures incurred on the
planned Phase III trial of PI-88 in post-resection liver cancer. These
expenditures included transferring the last steps of the PI-88 manufacturing
process to a U.S. FDA cGMP facility in readiness for the manufacture
of PI-88 API for the Phase III trial; long-term animal toxicity studies;
and fees paid to clinical and regulatory consultants.
Further expenditures will be incurred in the next six months on time-critical
items in relation to the planned Phase III trial. These are likely to
include completion of the manufacture of PI-88 API; pack and fill of PI-88
API; regulatory approvals and consultants.
Progen announced on 16 January 2007 that it had bought back its royalty
obligation from Medigen allowing Progen to develop and commercialise PI-88
as rapidly as possible and with maximum flexibility. In these half-year
results we have booked the financial impact of those transactions that
took place on the execution of this agreement. There is likely to be additional
financial impact in the next six months dependent upon when Medigen achieve
certain clinical milestones.
Half year milestones and the road ahead
The half year ending 31 December 2006 culminated with the announcement
of positive preliminary data from the Company’s Phase II clinical
trial assessing PI-88 as a liver cancer therapeutic. This was one of Progen’s
key achievements over the past six months and has given us the confidence
to proceed as rapidly as possible to a Phase III trial in this disease.
The feedback from the FDA meeting in April 2006 has laid the foundation
for Progen to take PI-88 through to a Phase III clinical development program
three years faster than anticipated. Since the Company received the official
response from the FDA regarding the End-of-Phase II meeting, Progen has
planned the international registration strategy, commenced the identification
of an international Contract Research Organisation (CRO) to assist us
in the execution of this Phase III trial, produced in-house the PI-88
Phase III starting material and engaged a US FDA cGMP facility to manufacture
the PI-88 API for the Phase III trial. The technology transfer of this
part of the manufacturing process is now complete.
Mr Justus Homburg, Progen’s CEO, commented, “While awaiting
the final Phase II data analysis, we will continue to drive as hard as
we possibly can to get the Phase III trial program underway. This has
been reflected in our increased spend in the past 6 months and our confidence
to buy back our royalty obligation to Medigen. At the same time, we are
accelerating the development of our other compounds in the discovery and
pre-clinical phases of development.”
“In the longer term, we anticipate being in a position to increase
the value of Progen via a range of opportunities including possible in-licensing
opportunities or merger and acquisition opportunities that leverage all
of our core capabilities and transform ourselves into a globally competitive
sustainable biotechnology company.”
Further
information:
About Progen: Progen
Industries Limited is an Australian based globally focused biotechnology
company committed to the discovery, development and commercialisation
of small molecule pharmaceuticals for the treatment of cancer and other
serious diseases.
Progen's three key areas of
focus are:
- Clinical Development - via a focused clinical
trial programme involving its two compounds PI-88 and PI-166.
- Drug Discovery - projects focusing on the development
of potent, selective inhibitors of carbohydrate-protein interactions,
which are implicated in many disease processes.
- Manufacturing Services – PI-88 manufacturing
development and supply for the clinical program and contract manufacturing
services.
Keywords -
Progen, cancer, PI-88
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