Recce - The Way Forward
Released
Released
Announcement PDF
ASX ANNOUNCEMENT
3 May 2016
Recce: The Way Forward
RECCE® antibiotic 327 has begun the FDA process towards human trials.
Recce estimates presenting its IND application to the FDA, end of Financial Year 2017
Recce Ltd (ASX: RCE) the developers of a new class of drugs targeted at antibiotic and anti-cancer
human applications, is pleased to provide an update on its activities.
The Company is focused upon obtaining approval of RECCE® antibiotic 327 to IND status by the Food &
Drug Administration (FDA) of USA.
During the process, the FDA’s examiners expect Recce to have submitted satisfactory data to them, in
three areas: EFFICACY, SAFETY, and CHEMISTRY.
Recce is now pleased to update its progress:
The Perth laboratory will produce RECCE® antibiotic 327 for tests of EFFICACY (e.g. tests in
mice against infections caused by superbugs; the tests will take about 15% of the $1,215,000
budgeted in Recce’s prospectus for “overseas animal safety/efficacy tests” - and take place over
about 6 months);
Reassuringly, within Recce’s laboratory in Perth, the preparation of RECCE® antibiotic 327 has
been repeated (including all quality assurance checks) by a technician who was not associated
with the invention;
This technician will now initiate the product’s pilot-manufacture in a laboratory in Boston, USA
where essential infrastructure, raw materials and proximity to the FDA are much more available
than in Australia; this initiation is estimated to take about 3 months – and completion of the
automated pilot-plant (for which tenders are currently being called), about a further 9 months;
Recruitment of a chemical engineer, and assistant in the USA, both by mid-June 2016; they will
ensure that the final product is produced in the pilot-plant to ‘name-plate’ standard, and continue
to refine the already highly economical manufacture process of a little over 1 hour;
The laboratory in Boston will be set-out and established at Good Manufacturing Practice (GMP)
standards – and in order to aid Recce’s progress to approval, it is proximate to the FDA;
At a compulsorily higher standard for safety (than efficacy), the Boston pilot-plant will produce
RECCE® antibiotic 327 for tests of SAFETY (consuming about 60% of the budget, over
approximately 1 year). This comprises multiple, separate, acute and chronic, detailed tests in rats
and other animals to reveal dosing and pharmacological patterns of action of RECCE® antibiotic
327;
In cooperation with Recce’s expert consultants in Boston, Recce will present and negotiate re all
data for IND approval – the “passport” for subsequent testing of RECCE® antibiotic 327 in
humans;
During this process, CHEMISTRY will also be presented to the FDA, regarding the manufacturing
of RECCE® antibiotic 327. This chemistry will include stability and formulation data, and will
consume about 10% of the budget;
Contingency will be made, equal to approximately 15% of the budget, as the FDA is quite likely to
request additional testing than already undertaken by Recce for its presentation to the FDA.
Our recent financial reports have confirmed that all financial estimates made in the prospectus have
provided a practical guide to future budgets – and hence, for Recce’s objective of presenting the IND
application to FDA, end of financial year 2017.
For further information please visit www.recce.com.au or contact:
Investor Relations
Peter Williams
CFO & Company Secretary
Recce Ltd
Tel: +61 8 9253 9800
Media Communication
Karen Oswald - karen.oswald@markocommunications.com.au
Gary Buchholz – gary@markocommunications.com.au
Marko Communications
Tel: +61 423 602 353
About Recce Ltd
Recce Ltd (ASX: RCE), led by Dr Graham Melrose, is a world-leader in synthetic-polymer antibiotics.
RECCE® antibiotics have been synthesized by an extremely simple and economic method.
RECCE® antibiotics have shown in laboratory tests that they have continued activity against bacteria
including superbugs, even after repeated use.
Recce is positioned to achieve milestones in both pre-clinical trials for FDA purposes and the
development of a pilot-plant for automated manufacture of RECCE® antibiotics.
The discovery of RECCE® antibiotics 327’s capabilities against cancer (as well as bacteria-superbugs)
has greatly increased the value of the Company’s technology, especially in view of synergism between
the anti-cancer and antibiotic properties.
Recce has granted patents in Australia, United States, Europe, Japan and China – giving it legal
monopolies and potential financial returns from manufacture and distribution in some 80% of the world’s
pharmaceutical markets.
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