Recce achieves milestone with volume production
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ASX Announcement
Recce achieves milestone with volume production
of antibiotic compounds to support clinical trials
SYDNEY Australia 20 June 2017: Recce Limited (ASX: RCE), a pre-clinical-stage
pharmaceutical company engaged in the development of a new class of synthetic antibiotics,
today announced its new automated manufacturing facility in Sydney is now producing at
name-plate standard its antibiotic compounds at volumes in preparation for human clinical
trials.
The delivery of the automated manufacturing process, together with the provision of facilities
and staff for assurance of quality, is an important corporate and technical milestone as it will
ensure sufficient, timely and quality supply of the Company’s synthetic antibiotic compounds,
designed for compliance with the high standards of the US Food and Drug Administration’s
(FDA) current good laboratory practices (glp).
Executive Chairman Dr Graham Melrose at the manufacturing facility this week
Recce Executive Chairman Dr Graham Melrose said, “I am delighted with this on-schedule
milestone towards addressing the urgent global challenges of resistant superbugs”.
The automated process, which uses the latest bioreactor technology by German
Pharmaceutical equipment manufacturer Sartorius Stedim, is producing 1000ml batches of
Recce antibiotic per day or around 50 x 150ml sterile drip bags per week. This is estimated
to be enough to supply Phase I and Phase II human clinical trials.
Recce Chief Chemical Engineer Arthur Kollaras said, “Having our own new facility ensures
valuable protection against the costly delays commonly experienced by drug companies, in
their efforts to produce, refine or add to the capabilities of their product – limitations recently
emphasised by the FDA”.
Recce Quality Manager Dr Justin Ward added, “The achievement has been done at very
significant economies from alternative outside contracting – and as well, assured that the
intellectual properties and their improvements stay right here in Recce”.
Recce’s manufacturing facility at Macquarie Park in NSW and their quality laboratory in the
Technology Park of Bentley in WA have been enhanced by the purchase of specialised,
high-quality analytical equipment and each will remain totally dedicated to the production and
quality of Recce antibiotics.
About Recce Ltd
Recce Ltd (ASX: RCE) is a world-leader in synthetic-polymer compounds, particularly
against all bacteria, and viruses. The RECCE® polymers have been synthesized by an
extremely economic method. RECCE® polymers 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 the manufacture of RECCE® 327. Recce has granted patents in
Australia, United States, Europe, Japan and China – giving it legal monopolies, and potential
financial returns, from manufacture and distribution of its products in about 80% of the
world’s pharmaceutical markets for antibiotics.
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For further information please visit www.recce.com.au or contact:
Investor Relations
Peter Williams
CFO & Company Secretary
Recce Ltd
Tel: (08) 9253 9800
Media (Australia)
Media (International)
Andrew Geddes
Sue Charles/Gemma Harris
CityPR
Instinctif Partners
Tel: (02) 9267 4511
Tel: +44 (0)20 7866 7860
E: recce@instinctif.com
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