Update on meeting with US FDA
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ASX Announcement
Update on meeting with US FDA
SYDNEY, Australia, 16 May 2018: Recce Pharmaceuticals Ltd (ASX: RCE) (Recce or the
Company), developing a new class of synthetic antibiotics, announces that on the 11th of May 2018
it met with the US Food and Drug Administration (FDA) as planned, to discuss the proposed clinical
and regulatory pathway for its lead synthetic antibiotic compound RECCE® 327.
Representatives from the Company, in conjunction with its world leading FDA consultants Parexel
International, met with the FDA’s Division of Anti-Infective Products, Office of Antimicrobial Products
which will provide formal written minutes including the action required by the Company to best
facilitate its on-going antibiotic development program, within 30 days.
Recce Pharmaceuticals is seeking clinical and regulatory guidance for its lead compound RECCE®
327, which was granted Qualified Infectious Disease Product (QIDP) designation by the FDA late
last year for the treatment of bacteraemia (sepsis)
QIDP designation is part of the US Generating Antibiotic Incentives Now (GAIN) Act, labelling
RECCE® 327 for Fast Track designation, plus 10 years of market exclusivity post approval.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation of a
new class of synthetic antibiotics with broad spectrum activity designed to address the urgent global
health problem of antibiotic resistant superbugs. Its patented lead candidate known as RECCE® 327
has been developed for the treatment of blood infections and sepsis derived from E. coli and S.
aureus bacteria – including their superbug forms. Pre-clinical testing in laboratories and animal
models, in Australia and overseas has demonstrated positive results. Recce has a manufacturing
facility in Australia and is developing clinical research partners in the USA. The Company has
developed an automated process to manufacture its lead compound ahead of first-in-man clinical
trials.
For further information please visit www.recce.com.au or contact:
Investor Relations
James Graham
Executive Director
Recce Pharmaceuticals Ltd
Tel: +61 (02) 8075 4585
Media (Australia)
Andrew Geddes
CityPR
Tel: +61 (02) 9267 4511
Media (International)
Sue Charles/Gemma Harris
Instinctif Partners
Tel: +44 (0)20 7866 7860
E: recce@instinctif.com
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