BRIEF—US FDA Grants Qualified Infectious Disease Product Designation for RECCE 327

Australia Recce Limited, an early stage pharmaceutical company developing a new class of synthetic antibiotics, today announced the US Food and Drug Administration has granted Qualified Infectious Disease Product (QIDP) designation for its lead compound RECCE 327.

This designation is an important achievement in the regulatory path for RECCE 327 with the FDA and has significant benefits to the business.

Recce’s application to the FDA is for RECCE 327 as a broad spectrum antibiotic, used intravenously against E.coli (Escherichia coli) and Staph (Staphylococcus aureus) bacteria in the blood, including their superbug forms.

These infections often lead to sepsis or ‘blood poisoning’ and are life threatening if untreated or if treatment isn’t effective.

In addition, if RECCE 327 completes the necessary clinical trials and is approved by the FDA, the QIDP designation will provide five years of market exclusivity, starting from the date of New Drug Application approval, extended for another five years through Hatch-Waxman exclusivity. Additional protection is provided by the company’s patents.