Iclaprim is designed to be effective against multi-drug resistant bacteria.
The company requested QIDP designation for Iclaprim for two serious and life threatening infections, HABP and acute bacterial skin and skin structure infections (ABSSSI).
An additional administrative step has been requested by the FDA in order to confirm QIDP designation also for ABSSSI.
The company has already complied with the requested additional administrative step and is awaiting confirmation from FDA, expected within the next few days.
The directors, having consulted with the company’s regulatory and legal advisers, are confident that QIDP designation for ABSSSI will be granted.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), makes iclaprim eligible for certain incentives, including priority review and fast track designation.
If approved by the FDA, iclaprim will be eligible for an additional five-year extension of Hatch-Waxman exclusivity, for a total of ten years of market exclusivity, starting from the date of NDA approval.
In June this year, the company announced a £22m placing conditional upon receiving the grant of QIDP status for iclaprim not later than 24 July 2015 and upon shareholders approving the resolution at the General Meeting on 10 July 2015.