Motif Bio plc. (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that the U.S. Food & Drug Administration (FDA) has designated iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria, as a Qualified Infectious Diseases Product (QIDP) for hospital acquired bacterial pneumonia (HABP).
The Company requested QIDP designation for Iclaprim for two serious and life threatening infections, HABP and acute bacterial skin and skin structure infections (ABSSSI). QIDP designation has been confirmed for HABP and an additional administrative step has been requested by FDA in order to confirm QIDP designation also for ABSSSI. Motif 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 ultimately approved by the FDA, iclaprim will be eligible for an additional five-year extension of Hatch-Waxman exclusivity, for a total of 10 years of market exclusivity, starting from the date of NDA approval.
On 23 June 2015, the Company announced a £22 million placing conditional upon the Company 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. The shareholder resolutions were approved at the General Meeting.
The Company looks forward to updating the market shortly.
Enquiries
Motif Bio plc.
Graham Lumsden (Chief Executive Officer)
Robert Bertoldi (Chief Financial Officer)
www.motifbio.com
info@motifbio.com
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Notes to Editors:
Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. The Company has a lead antibiotic candidate, iclaprim, in clinical development and MTF-001, a preclinical stage programme to design a best-in-class dihydrofolate reductase inhibitor (DHFRi).
Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus ) and MDRSP (multi-drug resistant Streptococcus pneumoniae ) that have become prevalent in patients in both the community and hospital settings.
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