iclaprimTreatment for Skin and Structure Infection
FDA QIDP Designation for Motif’s Lead Antibiotic Candidate Iclaprim for ABSSSI
July 22, 2015 -- 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 acute bacterial skin and skin structure infections (ABSSSI).
The Company requested QIDP designation for iclaprim for two serious and life threatening infections, hospital acquired bacterial pneumonia (HABP) and ABSSSI. QIDP designation has already been confirmed for HABP.
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. With QIDP designation, iclaprim is now 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.
Graham Lumsden, CEO of Motif Bio plc, said:
“QIDP designation for iclaprim has now been confirmed for the two serious and life threatening infections that we applied for. This is an important value driver for iclaprim and another positive development for Motif and our investors. We believe that iclaprim is the first and only dihydrofolate reductase inhibitor to receive the QIDP designation.”
About Motif Bio plc
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.
Source: Motif Bio plc
Posted: July 2015
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