Motif Bio plc, Release: FDA Grants Fast Track Designation For Iclaprim
Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for iclaprim intravenous (IV) to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Hospital Acquired Bacterial Pneumonia (HABP).
The FDA's Fast Track programme is designed to aid the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with Fast Track designation typically qualify for priority review, which expedites the FDA review process and market approval. Companies that receive Fast Track designation for a drug benefit from more frequent interactions with the FDA during clinical development and can submit completed sections of their New Drug Application (NDA) on a rolling basis. Graham Lumsden, Chief Executive Officer at Motif, said: "This is excellent news for Motif and comes on the back of the QIDP designation for iclaprim in late July. This Fast Track designation means we will benefit from greater FDA support and that we remain on our Phase III development timeline."
The FDA has previously designated iclaprim for the treatment of ABSSSI and HABP as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make iclaprim eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) Act. These incentives include FDA priority review, eligibility for fast-track status, and if ultimately approved by the FDA, iclaprim would 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.
Enquiries
Motif Bio plc.
Graham Lumsden (Chief Executive Officer)
Robert Bertoldi (Chief Financial Officer)
www.motifbio.com
info@motifbio.com
MC Services AG (TRADE PR)
Raimund Gabriel
+49 (0) 89 210 2280
Shaun Brown
+44 (0) 207 148 5998
Zeus Capital Partners Limited (BROKER and NOMAD)
+44 (0) 20 3709 0142
Phil Walker/ John Treacy
Dominic Wilson
Northland Capital Partners Limited (BROKER)
+44 (0) 20 7382 1100
Patrick Claridge/ David Hignell
John Howes/ Mark Treharne (Broking)
Plumtree Capital Limited (FINANCIAL ADVISOR)
+44 (0) 207 183 2493
Stephen Austin
Yellow Jersey PR Limited (FINANCIAL PR)
+44 (0) 7768 537 739
Dominic Barretto
Philip Ranger
Charles Goodwin
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.
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.
The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria.
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The FDA's Fast Track programme is designed to aid the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with Fast Track designation typically qualify for priority review, which expedites the FDA review process and market approval. Companies that receive Fast Track designation for a drug benefit from more frequent interactions with the FDA during clinical development and can submit completed sections of their New Drug Application (NDA) on a rolling basis. Graham Lumsden, Chief Executive Officer at Motif, said: "This is excellent news for Motif and comes on the back of the QIDP designation for iclaprim in late July. This Fast Track designation means we will benefit from greater FDA support and that we remain on our Phase III development timeline."
The FDA has previously designated iclaprim for the treatment of ABSSSI and HABP as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make iclaprim eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) Act. These incentives include FDA priority review, eligibility for fast-track status, and if ultimately approved by the FDA, iclaprim would 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.
Enquiries
Motif Bio plc.
Graham Lumsden (Chief Executive Officer)
Robert Bertoldi (Chief Financial Officer)
www.motifbio.com
info@motifbio.com
MC Services AG (TRADE PR)
Raimund Gabriel
+49 (0) 89 210 2280
Shaun Brown
+44 (0) 207 148 5998
Zeus Capital Partners Limited (BROKER and NOMAD)
+44 (0) 20 3709 0142
Phil Walker/ John Treacy
Dominic Wilson
Northland Capital Partners Limited (BROKER)
+44 (0) 20 7382 1100
Patrick Claridge/ David Hignell
John Howes/ Mark Treharne (Broking)
Plumtree Capital Limited (FINANCIAL ADVISOR)
+44 (0) 207 183 2493
Stephen Austin
Yellow Jersey PR Limited (FINANCIAL PR)
+44 (0) 7768 537 739
Dominic Barretto
Philip Ranger
Charles Goodwin
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.
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.
The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria.
Help employers find you! Check out all the jobs and post your resume.