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Motif Bio kicks off rolling new drug application with the FDA for iclaprim

Motif Bio continues to evaluate commercialisation strategies for bringing iclaprim, if approved, to patients in the US and elsewhere

Antibiotics
The company is in continuing discussions with potential regional partners, in line with its stated strategy

Motif Bio PLC (LON:MTFB, NASDAQ:MTFB) has initiated a rolling submission of a new drug application to the US Food & Drug Administration for iclaprim.

The new drug application (NDA) for its flagship next-generation antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is expected to be completed during the second quarter of 2018.

READ: Motif Bio wants to make strongest possible submission to the US regulator as it targets second quarter for new drug application

Iclaprim has received a qualified infectious disease product (QIDP) designation from the Food & Drug Administration (FDA) together with a fast track designation, which makes a drug eligible for a rolling NDA submission, thus enabling Motif to submit completed sections of its NDA, rather than waiting until every section of the NDA has been finalised.

Upon acceptance for filing by the FDA of a complete NDA, iclaprim will receive priority review status, which will result in a review period of up to six months.

Upon NDA approval as a new chemical entity with QIDP designation, iclaprim will be eligible for 10 years of market exclusivity in the US, starting from the date of first approval.

Motif received further good news from the FDA in the form of a waiver of a US$2.4mln application fee that would normally be levied on an NDA submission.

"We are delighted to announce this major milestone of beginning our NDA submission for iclaprim in the treatment of ABSSSI by the end of the first quarter of 2018,” said Graham Lumsden, the chief executive officer of Motif.

“We remain on track to be able to complete the submission in the second quarter and will confirm when this has been done. We are also pleased to confirm the waiver for the NDA PDUFA application fee,” he added.

“We remain focused on completing the NDA submission, advancing our pre-commercialisation activities and driving discussions with potential partners as we move closer to our goal of bringing iclaprim to market for the benefit of patients," he concluded.

Motif’s joint broker, Northland Capital Partners, said: “Motif is clearly focused on completing its NDA submission as soon as practicable. It is also encouraging to see that the company did not have to pay the US$2.4 million application fee for this NDA submission, which represents significant cash savings.”

Shares in Motif were up 4.9% at 34.1p in lunchtime trading.

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Price: 0.25 GBX

AIM:MTFB
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Motif Bio announces US FDA approval deadline for its antibiotic drug

Motif Bio (LON:MTFB, NASDAQ: MTFB) CEO Graham Lumsden tells Proactive Investors the US FDA has begun the process of assessing whether the company’s next-generation antibiotic should be allowed to go on sale in the US. Motif's drug iclaprim has been granted a priority review by the...

on 08/15/2018

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