Motif Bio Granted Meeting with U.S. FDA regarding Iclaprim
March 20 2019 - 3:00AM
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, announced today that the U.S. Food & Drug
Administration (FDA) has granted the Company’s request for a Type A
meeting to discuss the points raised in the Complete Response
Letter received from the FDA related to the New Drug Application
(NDA) for iclaprim for the treatment of acute bacterial skin and
skin structure infections. The meeting is scheduled to take place
on May 3, 2019.
Graham Lumsden, Chief Executive Officer
of Motif Bio, said: “We are pleased that the FDA has
granted our meeting request and that critical personnel from the
FDA have been invited to attend the upcoming meeting with our
internal and external experts. We look forward to a
collaborative meeting and to discussing with the Agency the best
way to move iclaprim towards marketing approval.”
Official meeting minutes are received from the
FDA typically within 30 days of a meeting. After this, Motif
Bio will be in a position to provide an update to the market on the
path forward for iclaprim.
As previously announced, the Company needs to
raise additional capital in the near term. A further update
regarding financing will be made in due course.
For further information please contact:
Motif Bio
plc |
ir@motifbio.com |
Graham Lumsden (Chief
Executive Officer) |
|
|
|
Peel Hunt LLP
(NOMAD & BROKER) |
+ 44 (0)20 7418 8900 |
Dr Christopher
Golden |
|
Oliver Jackson |
|
|
|
Walbrook PR
Ltd. (UK FINANCIAL PR & IR) |
+44
(0)20 7933 8780 |
Paul McManus/Helen
Cresswell/Lianne Cawthorne |
motifbio@walbrookpr.com |
|
|
MC Services AG
(EUROPEAN IR) |
+49 (0)
89 210 2280 |
Raimund Gabriel |
raimund.gabriel@mc-services.eu |
|
|
Russo Partners
(U.S. PR) |
+1
(858) 717-2310 or +1 (212) 845 4272 |
David Schull |
david.schull@russopartnersllc.com |
Note to Editors:
About Motif BioMotif Bio plc
(AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company
focused on developing novel antibiotics designed to be effective
against serious and life-threatening infections caused by
multi-drug resistant Gram-positive bacteria, including MRSA. The
Company’s lead product candidate is iclaprim. Motif Bio is seeking
approval of iclaprim from the U.S. Food & Drug Administration
(FDA) for the treatment of acute bacterial skin and skin structure
infections (ABSSSI). More than 3.6 million patients with ABSSSI are
hospitalised annually in the U.S. It is estimated that up to 26% of
hospitalized ABSSSI patients have renal impairment.
The Company also has plans to develop iclaprim
for hospital acquired bacterial pneumonia (HABP), including
ventilator associated bacterial pneumonia (VABP), as there is a
high unmet need for new therapies in this indication. A Phase
2 trial in patients with HABP has been successfully completed and a
Phase 3 trial is being planned. Additionally, iclaprim has been
granted orphan drug designation by the FDA for the treatment of
Staphylococcus aureus lung infections in patients with cystic
fibrosis and is in preclinical development for this indication.
Iclaprim has received Qualified Infectious
Disease Product (QIDP) designation from the FDA together with Fast
Track status for the ABSSSI indication. If approved for the ABSSSI
indication as a New Chemical Entity, iclaprim will be eligible for
10 years of market exclusivity in the U.S. from the date of first
approval, under the Generating Antibiotic Incentives Now Act (the
GAIN Act). In Europe, 10 years of market exclusivity is
anticipated. Motif is also building a patent estate to
provide additional protection for iclaprim and has two U.S. method
of use patents issued that will expire in 2037.
Forward-Looking Statements
This press release contains forward-looking
statements. Words such as “expect,” “believe,” “intend,” “plan,”
“continue,” “may,” “will,” “anticipate,” and similar expressions
are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks,
uncertainties and other important factors that may cause Motif
Bio’s actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Motif Bio
believes that these factors include, but are not limited to, (i)
the timing, progress and the results of clinical trials for Motif
Bio’s product candidates, (ii) the timing, scope or likelihood of
regulatory filings and approvals for Motif Bio’s product
candidates, (iii) Motif Bio’s ability to successfully commercialise
its product candidates, (iv) Motif Bio’s ability to effectively
market any product candidates that receive regulatory approval, (v)
Motif Bio’s commercialisation, marketing and manufacturing
capabilities and strategy, (vi) Motif Bio’s expectation regarding
the safety and efficacy of its product candidates, (vii) the
potential clinical utility and benefits of Motif Bio’s product
candidates, (viii) Motif Bio’s ability to advance its product
candidates through various stages of development, especially
through pivotal safety and efficacy trials, (ix) Motif Bio’s
estimates regarding the potential market opportunity for its
product candidates, (x) Motif Bio’s ability to raise additional
capital to sustain its operations and pursue its strategy and (xi)
the factors discussed in the section entitled “Risk Factors” in
Motif Bio’s Annual Report on Form 20-F filed with the SEC on April
10, 2018, which is available on the SEC’s web site, www.sec.gov.
Motif Bio undertakes no obligation to update or revise any
forward-looking statements.
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