Motif Bio PLC Motif Bio Granted Meeting with U.S. FDA (3712T)
March 20 2019 - 2:01AM
UK Regulatory
TIDMMTFB
RNS Number : 3712T
Motif Bio PLC
20 March 2019
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulation (EU) No. 596/2014. Upon the publication
of this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Granted Meeting with U.S. FDA regarding Iclaprim
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 motifbio@walbrookpr.com
Cawthorne
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 Bio
Motif 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
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contact rns@lseg.com or visit www.rns.com.
END
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