Motif Bio PLC Motif Bio confirms receipt of FDA meeting minutes (3464P)
October 10 2019 - 1:00AM
UK Regulatory
TIDMMTFB
RNS Number : 3464P
Motif Bio PLC
10 October 2019
Motif Bio plc
("Motif Bio", or "the Company")
Motif Bio confirms receipt of FDA meeting minutes
Motif Bio plc (AIM/NASDAQ: MTFB) today announced that the
Company has received the official minutes of the Type B meeting
with the U.S. Food & Drug Administration (FDA) which took place
on September 19, 2019.
As disclosed in the announcement on September 30, 2019, the
minutes confirm that a single well-designed adequate and
well-controlled Phase III clinical trial demonstrating safety and
efficacy of iclaprim in patients with HABP, including VABP, along
with data on potential mechanisms of hepatic injury, would enable
submission of a New Drug Application for approval by FDA. It would
take several years to enroll and complete a HABP/VABP Phase III
trial and the cost is expected to be tens of millions of
dollars.
The Company continues to believe that the most efficient way to
generate future value from iclaprim is for a partner or other
entity with a lower cost of capital to complete the HABP/VABP Phase
III trial and commercialise the asset globally.
Dr. Graham Lumsden, Chief Executive Officer, said: "We now have
confirmation of what will be required to progress iclaprim towards
a potential approval. The Company is working hard to find a partner
or other entity to complete the HABP/VABP Phase III trial,
commercialise iclaprim and ensure the best outcome for shareholders
in Motif Bio."
For further information, please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive Officer)
SP Angel Corporate Finance LLP (NOMAD
& BROKER) +44 (0)20 3470 0470
David Hignell/Caroline Rowe (Corporate
Finance)
Vadim Alexandre/Abigail Wayne (Sales
& Broking)
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Lianne Cawthorne motifbio@walbrookpr.com
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
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) Motif Bio's ability to obtain
shareholder approval in connection with the Proposed Restructuring,
(ii) Motif Bio's ability to execute the Proposed Capital Raise and
Proposed Restructuring (iii) the timing, progress and the results
of clinical trials for Motif Bio's product candidates, (iv) the
timing, scope or likelihood of regulatory filings and approvals for
Motif Bio's product candidates, (v) Motif Bio's ability to
successfully commercialise its product candidates, (vi) Motif Bio's
ability to effectively market any product candidates that receive
regulatory approval, (vii) Motif Bio's commercialisation, marketing
and manufacturing capabilities and strategy, (viii) Motif Bio's
expectation regarding the safety and efficacy of its product
candidates, (ix) the potential clinical utility and benefits of
Motif Bio's product candidates, (x) Motif Bio's ability to advance
its product candidates through various stages of development,
especially through pivotal safety and efficacy trials, (xi) Motif
Bio's estimates regarding the potential market opportunity for its
product candidates, (xii) Motif Bio's ability to raise additional
capital to sustain its operations and pursue its strategy and
(xiii) 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 15, 2019, which is available on the SEC's web site,
www.sec.gov. Additionally, there can be no assurance that Motif Bio
will regain compliance with Nasdaq rules or maintain its ADS
listing on Nasdaq. Motif Bio undertakes no obligation to update or
revise any forward-looking statements.
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END
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