Motif Bio PLC US FDA meeting request and package submitted (4512F)
15 July 2019 - 4:00PM
UK Regulatory
TIDMMTFB
RNS Number : 4512F
Motif Bio PLC
15 July 2019
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Submits Meeting Request and Package to the U.S. FDA
for Iclaprim
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced that it has submitted a meeting
request and package to the U.S. Food & Drug Administration
(FDA) related to the Company's lead product candidate, iclaprim. In
the minutes from a May 3, 2019, Type A meeting, the FDA indicated
that an additional clinical trial will be required prior to
granting marketing approval of iclaprim. The Company has been
encouraged by the FDA to put forth a proposal for such a study.
Motif Bio has requested a Type B meeting with the Agency to discuss
the proposed study population and design. The Company will provide
guidance on when such a meeting will occur once FDA issues the
meeting granted letter. The FDA typically schedules a Type B
meeting within 60 days of request, although it can take longer.
Graham Lumsden, Chief Executive Officer, said: "As we take this
next step towards potential regulatory approval for iclaprim in the
U.S., I want to recognize the efforts of our dedicated team and our
clinical advisors in producing a well-considered submission package
to advance our dialogue with the FDA in an expeditious manner. As
we continue our discussions with potential U.S. commercial partners
and evaluate potential funding options for the iclaprim clinical
programme, we expect to gain greater clarity from the Agency during
the Type B meeting on the pathway forward for iclaprim."
Dr. Lumsden continued: "Our strategic goal of building long-term
shareholder value by establishing a robust pipeline of product
candidates continues to be our priority. In addition to exploring
the use of iclaprim in other disease areas through our recently
announced collaborations for cystic fibrosis and chorioretinitis,
we are actively evaluating additional in-licensing and asset
acquisition opportunities."
For further information please contact:
Motif Bio plc ir@motifbio.com
Graham Lumsden (Chief Executive
Officer)
Peel Hunt LLP (NOMAD & JOINT BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
SP ANGEL CORPORATE FINANCE LLP (JOINT
BROKER) +44 (0)20 3470 0470
David Hignell/ Vadim Alexandre /Rob
Rees
Walbrook PR Ltd. (UK FINANCIAL PR
& IR) +44 (0)20 7933 8780
Paul McManus/Lianne Cawthorne/Helen motifbio@walbrookpr.com
Cresswell
MC Services AG (EUROPEAN IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
LifeSci Advisors (U.S. IR) +1 (646) 597 6989
Bob Yedid bob@lifesciadvisors.com
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 hospitalised ABSSSI patients have renal
impairment. In February 2019, the Company received a Complete
Response Letter (CRL) related to the New Drug Application (NDA) for
iclaprim for the treatment of ABSSSI. Additional information
regarding the CRL can be found in Motif Bio's Annual Report on Form
20-F filed with the SEC on April 15, 2019. Minutes from a meeting
with the FDA to discuss the points raised in the CRL were received
in June 2019 and indicated that an additional clinical trial will
be required prior to granting marketing approval to address the
Agency's continued concerns about potential liver toxicity. The
Company was encouraged by the FDA to put forth a proposal for a
future study and submitted such a proposal for review in July 2019.
Motif Bio has requested a meeting with the Agency to discuss the
proposed study population and design.
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 pre-clinical development for this
indication.
Iclaprim 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 15, 2019, 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
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END
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