TIDMMTFB
RNS Number : 5208J
Motif Bio PLC
03 April 2018
Motif Bio plc
("Motif Bio" or the "Company")
Motif Bio Initiates NDA Rolling Submission for Iclaprim and
Provides Business Update
Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage
biopharmaceutical company specialising in developing novel
antibiotics, today announced the initiation of a rolling submission
of a New Drug Application (NDA) to the U.S. Food & Drug
Administration (FDA) for iclaprim, a targeted, Gram-positive
investigational antibiotic, for the treatment of acute bacterial
skin and skin structure infections (ABSSSI). The NDA submission is
expected to be completed during the second quarter of 2018.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track
Designation. A candidate granted Fast Track Designation is eligible
for a rolling NDA submission, which means that a company can 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
U.S. starting from the date of first approval.
The Company has also received correspondence from the FDA that a
small business waiver has been granted for the NDA application fee
which is due upon submission of an NDA under the Prescription Drug
User Fee Act (PDUFA). As a result, Motif did not have to pay the
$2.4 million application fee for this NDA submission.
Motif Bio continues to evaluate commercialisation strategies for
bringing iclaprim, if approved, to patients in the U.S. and
elsewhere. The Company is in continuing discussions with potential
regional partners, in line with its stated strategy. For the U.S.
market, the Company's strategy is to continue to evaluate its
options, which include partnering with a revenue-generating company
or a late development-stage company in the hospital space,
employing a commercial outsourcing company or building its own
commercialisation organisation. The Company is in discussions with
several potential partners and views partnering as its preferred
strategy. However, it is noted that there can be no certainty given
as to the prospect of entering into an agreement with a partner,
nor in relation to the timing or terms on which any such agreement
may be made.
Motif Bio also announced that the Company plans to issue its
2017 full year financial results by April 10, 2018, including
filing its U.S. Annual Report on Form 20-F and its UK Annual Report
and Accounts.
Graham Lumsden, Chief Executive Officer, said: "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. 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. 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."
For further information please contact:
Motif Bio plc info@motifbio.com
Graham Lumsden (Chief
Executive Officer)
Peel Hunt LLP (NOMAD &
BROKER) + 44 (0)20 7418 8900
Dr Christopher Golden
Oliver Jackson
Northland Capital Partners
Limited (BROKER) +44 (0)203 861 6625
David Hignell/John Howes/Rob
Rees
Walbrook PR Ltd. (UK FINANCIAL
PR & IR) +44 (0) 20 7933 8780
Paul McManus/Helen Cresswell/
Lianne Cawthorne
MC Services AG (EUROPEAN
IR) +49 (0)89 210 2280
Raimund Gabriel raimund.gabriel@mc-services.eu
The Trout Group (US IR) + 1 (646) 378-2936
Meggie Purcell mpurcell@troutgroup.com
Russo Partners (US PR) +1 (858) 717-2310
David Schull david.schull@russopartnersllc.com
Travis Kruse, Ph.D. travis.kruse@russopartnersllc.com
Notes to Editors
About Iclaprim
Iclaprim is a novel investigational antibiotic that has a
different and underutilised mechanism of action compared to other
antibiotics. Iclaprim exhibits potent in vitro activity against
Gram-positive clinical isolates of many genera of staphylococci,
including methicillin-resistant Staphylococcus aureus (MRSA).
Iclaprim is rapidly bactericidal, achieving 99.9% in vitro kill
against MRSA within 4 to 6 hours of drug exposure versus 8 to 10
hours for vancomycin. To date, iclaprim has been studied in over
1,400 patients and healthy volunteers. In clinical studies iclaprim
has been administered intravenously at a fixed dose with no dosage
adjustments required in patients with renal impairment or in obese
patients. The iclaprim fixed dose may, if approved, help reduce the
resources required in hospitals since dosage adjustment by health
care professionals is avoided and overall hospital treatment costs
may be lower, especially in patients with renal impairment.
About Motif Bio
Motif Bio plc (AIM/NASDAQ: MTFB) is a clinical-stage
biopharmaceutical company engaged in the research and development
of novel antibiotics designed to be effective against serious and
life-threatening infections in hospitalised patients caused by
multi-drug resistant bacteria, including MRSA. The Company's lead
product candidate, iclaprim, is being developed for high-risk MRSA
patient populations. The first proposed indication, and near-term
commercial opportunity, is for the treatment of ABSSSI, one of the
most common bacterial infections, with 3.6 million patients
hospitalised annually in the U.S. The Company believes that
iclaprim may be suitable for first-line empiric therapy in ABSSSI
patients, especially those with renal impairment, with or without
diabetes. Unlike many standard of care antibiotics, iclaprim is
only minimally cleared via the kidneys (<2% of the administered
dose was recovered unchanged in the urine). No nephrotoxicity was
observed with iclaprim in the REVIVE Phase 3 trials and dosage
adjustment has not been required in patients with renal
impairment.
Iclaprim has an underutilised mechanism of action compared to
other antibiotics. Clinical and microbiology data indicate iclaprim
has a targeted Gram-positive spectrum of activity, low propensity
for resistance development, fixed dose administration and
favourable tolerability profile. Additionally, data support that
the inactive metabolites of iclaprim clear through the kidneys. The
Company also 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 was conducted to
study iclaprim in patients with HABP. Iclaprim has been studied in
an animal model of pulmonary MRSA infection which mimics the
pathophysiology observed in patients with cystic fibrosis. Iclaprim
has been granted orphan drug designation by the U.S. FDA for the
treatment of Staphylococcus aureus lung infections in patients with
cystic fibrosis.
Iclaprim has received Qualified Infectious Disease Product
(QIDP) designation from the FDA together with Fast Track status for
the ABSSSI and HABP indications. Upon acceptance by the FDA of a
New Drug Application (NDA) for ABSSSI or HABP, iclaprim will
receive Priority Review status and, if approved as a New Chemical
Entity, 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.
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, and (x) the factors
discussed in the section entitled "Risk Factors" in Motif Bio's
Annual Report on Form 20-F filed with the SEC on May 1, 2017, 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 company news service from the London Stock Exchange
END
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