Iterum Therapeutics Provides Update on NDA Review
May 27 2021 - 5:00PM
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a
clinical-stage pharmaceutical company focused on developing next
generation oral and IV antibiotics to treat infections caused by
multi-drug resistant pathogens in both community and hospital
settings, today announced that the Company participated in a
late-cycle meeting with the U.S. Food and Drug Administration
(“FDA”) yesterday. During the meeting, the FDA shared issues still
under review regarding the Company’s new drug application (“NDA”)
for sulopenem etzadroxil/probenecid for the treatment of
uncomplicated urinary tract infections in patients with a quinolone
non-susceptible pathogen and the Company responded to these issues.
The FDA has determined that an Advisory Committee meeting is not
currently necessary. The review of the NDA is ongoing and the
Company was informed that the FDA continues to work toward the
PDUFA goal date of July 25, 2021.
About Iterum Therapeutics
plc
Iterum Therapeutics plc is a clinical-stage
pharmaceutical company dedicated to developing differentiated
anti-infectives aimed at combatting the global crisis of multi-drug
resistant pathogens to significantly improve the lives of people
affected by serious and life-threatening diseases around the world.
Iterum Therapeutics is advancing its first compound, sulopenem, a
novel penem anti-infective compound, in Phase 3 clinical
development with an oral formulation and IV formulation. Sulopenem
has demonstrated potent in vitro activity against a wide variety of
gram-negative, gram-positive and anaerobic bacteria resistant to
other antibiotics. Iterum Therapeutics has received Qualified
Infectious Disease Product (QIDP) and Fast Track designations for
its oral and IV formulations of sulopenem in seven indications.
Forward-Looking Statements
This press release contains forward-looking
statements. These forward-looking statements include, without
limitation, statements regarding the Company’s plans, strategies
and prospects for its business, including with respect to the
timing of review by the U.S. Food and Drug Administration of the
new drug application for oral sulopenem, including whether an
advisory committee may be necessary and the resolution of
substantive review issues raised by the FDA, and the market
potential for sulopenem. In some cases, forward-looking statements
can be identified by words such as “may,” “believes,” “intends,”
“seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,”
“assumes,” “continues,” “could,” “would,” “will,” “future,”
“potential” or the negative of these or similar terms and phrases.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the Company’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. Forward-looking
statements include all matters that are not historical facts.
Actual future results may be materially different from what is
expected due to factors largely outside the Company’s control,
including the uncertainties inherent in the initiation and conduct
of clinical trials, availability and timing of data from clinical
trials, changes in regulatory requirements or decisions of
regulatory authorities, the timing or likelihood of regulatory
filings and approvals, changes in public policy or legislation,
commercialization plans and timelines, if oral sulopenem is
approved, the actions of third-party clinical research
organizations, suppliers and manufacturers, the accuracy of the
Company’s expectations regarding how far into the future the
Company’s cash on hand will fund the Company’s ongoing operations,
the impact of COVID-19 and related responsive measures thereto,
risks and uncertainties concerning the outcome, impact, effects and
results of the Company’s evaluation of corporate, strategic,
financial and financing alternatives, including the terms, timing,
structure, value, benefits and costs of any corporate, strategic,
financial or financing alternative and the Company’s ability to
complete one at all and other factors discussed under the caption
“Risk Factors” in its Annual Report on Form 10- Q filed with the
Securities and Exchange Commission (the “SEC”) on May 14, 2021, and
other documents filed with the SEC from time to time.
Forward-looking statements represent the Company’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, the Company assumes no obligation to update these
forward-looking statements publicly, or to update the reasons
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
Investor Contact:Judy
MatthewsChief Financial Officer 312-778-6073IR@iterumtx.com
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