Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
September 19 2022 - 7:30AM
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”),
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 the United States Patent and Trademark
Office has issued the Company a Notice of Allowance for U.S. patent
application number 16/972,300 entitled “Combinations of Beta-Lactam
Compounds and Probenecid and Uses Thereof” directed to the
composition of the bilayer tablet of sulopenem etzadroxil and
probenecid (“oral sulopenem”) and its related uses.
“This patent allowance provides up to 10 years
additional patent protection for our lead candidate and is a
significant milestone for Iterum in protecting the long-term
commercial potential of oral sulopenem, which, if approved, would
be the first penem available orally in the U.S. as well as the
first new oral treatment for uncomplicated urinary tract infections
in over 20 years,” said Corey Fishman, Chief Executive Officer. “We
remain focused on preparing for our planned pivotal Phase 3
clinical trial for oral sulopenem for the treatment of
uncomplicated urinary tract infections, and look forward to
commencing enrollment in the coming weeks.”
This Notice of Allowance concludes the
substantive examination of the patent application and will result
in the issuance of a U.S. patent after administrative processes are
completed. The U.S. patent scheduled to issue from this application
will expire no earlier than 2039, absent any extensions. Existing
patent protection for sulopenem etzadroxil is scheduled to expire
in 2029, subject to potential extension.
The Company’s patent portfolio also contains
pending patent applications outside the U.S. including Europe and
China, submitted following receipt of the Written Opinion of the
International Search Authority indicating that several claims
directed to the composition of the bilayer tablet of oral sulopenem
are novel and inventive.
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 potential approval of oral
sulopenem by the U.S. Food and Drug Administration (the “FDA”), the
timing and conduct of a planned Phase 3 clinical trial for oral
sulopenem and the expected issuance of a U.S. patent in connection
with the notice of allowance described above, including the timing
thereof, and the protection provided by such patent. 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 uncertainties inherent in the design,
initiation and conduct of clinical and non-clinical development,
including the planned clinical trial and non-clinical development
to be conducted in response to the complete response letter
received from the FDA in July 2021, availability and timing of data
from the planned clinical and non-clinical development, changes in
regulatory requirements or decisions of regulatory authorities, the
timing or likelihood of regulatory filings and approvals, including
the potential resubmission of the new drug application to the FDA
for oral sulopenem, 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
Iterum’s expectations regarding how far into the future Iterum’s
cash on hand will fund Iterum’s ongoing operations, the impact of
COVID-19 and related responsive measures thereto, risks and
uncertainties concerning the outcome, impact, effects and results
of Iterum’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 Iterum’s ability to complete one at all
and other factors discussed under the caption “Risk Factors” in its
Quarterly Report on Form 10- Q filed with the Securities and
Exchange Commission (the “SEC”) on August 12, 2022, 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 Matthews Chief
Financial Officer312-778-6073IR@iterumtx.com
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Apr 2023 to Apr 2024