Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
December 15 2022 - 8:00AM
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 that the United States Patent and
Trademark Office (“USPTO”) has issued Iterum a Notice of Allowance
for U.S. patent application number 16/372,075 entitled
“Combinations of Beta-Lactam Compounds and Probenecid and Uses
Thereof” that covers the use of Iterum's candidate combination of
sulopenem etzadroxil and probenecid in treating multiple diseases,
including uncomplicated urinary tract infections.
“Following on from the patent recently issued by
the USPTO directed to the composition of the bilayer tablet of
sulopenem etzadroxil and probenecid (“oral sulopenem”) and its
related uses, we are very pleased to strengthen our oral sulopenem
patent estate further with the addition of this new patent which,
when issued, will afford protection until at least 2039 and further
enhance its commercial opportunity. If approved, oral sulopenem
will be the first oral penem available in the United States,” said
Corey Fishman, Chief Executive Officer. “Enrollment in our pivotal
Phase 3 clinical trial for oral sulopenem for the treatment of
uncomplicated urinary tract infections is ongoing, and we expect to
provide an update following an interim analysis at 50% patient
enrollment.”
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 April 1, 2039, absent any extensions. The recently
issued U.S. patent for oral sulopenem entitled “Combinations of
Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires
in 2039, absent any extensions.
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 the ongoing 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 ongoing clinical trial and non-clinical development
being conducted in response to the complete response letter
received from the FDA in July 2021, availability and timing of data
from the ongoing 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 November 10, 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
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