Iterum Therapeutics Broadens Patent Estate for Oral Sulopenem
2024年8月2日 - 9:00PM
Iterum Therapeutics plc (Nasdaq: ITRM) (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 (USPTO) has
issued a notice allowance for two U.S. patents and the Canadian
Intellectual Property Office (CIPO) has issued a Canadian patent,
all related to sulopenem etzadroxil and probenecid (oral
sulopenem).
“We are very pleased to continue to strengthen
our oral sulopenem patent estate further with the addition of these
new patents and extending existing protection to cover Canada,”
said Corey Fishman, Chief Executive Officer.
The USPTO has issued Iterum a Notice of
Allowance for U.S. patent application number 18/065,400 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 uncomplicated
urinary tract infection. 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 USPTO has also issued Iterum a Notice of
Allowance for U.S. patent application number 17/198,335 entitled
“Combinations of Beta-Lactam Compounds, Probenecid, and Valproic
Acid and Uses Thereof” that covers the use of sulopenem etzadroxil,
probenecid, and valproic acid in treating specified infections.
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 March
11, 2041, absent any extensions.
The CIPO issued Iterum a Notice of Allowance for
Canadian patent application number 3129337 entitled “Combinations
of Beta-Lactam Compounds and Probenecid and Uses Thereof” that
covers a bilayer tablet comprising sulopenem etzadroxil and
probenecid, methods of preparing the bilayer tablet, and the use of
the bilayer tablet in treating specified diseases. This Notice of
Allowance concludes the substantive examination of the patent
application and will result in the issuance of a Canadian patent
after administrative processes are completed. The Canadian patent
scheduled to issue from this application will expire December 23,
2039, absent any extensions.
Iterum’s patent portfolio also contains pending
patent applications in a number of other jurisdictions 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 the development of its first
compound, sulopenem, a novel penem anti-infective compound, 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 submitted an NDA for oral
sulopenem for the treatment of uncomplicated urinary tract
infections in adult women, which has been accepted for review by
the U.S. Food and Drug Administration and 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 within the meaning of The Private Securities Litigation
Reform Act of 1995. These forward-looking statements include,
without limitation, statements regarding the expected issuance of
two U.S. patents and a Canadian patent in connection with the
notices of allowance described above. 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
Iterum’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
Iterum’s control, including uncertainties inherent in the design,
initiation and conduct of clinical and non-clinical development,
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
Iterum’s expectations regarding how far into the future Iterum’s
cash on hand will fund Iterum’s ongoing operations, the sufficiency
of Iterum’s cash resources and Iterum’s ability to continue as a
going concern, Iterum’s ability to regain and maintain its listing
on the Nasdaq Capital Market, risks and uncertainties concerning
the outcome, impact, effects and results of Iterum’s pursuit of
strategic alternatives, including the terms, timing, structure,
value, benefits and costs of any strategic process and Iterum’s
ability to complete one, whether on attractive terms or at all, and
other factors discussed under the caption “Risk Factors” in its
Annual Report on Form 10-Q filed with the SEC on March 31, 2024,
and other documents filed with the SEC from time to time.
Forward-looking statements represent Iterum’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, Iterum 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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