Iterum Therapeutics Broadens Patent Estate for Oral Sulopenem

Rhea-AI Summary

Iterum Therapeutics (Nasdaq: ITRM) has strengthened its patent portfolio for oral sulopenem with new patents in the US and Canada. The USPTO has issued notices of allowance for two US patents: one covering the use of sulopenem etzadroxil and probenecid in treating uncomplicated urinary tract infections (expiring April 1, 2039), and another for the combination of sulopenem etzadroxil, probenecid, and valproic acid in treating specified infections (expiring March 11, 2041). Additionally, the Canadian Intellectual Property Office has issued a patent for a bilayer tablet comprising sulopenem etzadroxil and probenecid, its preparation methods, and use in treating specified diseases (expiring December 23, 2039). Iterum also has pending patent applications in other jurisdictions, including Europe and China.

Positive

• Expansion of patent protection for oral sulopenem in the US and Canada
• Extended patent expiration dates ranging from 2039 to 2041
• Potential for additional patent approvals in Europe and China

Negative

• None.

Insights

Pharmaceutical Patent Expert

The issuance of new patents for Iterum Therapeutics' oral sulopenem is a significant development in the company's intellectual property strategy. Here's why this matters:

• Extended Market Exclusivity: The new U.S. patents, set to expire in 2039 and 2041, provide Iterum with a long runway of market exclusivity for oral sulopenem. This extended protection is important in the pharmaceutical industry, where patent life directly correlates with a drug's commercial viability.
• Expanded Geographical Coverage: The addition of a Canadian patent broadens Iterum's international patent portfolio, potentially opening up new market opportunities in North America beyond the U.S.
• Diverse Patent Claims: The patents cover various aspects of oral sulopenem, including its use in treating uncomplicated urinary tract infections, combinations with other compounds and specific formulations like bilayer tablets. This multi-faceted approach strengthens Iterum's patent position against potential competitors.

However, it's important to note that while patent issuance is a positive step, it doesn't guarantee commercial success. The true value of these patents will depend on the clinical efficacy and regulatory approval of oral sulopenem, as well as its market adoption if approved. Investors should monitor Iterum's progress in clinical trials and regulatory submissions alongside these patent developments.

Biotech Market Analyst

Iterum Therapeutics' patent expansion for oral sulopenem is a strategic move that could significantly impact its market position:

• Competitive Advantage: In the crowded antibiotics market, strong patent protection can be a key differentiator. Iterum's growing patent estate may deter potential competitors and provide a more secure market position if oral sulopenem reaches commercialization.
• Valuation Impact: For a clinical-stage biotech company like Iterum, intellectual property is a important asset. These patent allowances could potentially increase the company's valuation and make it more attractive to investors or potential acquirers.
• Future Revenue Potential: The extended patent protection, particularly in the U.S. and Canada, could translate to a longer period of high-margin sales if oral sulopenem is approved. This is especially important given the rising threat of antibiotic resistance and the need for new treatment options.

However, investors should remain cautious. While patent protection is important, it's just one piece of the puzzle. Iterum still faces significant challenges, including completing clinical trials, obtaining regulatory approvals and successfully commercializing oral sulopenem in a competitive market. The company's financial position and ability to fund these activities will be important factors to watch.

DUBLIN and CHICAGO, Aug. 02, 2024 (GLOBE NEWSWIRE) -- 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 Officer
312-778-6073
IR@iterumtx.com

FAQ

What new patents has Iterum Therapeutics (ITRM) received for oral sulopenem?

Iterum Therapeutics has received notices of allowance for two US patents and one Canadian patent related to oral sulopenem. These cover the use of sulopenem etzadroxil and probenecid in treating urinary tract infections, the combination with valproic acid for specified infections, and a bilayer tablet formulation.

When do Iterum Therapeutics' (ITRM) new patents for oral sulopenem expire?

The new patents have expiration dates ranging from 2039 to 2041. Specifically, the US patent for treating urinary tract infections expires on April 1, 2039, the US patent for the combination with valproic acid expires on March 11, 2041, and the Canadian patent expires on December 23, 2039.

In which other countries is Iterum Therapeutics (ITRM) seeking patent protection for oral sulopenem?

Iterum Therapeutics has pending patent applications in several other jurisdictions, including Europe and China, for its oral sulopenem formulation and uses.