U.S. Commercial Launch of ORLYNVAHTM by Q4 2025; First Oral Penem Available in the U.S.
Management to host a conference call at 4:30 p.m. ET today
DUBLIN and CHICAGO, June 11, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the "Company" or "Iterum"), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported that it entered into a Product Commercialization Agreement (the "Agreement") with EVERSANA Life Science Services, LLC ("EVERSANA") for the commercialization of the Company's approved product, ORLYNVAHTM. Pursuant to the Agreement, EVERSANA will provide sales and commercial operations services to the Company in the United States, as well as deliver marketing, logistics, channel management, regulatory, medical affairs and other services related to the commercialization of ORLYNVAHTM in the United States.
"We are extremely pleased to announce our partnership with EVERSANA with the goal of bringing ORLYNVAHTM to market in the U.S. by the fourth quarter of 2025," said Corey Fishman, Iterum's Chief Executive Officer. "By partnering with EVERSANA and leveraging their extensive commercial capabilities, we are confident we will be able to move quickly and efficiently to ensure ORLYNVAHTM is made available to prescribers and patients with limited or no oral options to handle hard-to-treat uncomplicated urinary tract infections (uUTI) in the community as soon as possible."
"We will activate the strength and depth of our fully integrated commercialization operation to successfully bring ORLYNVAHTM to market in the U.S," said Jim Lang, EVERSANA's Chief Executive Officer. "We share Iterum's vision, mission and commitment to urgently helping patients and providers get access to this much needed treatment."
Conference Call / Webcast Details
Iterum will host a conference call today, Wednesday, June 11, 2025, at 4:30 p.m. Eastern Time. The dial-in information for the call is as follows:
United States: 1 833 470 1428 / International: 1 404 975 4839
Access code: 340384
To pre-register for this call, please go to the following link: https://events.q4inc.com/attendee/719688079. The audio webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.iterumtx.com following the call.
About Urinary Tract Infections (UTIs)
UTIs are among the most common bacterial infections encountered in the community. There are approximately 15 million emergency room and office visits for symptoms of UTIs and over 40 million total prescriptions for uUTIs in the United States annually, with approximately two-thirds or 26 million of those prescriptions written for patients that are at elevated risk for treatment failure, based on market research. We estimate that approximately 30% of uUTIs in the United States are caused by quinolone non-susceptible pathogens, and approximately 1% of infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. As a result, the treatment of UTIs has become more challenging because of the development of resistance by pathogens responsible for these infections. uUTIs are infections of the bladder occurring mainly in women. Half (50%) of all women experience at least one uUTI at some point in their lives.
About Iterum Therapeutics plc
Iterum is focused on delivering 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 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 has received approval of its NDA for ORLYNVAH (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the FDA and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.
About ORLYNVAH
ORLYNVAH is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins.
About EVERSANA®
EVERSANA® is a leading independent provider of global services to the life sciences industry. EVERSANA's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. EVERSANA serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world.
Cautionary Note Regarding 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 Iterum's plans, strategies and prospects for its business, including Iterum's ability to prepare and implement commercialization plans for ORLYNVAH in partnership with EVERSANA and to bring ORLYNVAHTM to market in the U.S. by the fourth quarter of 2025, 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 risks and uncertainties concerning the outcome, impact, effects and results of Iterum's evaluation of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic alternatives, Iterum's ability to complete a strategic alternative transaction, Iterum's ability to raise sufficient capital and successfully prepare and implement commercialization plans for ORLYNVAH with its commercialization partner, EVERSANA, including Iterum's ability to, with the support of EVERSANA, build and maintain a sales force and prepare for a potential commercial launch of ORLYNVAH, the ability of shareholders and other stakeholders to realize any value or recovery as part of a wind down process if Iterum is unsuccessful at entering into or completing a strategic transaction or preparing and implementing commercialization plans for ORLYNVAH, the market opportunity for and the potential market acceptance of ORLYNVAH for uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options, Iterum's ability to continue as a going concern, uncertainties inherent in the 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, 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, Iterum's ability to maintain its listing on the Nasdaq Capital Market and other factors discussed under the caption "Risk Factors" in its Quarterly Report on Form 10-Q filed with the SEC on May 13, 2025, and other documents filed with the Securities and Exchange Commission 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
