Iterum Therapeutics PLC
NASDAQ:ITRM
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Iterum Therapeutics PLC
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Hello, everyone, and welcome to Iterum Therapeutics Call to discuss the recent approval of ORLYNVAH for treatment of uncomplicated UTIs. My name is Lydia, and I'll be your operator today. I'll now hand you over to your host, Louise Barrett, Senior Vice President of Legal Affairs, to begin.
Please go ahead.
Thank you, Lydia. Good morning, and thank you for joining today's call to discuss the recent FDA approval of ORLYNVAH. A press release with details of the approval was issued on Friday, October 25, and can be found on the Investors section of our website. We are joined this morning by our Chief Executive Officer, Corey Fishman; and our Senior Vice President and Head of Clinical Development, Dr. Steven Aronin. Corey will provide an overview of the approval generally and the market opportunity for ORLYNVAH, and Steve will provide a summary of ORLYNVAH's label.
Before we begin, I'd like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including the development, therapeutic and market potential of ORLYNVAH and our strategic process to sell, license or otherwise dispose of our rights to ORLYNVAH.
Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including, but not limited to, risks and uncertainties concerning the outcome, impact, effects and results of...
[Technical Difficulty]
Hi, everyone. Thank you for your patience. We have the speakers reconnected. So please proceed.
Thank you. We're very excited to announce that we've received FDA approval for ORLYNVAH, our oral sulopenem product on Friday for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms, E. coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. These 3 pathogens account for greater than 95% of all uncomplicated urinary tract infections.
This approval is extremely important for two reasons. First, as a potential treatment for patients with uncomplicated urinary tract infections that have limited or no other oral treatment options, ORLYNVAH has the potential to not only effectively treat these patients, but also has the opportunity to help combat the growing health crisis of rising antimicrobial resistance by offering a new treatment alternative.
Secondly, the approval marks the first U.S. approval of an oral product in the penem class of drugs, which is a very potent and safe class of drugs currently only delivered as intravenous therapy. Having an approved oral penem enables treatment for appropriate patients in the community where new effective agents are desperately needed. I'll speak more about that in a moment.
Very importantly, and before going any further, I'd like to take a moment and say a heartfelt thank you to all the patients, investigators, interim colleagues and interim consultants and vendors who participated in the development of ORLYNVAH and helped us get to this important approval milestone.
Now I'd like to spend a few more minutes sharing with you why we are so excited about the ORLYNVAH approval. The uncomplicated urinary tract infection market in the U.S. has not had a new oral treatment launched in 25 years. The leading product in the uUTI market, Nitrofurantoin, was approved in 1953, and the majority of the other oral products in the market were approved in the 1970s and 1980s. The use of these products over time and with substantial volumes being used has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching 20%, and those rates can run as high as 30% or more.
As most prescribing for uncomplicated urinary tract infections occurs empirically, this very high and oftentimes increasing resistance rate creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time. Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again create challenges for treating physicians as to their choice of agent to use. Unfortunately, since there has been almost no innovation in this market in decades, physicians have been forced to use agents that may not work as well as they would like for their patients.
With the ORLYNVAH approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available. We believe there are many patients that fall into this category, specifically elevated risk patients. We define elevated risk patients as women that fall into any of the following categories: women who are 65 or older, who have diabetes with a history of recurrent or drug-resistant infections, or women that have co-morbidities that negatively impact their immune systems. This group of patients are most at risk given their profiles and many physicians are challenged to treat these patients effectively with existing oral options that have substantial resistance as well as safety hurdles.
Another key group of patients that are in significant need of new, efficacious and safe oral treatment alternatives are the patients that have pathogens resistant to all commonly used oral antibiotics. In our REASSURE uncomplicated urinary tract infection clinical trial completed earlier this year and conducted exclusively in the U.S., across almost 1,000 patients, we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics. ORLYNVAH could play an important role in treating these patients as well.
Now I'd like to talk for a moment about the uncomplicated urinary tract market in the U.S. First, a couple of quick facts based on available research. Approximately 60% of adult women will have a urinary tract infection in their lifetime. Additionally, up to 40% of women with a history of uncomplicated urinary tract infections will have a recurrence of their infection. A total market size for uncomplicated urinary tract infections is very large, representing an estimated 40 million prescriptions annually. Based on research, we estimate that approximately 2/3 of those 40 million prescriptions represent elevated risk patients, where ORLYNVAH may be particularly valuable for patients in that category.
Now I'd like to turn the call over to Dr. Steve Aronin, Iterum's Senior Vice President and Head of Clinical Development, to speak about ORLYNVAH's label.
Good morning. I'd like to begin by echoing Corey's comments and offer my thanks to everyone involved in the development of ORLYNVAH. We really appreciate all of the time and efforts of those involved to get us to this point. Now on to the discussion of the label.
So I'll begin by saying that we're very pleased with the ORLYNVAH label as it is competitive with other oral antibiotic labels in the space while highlighting the importance of using ORLYNVAH in the appropriate patients. Consistent with all other antibiotic labels, the ORLYNVAH label has required language directed to prescribers to reduce the development of drug-resistant bacteria and maintain the effectiveness of the antibiotic. Given that ORLYNVAH will be the first oral penem antibiotic on the market, these reminders are especially important.
For instance, ORLYNVAH should only be used for patients with uncomplicated UTI, proven or strongly suspected to be caused by susceptible bacteria. When available, culture and susceptibility information should be used to select or modify antibiotic therapy, and patients should be instructed to take the ORLYNVAH exactly as directed. Similar language is found in many other antibiotic labels and will be seen as commonplace by prescribers.
Also, since ORLYNVAH will be the first oral penem antibiotic, there's additional language reminding prescribers that ORLYNVAH should be used in women who have limited or no alternative oral antibiotic options. Again, it will not be a surprise to prescribers to see this type of language in the label for the first oral penem. And as Corey just mentioned, we believe there are many patients who fall into this category.
The contraindications, warnings and precautions, adverse reactions and drug interactions sections are all unremarkable as would be expected given the results of our studies. There are no black box warnings for ORLYNVAH. And in our clinical trials, the most common adverse reactions in patients treated with ORLYNVAH were nausea and diarrhea.
Notably, ORLYNVAH is safe to take at the same time as valproic acid, which is a commonly prescribed medication for seizures. This is a nice benefit that is not seen with any of the intravenous penems. Interim has been granted a U.S. patent that covers the combination of use of beta-lactams, including sulopenem etzadroxil, probenecid and valproic acid in treating specific infections, including uncomplicated UTI.
As Corey mentioned, ORLYNVAH is approved for the treatment of all 3 of the bacteria that are responsible for more than 95% of uncomplicated UTIs, namely E. coli, Klebsiella pneumoniae and Proteus mirabilis. ORLYNVAH is dosed twice a day for 5 days, and can be taken with or without food. ORLYNVAH is safe for older patients and no dose adjustment is required for patients with renal impairment except for, of course, as contraindicated in patients who are on dialysis and with creatinine clearance less than 15.
Finally as part of ORLYNVAH's approval, there are standard postmarketing requirements that will need to be carried out over the next few years, including studies in pediatric population and surveillance studies to determine if resistance is developing to ORLYNVAH.
So in summary, ORLYNVAH's label is consistent with other antibiotic labels. It highlights the importance of antibiotic stewardship to reduce the development of resistance and maintain ORLYNVAH's effectiveness and the post marketing requirements are as expected. We believe this will put ORLYNVAH in a very strong position to be used as an important treatment alternative for appropriate patients.
Now I'll turn the call back over to Corey. Thank you.
Thanks, Steve. I'd like to highlight a few commercial elements that we believe could be important in the success of ORLYNVAH in the market, irrespective of who is commercializing the product. As mentioned previously, the market size for uncomplicated urinary tract infections, rising resistance rates to existing products, which erodes their efficacy; the relative lack of innovation in the uncomplicated urinary tract infection market for 25 years; and challenging safety profiles of existing oral products, all lead to a significant unmet need for new efficacious and safe treatment alternatives.
We believe that educating physicians about the growth of antibiotic resistance in general and more specifically, the rates of resistance to various drugs or classes of drugs in the ZIP codes where that doctor is practicing can be very valuable in helping the physicians select the appropriate antibiotic for the treatment of their patients. We also believe the opportunity for a favorable branded price point based on the unique value proposition of ORLYNVAH could further enhance the commercial opportunity.
Significant market potential for the appropriate ORLYNVAH patients across identified high writer segments could enable a targeted launch with expansion potential. A targeted distribution strategy and comprehensive patient services offering, facilitating access, affordability and prompt delivery of the therapy to the patient could optimize patient outcomes and help reinforce physician adoption. Overall, we believe ORLYNVAH has a very important place for appropriate patients in the uncomplicated urinary tract infection market.
In closing, I'd like to thank you for joining us today. We're very excited to have received approval of ORLYNVAH, and are looking forward to renewing our efforts to achieve a strategic transaction involving ORLYNVAH with the goal of maximizing value for our stakeholders.
Thank you, and have a great day.
This concludes our call. Thank you for joining. You may now disconnect your lines.