On July 23, 2021, Iterum Therapeutics found itself on the receiving end of a complete response letter from the Food and Drug Administration. In it, the agency wrote that it had completed its review of Iterum’s New Drug Application for oral sulopenem but could not approve the application in its current form. While the CRL didn’t identify any issues related to safety or manufacturing, it called on Iterum to conduct additional clinical research.
The CRL setback hit the company hard, prompting it to cut staff and retrench, CEO and cofounder Corey Fishman recalls. But following the approval of Orlynvah by the FDA in October 2024 and its late-August launch, Iterum has beaten two larger competitors to market. New uncomplicated urinary tract infection treatments from GSK (Blujepa) and Alembic Pharmaceuticals (Pivya) are set to debut before the end of the year.
It’s easy to characterize Iterum’s post-CRL bounceback and first-place finish in the race to market as a victory for the little guy, given that the company counts fewer than 15 full-time employees among its ranks. Fishman downplays that framing, however, choosing instead to focus on unmet need and treatment paradigms.
“There was a confluence of events that made it very interesting to bring something new to that space,” he says. “It is quite large and there’s an awful lot of prescriptions each year.”
Orlynvah’s commercialization journey began in 2015, when Iterum licensed sulopenem from Pfizer. The pharma giant had contacted the nascent organization about other anti-infective assets, but Iterum recognized a need for a penem that could be taken orally; previously such drugs were administered via IV in the U.S. The company also observed growing resistance rates to older antibiotics long prescribed to treat women with uncomplicated UTIs.
“We sought the asset out. This was not someone saying, ‘Oh, let’s throw it over the transom,’” Fishman recalls.
Fishman doesn’t say it outright, but innovation within the space had diminished over the course of the last decade or two. Meanwhile, the need for antibiotics that treat UTIs continued to surge.
While 60% of women experience a UTI during their lifetime and 44% endure three or more every year, the infections are becoming harder and harder to treat. A 2024 study of around 150,000 people with uncomplicated UTIs found that 57% of initial infections were resistant to at least one class of antibiotics and 13% were resistant to three or more.
That, in a nutshell, represented both the opportunity to seize and the problem to solve. “The challenge is that there are all these old generic antibiotics, so if [providers] write one and it doesn’t work, they write another and another,” Fishman explains. “We have a drug now that they can use for the patients on the higher end of the risk spectrum… They can feel very comfortable that it will clear that infection.”
Speaking a month after Orlynvah’s launch, Fishman was optimistic about early returns and feedback. The company’s reps in the field have reported positive engagements with would-be prescribers, especially when they articulate Orlynvah’s benefits vis-a-vis aging generics.
“Like you would expect for any category that hasn’t had anything new in a very long time, a lot of folks are saying, ‘Well, I’ve done this for 20 years and I always write Cipro or Bactrim.’ That’s not a surprise,” Fishman says. “That’s part of why you have a [field] organization out saying, ‘Look, we’re not here to say we’re for every patient, but we are for these patient profiles.’”
At the same time, Fishman tempers this optimism by acknowledging the challenges facing Iterum and other life sciences companies of similar size.
“There’s a little bit more urgency. [Orlynvah] is what we’ve got. This is it,” he continues. “If you’re at a giant company that has 14 different therapy areas [and] you don’t succeed, well, that’s disappointing, but you move on, right? If [Orlynvah] doesn’t succeed, that’s a different outcome. So getting this over the line was an incredible milestone for our team.”
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