AMDINOCILLIN PIVOXIL

“Our goal has always been to get this product to market,” Iterum Therapeutics CEO Corey Fishman said. “And whether that was us, whether that was a partnership or someone else, that’s still our goal.” With three new antibiotics set to shake up the stagnant treatment landscape for uncomplicated urinary tract infections (uUTIs) in the U.S., Dublin-based Iterum Therapeutics has made it to market first, edging out generics juggernaut Alembic Pharmaceuticals and British Big Pharma GSK.Wednesday, Iterum officially launched Orlynvah, which secured FDA approval last October to treat uUTIs caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women for whom other oral treatment options are limited or unavailable.Aside from being the first new branded uUTI treatment to launch in the U.S. in nearly three decades, Orlynvah is the only oral penem antibiotic to have received a green light from the FDA.The introduction of Orlynvah into the market—plus the looming debut of new treatments from Alembic and GSK—comes at a crucial time as the rising tide of antimicrobial resistance erodes the potency of antibiotics long-used to fight infections in the U.S.“We’re talking about a space that hasn’t seen any new products on the branded side in over 25 years,” Iterum CEO Corey Fishman said in a recent interview with Fierce Pharma.Without innovation on that front, resistance to the current slate of antibiotic treatments has risen, the chief executive explained: “Resistance keeps going up, efficacies are going down, and you’ve got an enormous market that is really struggling to find new and effective treatments.” Iterum figures Orlynvah has a major role to play in uUTI treatment given its distinction as the U.S.’ only oral penem antibiotic. Penem antibiotics have long been considered the “go-to class of drugs for serious infections,” but, up until now, have traditionally been infused in a hospital, Fishman noted.Iterum has singled out a total uUTI treatment market of roughly 40 million prescriptions per year in the U.S., but the company will focus its attention on “at-risk patients” specifically—a category that includes those with comorbidities like diabetes or heart failure, are older or have compromised immune systems and those who live with recurrent infections, according to the company’s CEO.That works out to about 26 million annual prescriptions that could be addressed with Orlynvah, Fishman said.“We know with those folks, if you don’t treat them well the first time, you can have some really negative outcomes,” he said. Anatomy of a launch Upon winning approval last October, Iterum said it would “renew” efforts to pin down a “strategic transaction” involving Orlynvah.But none of the options presented to Iterum or its board were to their satisfaction, prompting the company to take commercialization into its own hands, Fishman explained. At the same time, the CEO caveated that transactions and business development deals are “never off the table.”“Our goal has always been to get this product to market,” he said, “And whether that was us, whether that was a partnership or someone else, that’s still our goal.”Nevertheless, Iterum is a small company boasting just nine employees, Fishman pointed out. In turn, the biotech simply didn’t have the resources to prepare for Orlynvah’s launch years in advance.So, after winning FDA approval in late October, Iterum kicked off a “dual-track approach” to bring Orlynvah to market, scrutinizing potential deals while simultaneously prepping for a launch of its own, Fishman said.Given Iterum’s size, the company has now partnered with Eversana Life Sciences Services to help carry the launch through. The company has also teamed up with a specialty pharmacy to help with distribution, Fishman explained.As for where Iterum will aim its marketing muscle, the company has targeted regions along three lines: rate of antibiotic resistance in the area, the number of high-prescribing doctors for uUTIs there and the region’s projected market access rates.“We’re going to start with 20 geographies in phase one of our launch, and that’s going to represent roughly 2,300 physician targets,” Fishman explained. Those geographies are “really clustered around seven states,” he added, pointing to New York, New Jersey, Connecticut, Pennsylvania, Texas, Florida and Georgia.During that initial phase, Iterum’s primary goal is to “generate an amount of demand that shows that this is a product that has a real place in the market,” Fishman said.“With additional financing over time, we’ll be able to potentially expand and get into further territories and grow the organization that way,” he added.The company is setting the list price for Orlynvah at a range between $1,400 and $4,700 per prescription, which doesn’t factor in discounts or rebates through insurance. However, eligible patients will be able to pay just $25 for an Orlynvah prescription through an Iterum copay savings program, Fishman noted.The company aimed to price its drug along the same lines as other branded oral antibiotics that have debuted in the past half-decade or so, Fishman said. Orlynvah’s price also reflects the antibiotic’s role as a treatment for an acute infection rather than something that is prescribed regularly, he added. Competition looms With its launch Wednesday, Orlynvah now has some lead to feel out the market before the nearing U.S. launches of two other novel uUTI agents from GSK and Alembic Pharmaceuticals. GSK plans to launch its first-in-class uUTI treatment Blujepa—approved in late March—in the second half of 2025, while Alembic has said it expects its oral treatment Pivya to be available in the U.S. by the fourth quarter.Alembic picked up Pivya, also known as pivmecillinam, when it acquired the small company Utility Therapeutics in July. The FDA greenlighted pivmecillinam for the first time in April 2024, though the antibiotic has been available in Europe for more than 40 years.In the meantime, Iterum isn’t sweating the competition, with Fishman speculating that “there is plenty of space to be able to coexist completely.”It’s also worth pointing out that the vast majority of the uUTI treatment market is and will likely continue to be dominated by generics. In turn, Iterum would be “quite happy if we captured 5% of the market, well north of a million prescriptions at peak,” Fishman said. The entrance of multiple new players might also shine a spotlight on the issue of antibiotic resistance more broadly, he pointed out.“By having these new drugs that don’t have any resistances to start, if you treat the right bug and the right patient with the right dose at the right time, [you’re] unlikely to get much resistance for a very, very long time,” Fishman explained. 

Pivya has been proven safe in three studies. Credit: Summit Art Creations/Shutterstock. Alembic Pharmaceuticals has acquired UTILITY therapeutics, expanding its portfolio with the addition of Pivya (pivmecillinam 185 mg tablets), a penicillin class antibacterial for treating uncomplicated urinary tract infections (uUTIs). In April 2024, Pivya received approval from the US Food and Drug Administration (FDA) for uUTIs. uUTI is caused by strains of Proteus mirabilis, Escherichia coli and Staphylococcus saprophyticus. The drug’s unique mechanism targets gram-negative bacteria cell walls effectively. Alembic Pharmaceuticals president Craig Salmon stated: “The acquisition of UTILITY and the commercialisation of Pivya are important steps in Alembic’s strategic goal to provide branded pharmaceutical products to the US healthcare market. “Pivya will further enhance Alembic’s ability to build long-term value by combining global research, regulatory and manufacturing strengths with a sharpened focus on speciality segments. Alembic plans to make Pivya available in the US in the fourth quarter of 2025.” Pivya has been proven safe in three studies. The most common adverse reactions are diarrhoea, nausea, vulvovaginal candidiasis, genital pruritus and headache. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence UTILITY Therapeutics co-founder and board member Dr Morten Sommer stated: “I am excited to see Alembic drive the commercialisation of Pivya, which is uniquely positioned to help millions of American women with urinary tract infections. “With a novel mechanism of action, not previously deployed in the US, Pivya can become a cornerstone of the treatment of urinary tract infections based on its first-line positioning in the Infectious Disease Society of America treatment guidelines. On behalf of the co-founders, investors and board of directors, we are excited that Pivya will help address the societal impact of the uUTI disease burden in women.” Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now