Can struggling Iterum turn the corner to an antibiotic success story? They will know in six months
More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.
The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.
Regulators will be looking at the oral formulation of sulopenem as a treatment of uncomplicated urinary tract infections (uUTI), specifically in patients with a quinolone non-susceptible pathogen.
The indication was the only one, out of three, that had yielded positive results in pivotal trials. The drug had hit the primary endpoint for the population with baseline pathogens resistant to quinolones but not the one on the patients with organisms susceptible to quinolones — still enough to provide a potential path to market, the company had reported in June.
“We estimate that there are over 6 million quinolone-resistant urinary tract infections annually in the U.S., many of which are also multi-drug resistant, and sulopenem has demonstrated superiority versus ciprofloxacin in treating these infections,” Fishman, the CEO, noted.
In other studies, though, sulopenem didn’t look as promising.
A regimen of the intravenous formulation followed by tablets failed to prove non-inferior to other established antibiotics in complicated intra-abdominal infections (cIAI) or complicated urinary tract infection (cUTI). Even though Dunne, the former CSO and current strategy advisor, suggested there were silver linings if you focus on patients with multidrug-resistant pathogens, analysts saw slim chances of approval based on the available data. Iterum’s website suggests the programs are still under development.
With only $8.7 million remaining in the banks as of Sept. 30, the company sorely needs the approval in uUTI to push the drug any further — even though in a commercial environment as unforgiving as the antibiotics space, there will be no guarantee of success.
By putting the oral prodrug forward first, Iterum will be trying to skirt the tricky hospital reimbursement and going straight for the outpatient setting.
Or it could be testing the waters for Big Pharma M&A. Fishman and Dunne, after all, had been known for their work at Durata flipping dalbavancin, which they then sold to Actavis for $675 million. The acute bacterial skin and skin structure infection treatment is now in the portfolio of AbbVie by way of its Allergan buyout.