Five months after hopping into the fast lane, Iterum’s oral antibiotic is hitting a roadblock. The FDA has stopped discussing labeling and postmarketing requirements thanks to “deficiencies” found in the drug’s application.
The news came in a letter from the agency that did not detail what those deficiencies were, the company said in a statement Thursday afternoon. Iterum is seeking approval for the drug, sulopenem etzadroxil/probenecid, for the treatment of uncomplicated urinary tract infections in patients for whom the quinolone class of antibiotics does not work.
The FDA granted the drug a speedy review in January and planned to decide its fate by July 25.
“The company intends to work with the FDA to understand the nature of the deficiencies and resolve them as quickly as possible,” Iterum said in the statement.
Though the notification of deficiencies “does not reflect a final decision” on the drug’s application, according to Iterum, it still isn’t a great sign, RBC Capital Markets analyst Gregory Renza said in a note.
“[We] see low likelihood for approval based on past examples of FDA deficiency letters,” Renza wrote to clients Thursday evening.
“The language and timing” of the deficiency letter, which dropped one month before a decision was due from the agency, mirror how the FDA has previously addressed therapies that later go on to be rejected, Renza said.
In other words, the same fate could be awaiting Iterum in the coming weeks.
The market seemed to agree, driving Iterum’s shares down more than 35% to $1.47 apiece on Friday.
Sulopenem is a Pfizer castoff, shelved in 2010 and offloaded to Iterum in 2015 in exchange for an upfront payment, a stake in Iterum and the chance to receive more equity, milestone payments and royalties later on. The company is also developing oral and intravenous versions of the antibiotic for complicated urinary tract infections and complicated intra-abdominal infections.
Despite the rise of drug-resistant bacteria and a clear need for new medicines, the antibiotics field has lagged behind other areas, such as cancer and rare disease. Last year, the FDA approved Shionogi’s Fetroja and Merck’s Recarbrio in new indications, but there have been very few new antibiotics approved in the last 30 years.
Big companies such as Novartis, AstraZeneca and Eli Lilly have backed away from antimicrobials research, while many small biotechs trying to fill the gap have foundered. In the span of one year, antibiotics makers Aradigm, Achaogen, Melinta and Tetraphase all filed for bankruptcy protection; all but Melinta had approved products. Investment firm Deerfield Management gave Melinta a lifeline out of bankruptcy in March 2020 and the antibiotics maker went on to acquire Tetraphase and its approved drug Xerava.
Big Pharma companies, including Johnson & Johnson, Merck and Pfizer, pooled $1 billion into a new fund that aims to see two to four new antibiotics through approval by 2030. Through the fund, dubbed the AMR Action Fund, the companies will work with charities, development banks and other organizations to ramp up antibiotics development, contributing their technical know-how as well as cash to help young biotechs advance new antibiotics. The fund recently topped up its coffers with $140 million.