Iterum Therapeutics Announces Collaboration with EVERSANA to Support Oral Sulopenem Launch

DUBLIN, Ireland and CHICAGO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced it has engaged EVERSANA, a leading provider of commercial services to the life science industry, to immediately initiate pre-launch activities, followed by planned commercialization services upon final agreement.

As previously announced, the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen.

Ahead of an anticipated decision by the FDA in July 2021, Iterum will utilize EVERSANA’s pre-launch activities including U.S. market access, strategic marketing, medical education, and patient services. Fully integrated commercialization services would then be expected to include clinical and commercial field teams, market access, channel management and distribution, health economics and outcomes research, compliance and medical science liaison teams, with each service optimized by data and predictive analytics. The agreement with EVERSANA builds on the strong commercial strategies the Company has developed over the last few years.

“We are very pleased to partner with EVERSANA and are confident in their ability to provide end-to-end services to ensure oral sulopenem will reach patients and their families efficiently and effectively once oral sulopenem is available for prescribing,” said Corey Fishman, Chief Executive Officer at Iterum Therapeutics. “We will be working diligently to ensure we are ready for the potential launch of oral sulopenem in the U.S. in the fourth quarter of 2021.”

“We believe in sulopenem’s value to meet a long-standing, unmet clinical need and look forward to providing Iterum’s patients with access to comprehensive support at launch using our ready-to-deploy complete commercialization infrastructure and experts,” said Jim Lang, Chief Executive Officer of EVERSANA.

The FDA has designated the NDA for priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021.

About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.