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UTILITY therapeutics announces capital raise and 2021 corporate objectives

  • Financing from new and existing investors to advance two European-approved antibiotics for the U.S. market
  • Pivmecillinam Pre-NDA meeting with the FDA scheduled for April 2021

London, February 4, 2021 — UTILITY therapeutics Ltd., a biotechnology company focused on the U.S. development and commercialization of two European-approved antibiotics for the treatment of urinary tract infections (UTI), announced the completion of a capital raise and provided corporate objectives for 2021. The use of proceeds from the capital raise includes preparation for a pre-NDA meeting with the FDA, NDA submission preparation for pivmecillinam for uncomplicated UTI, scientific engagement with key opinion leaders, and pre-commercialization planning.

“The continuing emergence of antibiotic resistance constitutes a growing threat to world health and the global economy,” stated Thomas Hadley, President and Chief Commercial Officer of UTILITY therapeutics. “Urinary tract infections are one of the world’s most common infections, are increasingly resistant to common drug treatments, and have fewer first-line therapeutic options. UTILITY’s goal is to bring safe, efficacious, approved products from Europe to the U.S. market to treat UTI patients and reduce the burden imposed by antibiotic resistance.”

Corporate Milestones for 2021
UTILITY will continue to make progress towards significant value creation in 2021 with the following anticipated milestones for pivmecillinam:

  • Pre-NDA (Type B) meeting with the FDA scheduled for April 2021
  • NDA submission preparation in 2H 2021
  • Establish commercial readiness for product launch in 2022
  • Scientific engagement with Key Opinion Leaders

About UTILITY therapeutics Ltd.

UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that is being developed for uncomplicated UTI (uUTI), and it has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, is being developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting.

UTILITY has received the FDA’s qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI, and IV mecillinam followed by oral pivmecillinam as step-down for cUTI. This therapeutic regimen allows patients to complete their treatment outside of hospital and reduces the economic burden of cUTI to both patients and payers. The FDA’s QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and it provides an additional five years of market exclusivity and potential Priority Review.

Contact
info@utilitytherapeutics.com