UTILITY therapeutics Ltd. Announces Financing Led by the AMR Action Fund and FDA Acceptance of PIVYA New Drug Application with Priority Review

• UTILITY has received a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024
• FDA granted Qualified Infectious Disease Product (QIDP) designation for PIVYA in 2018, which provides an additional 5 years of data exclusivity upon approval

LONDON, UK / ACCESSWIRE / January 17, 2024 / UTILITY therapeutics Ltd., a biotechnology company focused on the development and commercialization of two European-approved antibiotics for the treatment of urinary tract infections (UTIs) in the U.S., today announced a private financing led by the AMR Action Fund. In addition, UTILITY announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for PIVYA (pivmecillinam) for the treatment of uncomplicated UTIs (uUTI).

The FDA granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024.

Pivmecillinam is a European-approved, oral prodrug of mecillinam. Pivmecillinam has a unique mechanism of action and targets penicillin binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria. UTILITY has received the FDA's qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI. 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.

"The number of safe, effective antibiotics that clinicians have at their disposal continues to dwindle in the face of rising rates of antimicrobial resistance," said AMR Action Fund CEO Henry Skinner, PhD. "Bringing pivmecillinam to the U.S. will give clinicians an important tool to help patients suffering from urinary tract infections and support efforts to enhance global access to this drug."

"We are grateful to the AMR Action Fund for its leadership and support to bring this much-needed antibiotic to the US market for uUTI," said Tom Hadley, President and CEO of UTILITY therapeutics. "We believe that PIVYA can be utilized as a first-line therapy where many of the current therapeutic options are limited due to efficacy, safety, and/or rising rates of resistance. Given there has not been a new antibiotic approved in the U.S. for the treatment of uUTI in over 20 years, the priority review by the FDA for PIVYA is an important step to providing a new option to physicians and patients as antimicrobial resistance continues to rise."

"This unique mechanism leads to favorable stability against beta-lactamase hydrolysis compared to other penicillins. In more than 30 million courses of treatment administered across Europe, oral pivmecillinam has demonstrated strong clinical cure rates with no serious adverse events observed, while maintaining a low resistance rate of approximately 5%," said Professor Morten Sommer, co-founder of UTILITY.

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, carbapenem-sparing therapy 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 provides an additional five years of market exclusivity and potentially includes Priority Review.

For additional information, please visit www.utilitytherapeutics.com.

Contact

Tom Hadley
Chief Executive Officer
Tel: +1 (973) 224-7272
info@utilitytherapeutics.com

SOURCE: Utility therapeutics Ltd.