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.
About The Antimicrobials Working Group
AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of twelve antimicrobials companies: Amplyx Pharmaceuticals, Cidara Therapeutics Inc. (NASDAQ: CDTX), Entasis Therapeutics Inc., Iterum Therapeutics Ltd. (NASDAQ: ITRM), Melinta Therapeutics Inc. (NASDAQ: MLNT), Nabriva Therapeutics US Inc. (NASDAQ: NBRV), Paratek Pharmaceuticals Inc. (NASDAQ: PRTK), Qpex Biopharma, Inc., SCYNEXIS Inc. (NASDAQ: SCYX), Summit Therapeutics plc (NASDAQ: SMMT) (AIM: SUMM), VenatoRx Pharmaceuticals, Inc., and X-Biotix Therapeutics.
For more information, visit: www.antimicrobialsworkinggroup.org
About The Conafay Group
The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.
For more information, visit: www.conafaygroup.com