WASHINGTON

,

Feb. 17, 2021

/PRNewswire/ — The Antimicrobials Working Group (AWG) announced today the addition of UTILITY therapeutics Ltd. (UTILITY) to its coalition of companies with the mission to combat drug resistant infections and spur life-saving innovations. This new addition brings AWG’s membership to 13 antimicrobial drug companies.

UTILITY is focused on developing and commercializing antibiotics in

the United States

to address the significant threat faced by healthcare systems and patients from multi-drug resistant bacterial infections. 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.

“We are thrilled to welcome UTILITY to AWG.  UTILITY’s mission of bringing approved, safe, and efficacious products from

Europe

to the U.S. market to treat urinary tract infections is critically important in reducing the burden for patients suffering from the world’s most common infections, which are increasingly resistant to available therapies,” said

Ciara Kennedy

, Ph.D., President and Chief Executive Officer of Amplyx Pharmaceuticals and Chair of AWG. “I look forward to working with UTILITY’s team as we pursue our legislative and regulatory priorities, including the passage of the DISARM Act, that will stabilize the antimicrobial ecosystem and support innovation.”

“The cost to patients, providers, and society caused by drug resistant infections is staggering,” stated

Thomas Hadley

, UTILITY’s President and Chief Commercial Officer.  “The AWG’s focus of impacting policy change provides a pathway for new therapies to be embraced by clinicians and the U.S. healthcare system for the benefit of patients.  We are excited to join the AWG and provide our support at this critical time.”

All pharmaceutical and biotechnology companies developing new antimicrobial therapeutics and diagnostic devices are eligible for consideration of membership in AWG. If you are interested in learning more about becoming a member of AWG, please contact us

here

.

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 thirteen 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), UTILITY therapeutics Ltd., 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

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SOURCE Antimicrobials Working Group (AWG)