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)