UTILITY Therapeutics Joins Antimicrobials Working Group

WASHINGTON, February 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 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

Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez