UTILITY Receives Investigational New Drug Approval from US FDA

LONDON--(BUSINESS WIRE)-- UTILITY therapeutics Ltd (“UTILITY” or “the Company”), a pharmaceutical company focused on developing and commercialising antibiotics in the US, today announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) applications for mecillinam (injectable) and pivmecillinam (oral prodrug). This enables the Company to commence clinical development in the US for the treatment of complicated urinary tract infections (cUTI), and uncomplicated urinary tract infections (uUTI).

In May 2018 UTILITY announced the signature of an exclusive license agreement for the United States of America with LEO Pharma A/S on access to the complete dataset for mecillinam and pivmecillinam, which have been approved for use in Europe for over 40 years.

Both mecillinam (injectable) and pivmecillinam (oral prodrug) have been designated by the FDA as Qualified Infectious Disease Products (QIDP) for the indication of complicated urinary tract infections (cUTI) and in the case of pivmecillinam, uncomplicated urinary tract infections (uUTI).

The QIDP designation provides certain incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections, which may include priority review, and a five-year extension of market exclusivity.

“Gaining IND approval for mecillinam and its oral prodrug pivmecillinam marks an important milestone for UTILITY” said Mark Beards, Chief Executive Officer of UTILITY. “Both products have seen decades of use in the clinic and in certain markets are the most commonly used systemic antibiotics for urinary tract infections.”

“Importantly, these products continue to show low resistance and high success rates based on real world evidence. We are confident that their introduction in the US can offer a new and important treatment option for patients as well as an opportunity to reduce dependence on last resort antibiotics. We look forward to working closely with the FDA to bring these products to patients as soon as possible.”

Notes for editors:

About UTILITY therapeutics Limited

UTILITY therapeutics is focused on developing and commercialising antibiotics in the US, to address the significant threat faced by healthcare systems and patients from multi-drug resistant bacterial infections. The World Health Organisation has stated that antibiotic resistance is one of the biggest threats to global health, food security, and development today.

In May 2018 UTILITY announced the signature of an exclusive license agreement with LEO Pharma A/S on access to the complete dataset for mecillinam and pivmecillinam, for the purpose of gaining approval of the products in the US.

About mecillinam/pivmecillinam

Mecillinam is a member of the penicillin subgroup of the β-lactam antibiotic class, a widely used class of antibacterial agents for the treatment of multiple serious infection types. It is available outside the US in both IV and oral formulations; the oral formulation contains the prodrug pivmecillinam HCl, while the IV formulation contains the active drug mecillinam.

Pivmecillinam and mecillinam have shown to have good safety and efficacy profiles for oral and parenteral use, respectively, through extensive clinical usage over 40 years. Currently, pivmecillinam tablets are approved in Europe, some Asiatic countries and some African countries for the treatment of uUTI (i.e. acute uncomplicated cystitis) caused by bacteria susceptible to mecillinam.

Pivmecillinam is featured in the Infectious Diseases Society of America guidelines as a first-line therapy for uncomplicated urinary tract infections, despite it not yet being available in the US.

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