UTILITY Receives Qualified Infectious Disease Product Designation from the U.S. FDA
London, UK. 21 May 2018 – UTILITY therapeutics Ltd (“UTILITY” or “the Company”), a pharmaceutical company focused on developing and commercialising antibiotics in the US, today announced that the U.S. Food and Drug Administration (FDA) has designated both mecillinam (injectable) and pivmecillinam (oral prodrug) as Qualified Infectious Disease Products (QIDP) for the indication of complicated urinary tract infections (cUTI).
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.
“Increasing antimicrobial resistance in the U.S. is significantly limiting the number of IV/oral treatment options available to treat cUTI caused by multidrug-resistant (MDR) pathogens,” said Paul Eckburg, MD, Acting Chief Medical Officer of UTILITY. “Mecillinam/pivmecillinam is a IV/oral carbapenem-sparing option with a good safety and efficacy profile against these MDR pathogens after decades of use outside the U.S. ― it addresses an important unmet need in the U.S.”
“Achieving a QIDP designation for both mecillinam and its oral pro-drug pivmecillinam is an exciting first step to bringing this proven antibiotic to the US market to treat patients with complicated UTI,” notes Mark Beards, Chief Executive Officer of UTILITY. “QIDP designation gives us the confidence to move forward to the next step for mecillinam in the US, to achieve an IND to start clinical development.”
On 16th May 2018 UTILITY announced an exclusive license agreement with LEO Pharma A/S on access to LEO Pharma’s complete dataset for mecillinam and pivmecillinam, with the intent of gaining approval of the products in the U.S.
For more information, please contact:
Mark Beards, CEO
+44 203 930 9665
Consilium Strategic Communications
Mary-Jane Elliott, Ivar Milligan, Chris Welsh
+44 20 3709 5700
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.
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 pro-drug pivmecillinam HCl, while the IV formulation contains the active drug mecillinam.
Pivmecillinam and mecillinam have been shown a good safety and efficacy profilefor 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 uncomplicated UTI (uUTI, ie, 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 U.S.