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 is a oral-prodrug of mecillinam and 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 USA.
Exclusive US Rights
UTILITY has exclusive US rights for the antibiotics mecillinam and pivmecillinam. Mecillinam and pivmecillinam are the most commonly used systemic antibiotics in certain markets for urinary tract infections and have demonstrated a good safety and efficacy profile for parenteral and oral 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.
Both mecillinam and pivemecillinam have been designated as Qualified Infectious Disease Products (QIDP) for the treatment of cUTI, and pivmecillinam has been designated as QIDP for uUTI. This designation provides significant incentives, such as increased market exclusivity.
UTILITY intends to submit an investigational new drug (IND) application with the FDA to start clinical development in preparation for a US new drug application (NDA) filing.