UTILITY therapeutics Ltd ("UTILITY" or "the Company"), a pharmaceutical company focused on developing and commercializing 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."