UTILITY therapeutics signs license agreement with LEO Pharma A/S for US rights to mecillinam and pivmecillinam
Mark Beards, CEO of UTILITY, stated: “Both mecillinam and its oral prodrug, pivmecillinam, have proven their worth over decades of use in the clinic for the treatment of Gram-negative infections. They are the most commonly used systemic antibiotics in certain markets for urinary tract infections, and continue to demonstrate low resistance and high success rates based on real world evidence. On this basis, we are confident that the introduction of these products in the US can offer a new and important treatment option for patients as well as an opportunity reduce dependence on last resort antibiotics.”
Fredrik Lindgren, Senior Director and Head of Global Business Development at LEO, added: “LEO Pharma is very pleased about the agreement with UTILITY. We feel confident that UTILITY will be able to successfully access the US market for mecillinam and pivmecillinam, bringing this treatment option to US patients for the first time. This agreement is an important step towards realising LEO Pharma’s 2025 strategy, which aims at helping 125 million people in 2025.”
The financial terms of the licence agreement are not being disclosed. UTILITY intends to apply to the U.S. Food and Drug Administration (FDA) for designation of both mecillinam (injectable) and pivmecillinam (oral prodrug) as Qualified Infectious Disease Products (QIDP) for the indication of complicated urinary tract infections (cUTI).
UTILITY was formed specifically to hold the exclusive US rights to mecillinam and pivmecillinam licensed from LEO Pharma A/S, and to bring these antibiotics to the US market. It was founded by biotech serial entrepreneurs Dr. Rasmus Toft-Kehler and Dr. Morten Sommer.
The Company is led by CEO Mark Beards who has more than 20 years’ experience, including both commercial and R&D roles at Abbott Laboratories and GlaxoSmithKline, strategic consultancy at McKinsey & Company, KPMG and Charles River Associates, and leadership of the European Healthcare Equity Research team at Goldman Sachs. The development program is led by Acting Chief Medical Officer Dr. Paul Eckburg, MD, who has worked in clinical research and anti-infective drug development for more than 18 years. He has been involved in the development of multiple approved anti-infective products such as anidulafungin (Eraxis®), doripenem (Doribax®), inhaled levofloxacin (Quinsair™), ceftaroline (Teflaro®), and ceftazidime-avibactam (Avycaz®).
Notes for editors:
About UTILITY therapeutics Ltd
UTILITY 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 demonstrated a good safety and efficacy profile 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 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 USA.
About LEO Pharma A/S
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the health care company has devoted decades of research and development to delivering products and solutions to people with skin conditions.
LEO Pharma is headquartered in Denmark and employs more than 5,200 people worldwide.
For more information, visit www.leo-pharma.com