Roughly 15% of all new-born deaths are due to sepsis. Disease progression from neonatal sepsis is rapid, requiring prompt effective parenteral antibiotic therapy. A rectal antibiotic could be successful in preventing neonatal mortality by reducing lethal delays in treating critically ill newborns, and could increase early management and adherence to treatment.
Ceftriaxone is one of three injectable antibiotics recommended for treatment of sepsis. It is currently being profiled for development as initial treatment of neonatal sepsis for home or first-level facility management in high burden neonatal mortality countries where injectable treatment of critically ill neonates is difficult or not possible. The target is a rectal formulation of ceftriaxone that delivers therapeutic drug concentrations for 10-17 hours to babies at risk of death from neonatal sepsis.
We have been provided with limited funding by the Bill & Melinda Gates Foundation to identify and transfer technology to one or more pharmaceutical companies and work with them to optimise manufacturing feasibility and produce one or more clinical batches for clinical bioavailability assessment. We invite you to submit a Letter of Intent (LOI) covering your facilities for GMP manufacture, clinical formulation development and manufacture, as well as associated analytical development and quality control services.
Please read the Request for Proposal and submit a Letter of Interest and information on your Company and its capabilities to the Committee by email to firstname.lastname@example.org by close of business 5pm GMT - 24 February 2017. The links to these documents can be found below:
University of Oxford Ceftriaxone Development Expert Committee