May, 2013

Therakind has been awarded funding of approximately €1.9m by the European Union’s 7th Framework Programme (FP7) as the SME in part of a €6m consortium project, NeoVanc.

The NeoVanc project aims to identify an appropriate dosing regimen and develop a new age-appropriate formulation of the antibiotic, vancomycin, for the treatment of late onset bacterial sepsis in neonates and infants less than three months old.

Throughout the project, preclinical and clinical studies will be conducted in accordance with the Paediatric Investigation Plan (PIP) approved by the Paediatric Committee at the European Medicinal Agency (EMA). Such studies are aimed at defining the pharmacokinetics of this antibiotic as well as at identifying the optimal dosages for its use in the paediatric population.

In parallel, an age-appropriate formulation will be developed as the currently available product requires dilution before it is used in neonates.

Alongside Therakind, the consortium consists of St George’s Hospital Medical School (UK), French Institute of Health and Medical Research (France), University of Tartu (Estonia), Consorzio per le Valutazioni Biologiche e Farmacologiche (Italy), University of Liverpool (UK), The Children Hospital Bambino Gesù (Italy), Madrid Health Service (Spain), Aristotle University of Thessaloniki (Greece), University of Edinburgh (UK), Synapse (Spain) and the coordinating partner, PENTA Foundation (Italy).

Jackie Winslade, Therakind's Regulatory Affairs Director, commented: “We are very pleased that the NeoVanc consortium has received this award and to be collaborating with such notable organisations which are also part of the consortium. The importance of the project is demonstrated by the increased incidence of late onset neonatal sepsis (caused by Coagulase Negative Staphylococci bacteria) which has led to a marked increase in the use of vancomycin (a critically important antibiotic), now the third most common antibiotic used in European neonatal intensive care units. However, a standardised, age-appropriate dosing regimen for neonates/infants less than 3 months old has not yet been defined and there are no data about the serum concentrations needed to ensure bactericidal action on Coagulase Negative Staphylococci in humans. This lack of any firm dosage for neonates and infants has resulted in vancomycin being included in the European Medicinal Agency’s list of off-patent drugs addressing unmet therapeutic needs in children.”

The project is expected to run for 5 years and the results achieved will support the application for a Paediatric Use Marketing Authorisation (PUMA) of the formulation intended for neonates and infants under three months. Therakind will own the PUMA once granted.

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