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 – called CloSed – to support the development of an age-appropriate formulation of clonidine for sedation of paediatric patients in the intensive care unit. This is the second FP7 grant awarded to Therakind as the SME partner.

Therakind is one of ten organisations which form the CloSed consortium. The University Hospital of Erlangen (Germany) has been named as the coordinating partner; the other partners consist of University College London (United Kingdom), Erasmus University Medical Centre Rotterdam (The Netherlands), Gianni Benzi Foundation (Italy), Karolinska Institute (Sweden), University of Tartu (Estonia), Charles University (Czech Republic), European Genetic Alliances Network (Belgium) and The Children Hospital Bambino Gesù (Italy).

The CloSed project’s overall objective is to obtain a Paediatric Use Marketing Authorisation (PUMA) for an age-appropriate formulation of clonidine for sedation of paediatric patients in intensive care. The project will involve the identification of an optimal dosage regimen, development of the age-appropriate formulation and conducting a phase III active-controlled clinical trial in children from birth to 18 years in accordance with a Paediatric Investigation Plan already agreed with EMA. CloSed is expected to run for five years and Therakind will own the PUMA

Susan Conroy, Therakind’s CEO, commented: “We are delighted to have received our second FP7 research grant and are looking forward to working with world-renowned experts over the next five years as we strive to achieve the project’s objectives. Clonidine is a drug used for sedation in Paediatric Intensive Care Units and is recommended by guidelines in various countries, although there is a lack of evidence regarding its safety and efficacy in this setting.  This therapeutic need is also demonstrated by the inclusion of clonidine in the European Medicinal Agency’s ‘Revised Priority List for Studies into Off-patent Medicinal Products’. The CloSed project is designed to fulfil the requirements for most ethical research in the paediatric population in order to reduce risk for patients, avoid unnecessary studies and make use of already available data, as outlined in the Paediatric Regulation. The ultimate aim is to apply for a Paediatric Use Marketing Authorisation (PUMA) and make clonidine for sedation in children available on the market”

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