12 January 2012 - GlaxoSmithKline Plc (LON:GSK) said yesterday it was launching an appeal against a recent ruling of Argentina's top court supporting a fine issued by the local drug regulator ANMAT to the company on a vaccine trial conducted in Mendoza.

The fine issued to GSK by Argentinean National Administration of Medicines, Food and Medical Technology, or ANMAT, concerns administrative procedures for the Clinical Otitis Media and PneumoniA Study (COMPAS) in 2007 and 2008.

The UK pharmaceutical and healthcare group underscored that the fine did not question the safety of the study vaccine, Synflorix, which protects children worldwide against pneumococcal diseases. The vaccine was licensed in Europe in March 2009 and approved by ANMAT in August the same year with over 50m doses of Synflorix having been distributed in over 100 countries since 2009.

The COMPAS study, which enrolled 24,000 children, was completed in Argentina in June 2011 and is currently in the closing stage.

The company, which was accused of breachning the recruitment procedures, said that during regular monitoring of the study at six-weekly intervals it detected administrative irregularities and took prompt corrective action including reconfirming informed consent of study participants and doctors retraining. The safety of patients involved in the trials was not threatened and the Argentinean regulator agreed that the study could proceed as planned.

In a statement posted on its website, GSK refuted allegations that appeared in recent media reports relating the fine to death of children. The company said any such regretful outcomes had been independently and completely investigated and both the independent data monitoring committee and ANMAT had concluded that none of the deaths was resultant from the vaccine use.

GSK also expressed concern over allegations that treatment was delayed for some of the children if they were unwell, which clashes with the trial's guidelines. The company stressed that it carried out clinical trials adhering to high ethical and safety standards regardless of where the trial is run.