EC ordered to pay cost of PharmaMar vs EMA case

The General Court of the European Union has issued an order declaring that the Aplidin case is without object and that there is no longer any need to adjudicate on it, after the EC revoking its initial decision not to grant plitidepsin marketing authorisation. 

Last July, the EC acknowledged that during the evaluation of plitidepsin there was a conflict of interest in allowing an expert from the Scientific Advisory Group (EMA/CHMP) who was Chief Investigator of a clinical trial at the (now bankrupt) company, XNK Therapeutics was developing a rival product. 

PharmaMar has maintained since October 2018, when the initial lawsuit was filed, the existence of a conflict of interest in a manner that has demonstrated the unfairness that occurred. 

In this order, the EU General Court orders the EC to bear its own costs and to pay those of PharmaMar in proceedings before the General Court of the EU and before the Court of Justice of the EU. The other parties involved in the case, who were defending the same position as the European Medicines Agency, EMA, Germany, Estonia, the Netherlands and the EMA itself, shall bear their own costs. 

The EMA, at the request of the EC, will re-evaluate plitidepsin for Multiple Myeloma at its own discretion. PharmaMar will demand the reassessment process to be conducted with absolute impartiality, equality, transparency and compliance by the EMA. No claims for damages are known to date.