European Commission to Cover PharmaMar's Costs in Plitidepsin Case Against EMA

Key Insights

• The General Court of the European Union ruled the Aplidin case as without object after the European Commission (EC) revoked its initial decision regarding plitidepsin marketing authorization.
• The EC acknowledged a conflict of interest during plitidepsin's evaluation, involving an expert from the Scientific Advisory Group who was also a chief investigator at XNK Therapeutics, a company developing a rival product.
• The EU General Court ordered the EC to bear its own costs and to pay PharmaMar's costs in proceedings before the General Court of the EU and the Court of Justice of the EU, highlighting unfairness in the initial evaluation.

The European Commission (EC) has been ordered to cover the costs incurred by PharmaMar in its legal battle against the European Medicines Agency (EMA) regarding plitidepsin (Aplidin). This decision follows the EC's revocation of its initial refusal to grant marketing authorization for plitidepsin. The General Court of the European Union declared the case without object, removing the need for further adjudication.

The core of the dispute revolved around a conflict of interest during the EMA's evaluation of plitidepsin. According to court documents, an expert from the Scientific Advisory Group (EMA/CHMP) was simultaneously the Chief Investigator of a clinical trial at XNK Therapeutics, a now-bankrupt company developing a competing product. PharmaMar has asserted since October 2018 that this conflict of interest led to an unfair assessment of plitidepsin.

The court's order mandates that the EC bear its own legal costs and compensate PharmaMar for its expenses in proceedings before both the General Court of the EU and the Court of Justice of the EU. Other parties involved, including Germany, Estonia, the Netherlands, and the EMA itself, will bear their own costs.

Looking ahead, the EMA, at the EC's request, will re-evaluate plitidepsin for its potential use in treating multiple myeloma. PharmaMar has stated it will demand that this reassessment be conducted with complete impartiality, equality, transparency, and compliance by the EMA. Currently, there are no known claims for damages related to the initial rejection.