He General Court of the European Union issued an order declaring the case moot and the legal proceedings dismissed, after the EC revoked its initial decision to do not authorize plitidepsin for marketing.
Last July, the EC acknowledged that during the evaluation of plitidepsin, a conflict of interest arose by allowing an expert from the scientific advisory group who developed competing products and worked for the company XNK Therapeutics, which was also involved in the marketing authorization procedure. another rival product.
Since October 2018, when the initial lawsuit was filed, PharmaMar has maintained the existence of a conflict of interest such that the injustice that occurred has been demonstrated.
In this order, the EU General Court declares that the EC bears its own costs and pays the coasts of PharmaMar in proceedings before the General Court of the EU and before the Court of Justice of the EU. The other parties involved who defended the same position of the European Medicines Agency, namely Germany, Estonia, the Netherlands and the EMA itself, will bear their own costs.
The EMA, at the request of the EC, will proceed when deemed necessary to re-evaluate plitidepsin for multiple myeloma.
The company will demand that the reassessment process is carried out with absolute impartiality, fairness, transparency and compliance with EMA requirements.
