PharmaMar (MSE: PHM) wishes to express its firm disagreement with the conclusions of the General Advocate of the Court of Justice of Luxembourg published on January 12 on the Aplidin (plitidepsin) case.
In the first place, the analysis of the conflict of interest made by the Advocate General is incorrect since almost all of his analysis is based on justifying that the Karolinska Institute is not a pharmaceutical company, totally ignoring that the pharmaceutical company is a competitor with its myeloma product. multiple, CellProtect, is Swedish XNK Therapeutics AB. Here, it is worth remembering the Swedish nationalities and training at the Karolinska Institute of the four members who were key in the EMA's negative opinion on plitidepsin. Tomas Salmonson, President of the EMA's CHMP (C ommittee for Medicinal Products for Human Use), the rapporteur of the appeal, Filip Josephson, the President of the Scientific Advisory Group (SAG) evaluation, Jonas Berghand SAG multiple myeloma expert Hareth Nahi, who from 2015 to 2021 served as Senior Medical Advisor at XNK Therapeutics AB; all very inbred. Therefore, the Advocate General inexplicably confuses the pharmaceutical company XNK Therapeutics AB, which is a spin off of the Karolinska Institute, with the Karolinska Institute.
Secondly, the Advocate General argues that there are multiple drugs for the treatment of multiple myeloma, which in his opinion should have led the judgment under appeal to declare the rules on 'rival products' inapplicable in terms of conflicts of interest. However, the General Advocate ignores that with respect to a drug there are first, second, third, fourth and fifth lines of treatment, with which the competition by line is very limited, contrary to what the General Advocate says. Therefore, the General Counsel inexplicably argues that since there are many treatments for multiple myeloma there is no competition from any product. And those are the only two arguments of his to challenge the opinion of the General Court of Luxembourg.
Apart from all this, a question that has not been resolved and to which no one has given an answer is why countries like Estonia and Germany decided to appeal the decision of the General Court of Luxembourg when the legal body on which the EMA depends did not do so Without questioning the right and legitimacy of any member state to do so, it is worth asking what interests these countries have in not approving a medicine for a disease that today continues to be incurable. Even more so, when the most serious problem in conflict of interest situations is not the conflict itself, but the unacceptable bias that it can imply in people. It cannot be allowed that people with direct interests in a medicine make regulatory decisions about another rival medicine for the same indication.
Demand history
PharmaMar filed a lawsuit in October 2018 before the General Court of the European Union against the European Commission requesting the annulment of the Commission's Execution Decision, by which the marketing authorization of plitidepsin was denied as a treatment for patients with multiple myeloma .
The reason for the lawsuit referred to the strict conflict of interest verification of the experts appointed by the EMA and the correct analysis of the scientific evidence presented by PharmaMar.
In October 2020, the General Court of the European Union fully upheld PharmaMar's claim, annulling the European Commission Decision refusing the marketing of plitidepsin for the treatment of patients with multiple myeloma, as well as ordering costs to the Commission.
In 2021, Estonia and Germany appealed the decision to the Court of Justice of the EU despite the fact that the Commission decided not to do so, meaning therefore that it implicitly accepted the ruling.
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Email: pharmamar@pharmamar.com
PHARMA MAR, S.A. 
