PharmaMar maintains that there was a conflict of interest in the Aplidin® (plitidepsin) case

PharmaMar (MSE:PHM) wishes to express its firm disagreement with the conclusions of the Advocate General of the Court of Justice of Luxembourg, published on January 12th in the Aplidin® (plitidepsin) case. Firstly, the Advocate General’s conflict of interest analysis is incorrect because almost all of his analysis is based on the justification that the Karolinska Institute is not a pharmaceutical company, totally ignoring that the competing pharmaceutical company with its multiple myeloma product, CellProtect, is the Swedish company XNK Therapeutics AB. Here, it is worth recalling the Swedish nationalities and Karolinska Institute training of the four members, who were key to the EMA’s negative opinion on plitidepsin. Tomas Salmonson, chair of the EMA’s CHMP (Committee for Medicinal Products for Human Use), the rapporteur of the appeal, Filip Josephson, the chair of the Scientific Advisory Group (SAG) assessment, Jonas Bergh, and SAG’s multiple myeloma expert, Hareth Nahi, who between 2015 and 2021 served as Senior Medical Advisor to XNK Therapeutics AB; all very inherent. Thus, 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 view should have led the judgment under appeal to declare the “rival products” rules on conflicts of interest inapplicable. However, the Advocate General ignores that with respect to a drug there are first, second, third, fourth and fifth lines of treatment, so that competition per line is very limited, contrary to what the Advocate General says. Therefore, the Advocate General inexplicably argues that since there are many treatments for multiple myeloma there is no competition from any product. Those are his only two arguments for challenging the opinion of the General Court in Luxembourg. Apart from all this, an unresolved question that no one has answered is why countries such as Estonia and Germany decided to appeal the decision of the General Court in 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 drug for a disease that is still incurable today. Even more so, when the most serious problem of conflict of interest situations is not the conflict itself, but the inadmissible bias that it can imply in people. It is unacceptable for people with direct interests in a drug to make regulatory decisions about another rival drug for the same indication. History of the lawsuit PharmaMar filed an action in October 2018 before the General Court of the European Union against the European Commission seeking the annulment of the Commission’s Implementing Decision, by which it denied marketing authorization for plitidepsin as a treatment for patients with multiple myeloma. PharmaMar filed an action in October 2018 before the General Court of the European Union against the European Commission seeking the annulment of the Commission’s Implementing Decision, by which it denied marketing authorization for plitidepsin as a treatment for patients with multiple myeloma. The reason for the lawsuit related to the strict conflict-of-interest checks carried out by 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 upheld PharmaMar’s claim in full, annulling the European Commission’s decision to refuse to market plitidepsin for the treatment of patients with multiple myeloma, and ordered the Commission to pay the costs. In 2021, Estonia and Germany appealed the decision to the EU Court of Justice, although the Commission decided not to do so, thus implicitly accepting the ruling.

The release as fetched from its publisher. pharmamar.com ↗