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The General Court of the EU agrees with PharmaMar in the decision on Aplidin

2020-10-28T15:05:47.708Z


The shares of the Galician company soar 10% on the stock marketPharmamar soars 7% on the stock market after learning that the General Court of the European Union has fully estimated the company's claim, annulling the European Commission Decision denying the marketing of Aplidin (plitidepsin) for the treatment of patients with multiple myeloma, as well as ordering the Commission to pay the costs. As the company reports in a statement sent to the CNMV, on Octo


Pharmamar soars 7% on the stock market after learning that the General Court of the European Union has fully estimated the company's claim, annulling the European Commission Decision denying the marketing of

Aplidin

(plitidepsin) for the treatment of patients with multiple myeloma, as well as ordering the Commission to pay the costs.

As the company reports in a statement sent to the CNMV, on October 1, 2018, PharmaMar filed a lawsuit before the General Court of the European Union against the European Commission requesting the annulment of the Commission's Execution Decision, whereby the marketing authorization for plitidepsin as a treatment for patients with multiple myeloma was denied.

At the time, Aplidin was intended to be the second drug, an antitumor, that the company put on the market after Yondelis.

But the

European Medicines Agency (EMA) rejected its use.

This same drug is that PharmaMar has now reconverted as an experimental use, in lower doses, as a treatment against Covid-19.

The company plans to advance trials with patients in the US and Europe, news that has been well received on the stock market.

However, the company to questions from this newspaper does not reveal what decision it will make about Aplidin as an antitumor, if it will ask for its marketing for Europe again, and it extends the company's decision to future dates.

In this lawsuit, the company asked the Court to clarify the procedural guarantees and the examination criteria that must be applied during a procedure for marketing authorization before the EMA.

PHARMA MAR SA112,302.18%

Specifically, the main reasons for the lawsuit related to the strict verification of conflicts of interest by the experts appointed by the EMA and the correct analysis of the scientific evidence presented by PharmaMar.

Today's decision by the General Court of the European Union "corroborates the position that PharmaMar has maintained at all times on the evaluation process of plitidepsin as a treatment for patients with multiple myeloma", according to the company's version.

Source: elparis

All news articles on 2020-10-28

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