Pharmamar is not only a pioneer for having become the only pharmaceutical company in Spain authorized to supply three anticancer drugs, but also for being the first company worldwide to take on the EU regulatory authority, the European Agency, in court. Agency (EMA), well known for its role during the pandemic.
"We are very shocked," says the president of the company, José María Fernández Sousa-Faro, in a conversation with La Vanguardia, to describe the situation. The litigation affects one of its three star drugs, Aplidin, developed against a type of cancer known as multiple myeloma, and it will foreseeably be resolved in the coming weeks by the Court of Justice of the European Union. It does not look good for Pharmamar because the general lawyer of the EU has issued an opinion that is unfavorable and in the vast majority of cases the judges tend to follow his criteria.
According to the company's version, the EMA refused in 2018 to approve Aplidin for myeloma despite the report in favor of the two experts in charge of evaluating the drug. Pharmamar appealed to the Supreme Court of Justice of Luxembourg (TSJL) alleging a conflict of interest of various members of the EMA linked to the Dutch Karolinska institute, which has a spin-off also dedicated to developing a similar drug. The court agreed with him, but two countries, Estonia and Germany, appealed the decision "in a surprising way," says Fernández Sousa-Faro.
The case has been raised to the CJEU and, after the opinion of the general lawyer of the EU, it has set off all the alarms in Pharmamar. "His argument about him is a fallacy," says the president of the company. "He says that there was no conflict of interest based on the fact that the Karolinska Institute is not a company" and that "there are already many treatments for myeloma, when this is not the case because in each cancer there are several lines of treatment." If the ruling is favourable, the EMA would have to re-evaluate the drug based on the information available, in a process that could take about a year.
Is it a problem facing the referee? “It should not affect other running processes. We are opening the way for other competitors in the industry”, affirms the president of the company.
The litigation around Aplidin, which has been approved in Australia, has its derivative because the drug is also the antiviral that at the time catapulted Pharmamar's price up to taking it to the Ibex. If the EMA had accepted it for myeloma, it would have been able to start the trials for covid in phase three, which is the most advanced, but this has not been the case, and the process has slowed down until it ran aground. This week Pharmamar decided to give up promoting it as a drug against covid: "We have closed the study due to a lack of patients and because there are already other drugs," says its president.
Aplidin is one of Pharmamar's three star drugs. The other two are Yondelis, against sarcoma, and Zepzelca, against lung cancer. 90% of all drugs subject to clinical trials do not achieve marketing authorization, and only 1% of biotech companies have managed to place three products on the market.
Based in the Madrid town of Colmenar Viejo, Pharmamar actually has an origin linked to the sea. It develops its molecules from marine components, and its president and main shareholder, with 11%, is the son of the founder of Pescanova, José Fernández. The family line took two paths, that of Pharmamar and that of Pescanova, directed by his brother Manuel until the fishing giant fell into disgrace. The Supreme Court has just reduced Manuel's sentence to six years in prison for manipulating Pescanova's accounts in order to obtain financing. “Neither am I a Pescanova shareholder nor is my brother a Pharmamar shareholder. The only connection is the family”, affirms the president of the pharmaceutical group.
