The latest anti-tumor from the Spanish PharmaMar will be a reference treatment worldwide. The pharmaceutical company’s partner in the United States, Jazz Pharmaceutical, has presented the preliminary results of a clinical trial in which this medication is used in combination with one from the multinational Roche (Tecentriq) and the data obtained will allow the therapy, with permission from regulatory agencies, escalate from the second treatment option to the first. After hearing the news, the Spanish firm has catapulted onto the stock market and its shares have risen by around 28%.
To date, the only commercial window for the drug was thanks to an accelerated approval granted by the FDA and exploited by Jazz Pharmaceutical, which at the end of 2019 purchased the drug for exploitation in the US for up to $1 billion. This authorization was limited to second line treatment, but now the data collected in the clinical trial pwill allow its use to be escalated to first option in lung cancerone of the most prevalent and deadly.
On an economic level, in the first instance, the greater use of the drug in the United States will bring greater benefits to the Spanish company. It must be remembered that PharmaMar agreed with Jazz to collect double-digit royalties, which until now were the figure that brought the good news in the income statements, since Yondelis, since generics appeared, has been deteriorating in the market .
But also, At the regulatory level, this preliminary data will serve two purposes.. On the one hand, Jazz will use them so that the FDA grants them final approval of the drug, a circumstance that will result in PharmaMar paying around 50 million euros to achieve a new regulatory milestone in the United States. But in addition, the Spanish pharmaceutical company will use this data to obtain marketing registration in Europe, a fact that will be a milestone for the company that until now they had only achieved with Yondelis. It will be then when Fernández Sousa-Faro’s firm can market the medicine on its own (or through partners) in the Old Continent.
“PharmaMar will submit the marketing authorization application (MAA) to the EMA in the first half of 2025 to apply for approval in the European Union. “Lurbinectedin is already approved in 16 territories around the world,” the company says in a statement to the CNMV.
Jazz, who for this trial has gone hand in hand with Roche (owner of Tecentriq), assures that he will present the final data at a medical congress. Although they have not decided which or when, it could be in May of next year, at the American Congress of Oncology (ASCO).
