Anticancer drug PharmaMar will become the first treatment option for lung cancer and will rise in price on the stock market by almost 15%.
The newest antitumor drug from the Spanish company PharmaMar will become a reference drug throughout the world.. The pharmaceutical company’s US partner, Jazz Pharmaceutical, presented preliminary results from a clinical trial in which the drug is used in combination with multinational Roche’s drug (Tecentriq), and the findings will allow the therapy to move from the second treatment option to the first with regulatory approval. Upon hearing the news, the Spanish firm went public on the stock market and its shares rose almost 15%.
To date, the only commercial window for the drug has come through an accelerated approval granted by the FDA and used by Jazz Pharmaceutical, which acquired the drug for use in the US in late 2019 for up to $1 billion. This approval was limited to second-line treatment, but now data collected in a clinical trialwill expand its use to be the first treatment option for lung cancerone of the most common and deadly.
On an economic level, first and foremost, wider use of the drug in the United States will greatly benefit the Spanish company. It’s worth remembering that PharmaMar agreed with Jazz to charge double-digit royalties, which has so far been a figure that has brought good news on earnings reports as Yondelis has been deteriorating in the market since the introduction of generics.
But also, At the regulatory level, these preliminary data will serve two purposes.. On the one hand, Jazz will use them to get the FDA to grant them final approval of the drug. This development will result in PharmaMar paying approximately €50 million 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, and this fact will be an important milestone for the company, which until now they have only achieved with Yondelis. It is then that Fernandez Sousa-Faro’s company will be able to sell the medicine independently (or through partners) on the Old Continent.
“PharmaMar will submit a marketing authorization application (MAA) to the EMA in the first half of 2025. apply for approval in the European Union. “Lurbinectin has already been approved in 16 territories worldwide,” the company said in a statement to the CNMV.
Jazz, who worked hand in hand with Roche (the owner of Tecentriq) in this study, says it will present the final data at a medical congress. Although they haven’t yet decided if or when, it could happen next May at the American Congress on Oncology (ASCO).
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