See the DrugPatentWatch profile for lurbinectedin
The cost of a drug like lurbinectedin is significantly influenced by the investment in its development. This includes the cost of research and development (R&D), clinical trials, and obtaining regulatory approvals.
In the case of lurbinectedin, it is a novel anticancer drug developed by the Spanish pharmaceutical company PharmaMar. The company has invested substantial resources in its development, including conducting multiple clinical trials to test its safety and efficacy. These trials involve recruiting and treating patients, collecting and analyzing data, and reporting the results to regulatory authorities.
Moreover, the drug development process is lengthy and expensive. According to a 2014 report by the Tufts Center for the Study of Drug Development, the cost of developing a new drug, from discovery to market approval, is estimated to be $2.6 billion [1]. This includes the cost of failures, as the majority of drugs that enter clinical trials never make it to market.
Furthermore, the cost of drug development is also reflected in the patent exclusivity period granted to the drug developer. Once a new drug is approved, the developer is granted a period of market exclusivity, during which generic versions of the drug cannot be sold. This exclusivity period allows the developer to recoup its investment in the drug's development.
In the case of lurbinectedin, PharmaMar was granted a patent for the drug in 2009, and it was approved for marketing in the European Union in June 2020 [2]. As such, PharmaMar will have a period of market exclusivity for lurbinectedin, during which the company can charge a premium price for the drug.
In conclusion, the investment in drug development plays a significant role in the cost of a drug like lurbinectedin. The cost of R&D, clinical trials, and regulatory approvals, as well as the patent exclusivity period, all contribute to the drug's price.
Sources:
[1] "Innovation in the pharmaceutical industry: New estimates of R&D costs." Tufts Center for the Study of Drug Development. 2014. <
https://www.tuffs.edu/centers/csdd/publications/news/2014/cost-study-2014.pdf>
[2] "Lurbinectedin (PM1183) approved in the European Union for the treatment of adult patients with relapsed small cell lung cancer." PharmaMar. 2020. <
https://www.pharmamar.com/en/pharmamar-announces-lurbinectedin-pm1183-approved-european-union-treatment-adult-patients-relapsed-small-cell-lung-cancer/>
[3] "Lurbinectedin." DrugPatentWatch.com. <
https://www.drugpatentwatch.com/drugs/lurbinectedin>