Pharmamar the goal of selling is set Zepzelca alone in the Old Continent. The biopharmaceutical leaves the Irish company out of the process Jazz Pharmacueticals with which he markets the product in the United States, as he learned finanzas.com by company sources.
If they had had their partner on the other side of the Atlantic, both companies would have to have reached a new license extension agreement for the Old Continent.
The one signed for the United States reaches 1,000 million dollars and for Europe “It should have been vastly higher because the number of potential patients is growing exponentially in Europe”, state the sources consulted.
Collaboration with Jazz Pharmaceuticals will continue
Pharmamar’s strategy has not meant “a change in good relations with Jazz”, they point out from the Spanish biotech, and an example of this is “the new test that we are going to carry out, which will be essential to request marketing authorization from the EMA”, they add.
The biopharmaceutical took advantage of the presentation of results until September to communicate that it plans to start a confirmatory trial of Zepzelca in second-line recurrent small cell lung cancer by the end of the year.
The trial will consist of three arms, comparing Zepzelca as monotherapy or in combination with irinotecan, versus the investigators’ choice of irinotecan or topotecan.
Second attempt after the Atlantis fiasco
In case of being positive, from Pharmamar they discount that this will be the case, will be used with both the United States FDA, seeking full marketing approval (currently approved under emergency), cas registering it in Europe through the community agency, the EMA.
This is the second attempt by Pharmamar to commercialize its antitumor called lurbinectidine in the Old Continent after the trial fiasco Atlantis.
The study was positive, but the comparisons and combinations in which Zepzelca was applied they were not sufficiently superior to the drugs already marketed so the marketing request was discarded.
Sales target in 2023
Lsight for sale in Europe is set in 2023, as pointed out by the president of the group of Galician origin, Jose Maria Fernandez Sousa, in an interview with finanzas.com.
Fernández Sousa pointed out that the processes are one year behind the United States where they expect the go-ahead to marketing in the first quarter of next year.
At the moment, Pharmamar already sells Zepzelca in Europe thanks to provisional marketing in the United States under the compassionate use formula.
Sales figures in the Old Continent under this method are over 7.5 million euros per quarter.
Zepzelca closed the first nine months of this year with sales in Europe of 23.3 million euros, while it entered royalties on sales based on its license agreement for Jazz Pharmaceuticals of 24.4 million euros in the same period.
Revenues are at the same level in Europe and the US
The figures show that, as finance.com showed at the end of the first half, that Pharmamar is being able to sell both Zepzelca in Europe as royalties it receives from its partner in the United States.
A position from which Pharmamar highlights its ability to sell Zepzelca alone in Europe, as they are doing so to date “With a good evolution of income and a great acceptance by the medical community when seeing the results of the studies and the improvement of their patients”, emphasize from the company.
While the work towards commercialization is carried out in Europe, Pharmamar will continue in its work to reach the 1 billion dollars of the agreement with Jazz for which it needs the final approval of the drug by the FDA and to meet the sales milestones. .