Wednesday, December 8

Pharmamar’s Zepzelca closes a record quarter in the US

The antitumor Zepzelca from Pharmamar achieved the highest sales in the third quarter since it began to be marketed in the United States more than a year ago. Jazz Pharmaceuticals it entered 71.7 million for the product from July to September.

Sales are 94 percent more than in the same period of the previous year when the sale of the drug began at the end of July 2020. The partner of the Spanish company accumulates sales for this drug against small cell lung cancer that reach 182 million dollars since it reached the market.

From Jazz Pharmacueticals iThey insist that Zepzelca will continue to gain market share in the short term and as a sign of their confidence in the drug created with Pharmamar, they have already started the study planned with Roche for the end of the year.

550 million sales royalties

The biopharmaceutical indicated at the end of the first half that it would carry out a phase three trial to measure the efficacy of Zepzelca combined with Tecentriq from Roche, while preparing a confirmatory trial with Pharmamar to achieve final sales approval in the United States.

The great beneficiary of Jazz records is Pharmamar itself, since at stake are 550 million euros in royalties for drug sales milestones, The benefits of the group of Galician origin were deflated due to the lack of income in this way.

In addition, another 150 million euros would arrive for the company led by Jose Maria Fernandez Sousa when the authorization of total sale by the US FDA is achieved and it is in this aspect where the doubts of the experts appear.

Dance of dates for the total sale in the USA

Fernández Sousa, in an interview with, pointed out that they expected to have the go-ahead during the first quarter of 2022, but different investment entities that closely follow the ‘biotech’, such as Oddo BHF, Intermoney O Bankinter they point, in the best of cases, to the end of that year.

Although other relevant brokers in Pharmamar such as RX Securities they do consider that it could comply with the estimates advanced by At the moment, the biopharmaceutical has already entered 300 million dollars of the 1,000 million possible for the license agreement.

The confirmatory trial with Jazz Pharmaceuticals, which is based on first-line efficacy in conjunction with classic platinum-based chemotherapy treatment, will also serve Pharmamar in seeking approval in the European Union.

Marketing in the EU, from 2023

The company thus activates the process for the EMA to authorize the sale of the product in the Member States, but the work is more than a year behind the United States, so it will be from 2023 when the delivery of documentation to the community health authority can be produced.

Despite this, and beyond the confirmatory trial and the alliance with Roche, Pharmamar has another five trials open with Zepzelca to achieve new applications beyond the drug’s efficacy as a second-line treatment in small cell lung cancer.

The most developed ones pass their effectiveness against soft tissue sarcoma and more specifically with the synovial subtype.

Meanwhile, Pharmamar squeezes Zepzelca solo in the European Union via compassionate use route and closed the first nine months of the year with sales under this formula of 23.3 million euros, which shows that the income in this parcel stabilizes at 7 million euros per quarter.

So far this year, the shares of Pharmamar they fell just over 13 percent on the Madrid Stock Exchange.