The Director of Equity Research at Barclays in the U.S, Balaji Prasad, also specialized in biotechnology and pharmaceuticals, pointed out in a recent report on Jazz Pharmaceuticals that the underlying growth of the Zepzelca from Phammar is “intact”.
Prasad points to growth over 10 percent and estimates that projected studies with the drug against small cell lung cancer “Will help ensure long-term growth”.
Although Pharmamar has up to seven open investigations with its antitumor, Prasad focuses on the three most relevant for the short term and first mentions the entry on the scene of Roche with his Tecentriq.
Zepzelca jump to the front line
This drug is referenced as an inhibitor of the disease and therefore its effectiveness will be tested with Zepzelca as a complementary therapy with the aim of increasing life expectancy which currently does not exceed 2 years for patients with this pathology.
The trial will be phase III and patients are already being recruited with the aim of starting the trial at the end of the year. The study will be in the first line, that is, it will be the first treatment option, something new since to date Zepzelca had only been tested in the second line after a first platinum-based chemotherapy treatment.
The Barclays expert also mentions the confirmatory trial of Zepzelca, he estimates that it will begin at the end of the year, which will be the key to achieving the authorization for the total sale of the product in the United States.
Pharmamar caresses 150 million in short-term income
To date, the drug is sold in the country under the emergency sale formula as it is a drug for an unmet medical need. LThe authorization will mean the entry of 150 million dollars for Pharmamar per the license agreement granted to Jazz.
After this entry, at stake will be 550 million dollars more than the biopharmaceutical would receive based on royalties by sales, penetration in other markets and possible new applications.
The third study indicated by Prasad is a phase two that should begin during the first quarter of 2022. The objective will be to test the efficacy of Zepzelca against advanced and metastatic tumors.
Record quarter in the US
In this sense, Pharmamar has found “A highly promising activity” of Zepzelca against white tissue sarcoma and more specifically with the synovial subtype, as reported to the company at different oncology conferences this year.
At the moment, Zezpelca closed a record third quarter in the United States. Jazz Pharmaceuticals brought in $ 7.1 million from July to September from sales of this product, the best quarter since the drug was on sale.
The figure is 94 percent higher than the same period of the previous year when the sale of the product began at the end of July. In total, the Pharmamar partner has accumulated sales of 182 million dollars since it is on the market.
The Zepzelca in Europe, by 2023
The goal of Pharmamar and Jazz Pharmaceuticals is to have the final approval of the US FDA in 2022. Pharmamar’s first forecasts pointed to the first quarter of next year, but the evolution of the confirmatory trial invites us to think about the second half.
Regarding the sale in the European Union, where Pharmamar will seek authorization from the EMA alone, the process is at least one year behind the United States so it would be from the second half of 2023 when the product could reach the market.
The biopharmaceutical of Galician origin will use the confirmatory trial in the United States to speed up approval in the European Union, which could speed up the procedures, mainly those for the compilation of documentation.