Pharmamar Y Jazz Pharmaceuticals have announced the start of a phase three trial, the pre-commercialization of a drug, with Secure against recurrent small cell lung cancer.
The trial will be confirmatory in order to obtain the authorization for the total sale of the product in the United States, after in June of this year the US sanitary regulator, the FDA, the provisional sale authorization was granted to the drug.
Pharmamar will use this study, called Lagoon, as a registration test for the European Medicines Agency, the EMA for its acronym in English.
EMA authorization, by 2023
The Spanish biopharmaceutical is thus taking the first step to obtain the authorization of its flagship drug in the Old Continent, where it will market the product without Jazz Pharmaceuticals.
The group of Galician origin already sells Zepzelca in Europe through compassionate use with a relevant penetration of the product in countries such as France, which invites Pharmamar to be optimistic with the expansion of the drug in the European Union.
Pharmamar’s first estimates suggested that Zepzelca would achieve FDA clearance in early 2022, but starting Lagoon at the end of 2021 is expected to achieve full commercialization at best by the end of the year that comes.
This implies a delay of at least one year in the European Union, so It would not be until the end of 2023 when the drug would fully enter the European market.
Zepzelca’s record quarter
The confidence of Pharmamar and Jazz Pharmaceuticals is maximum in the product after closing the third quarter with the best sales record for Zepzelca since it began to be marketed in July this year.
Lagoon is a global, open and multicenter study where Zepzelca will be tested in 705 volunteers from 100 centers distributed mainly between North America and Europe, as reported by Pharmamar.
The drug will be tested as monotherapy or in combination with irinotecan. in second line in those patients who have already been treated with platinum-based chemotherapy if this treatment has not slowed the progression of the cancer.
All in all, Zepzelca has achieved marketing authorization this year in United Arab Emirates, Canada, Australia Y Singapore after signing Pharmamar license extensions with different partners in each country.
Pharmamar “Expect other marketing authorizations in 2022 and beyond”, as reported by the ‘biotech’ in the relevant information sent to the National Securities Market Commission in which it has communicated the start of Lagoon.