BioMarin Restricts Roctavian Sales to U.S., Germany, and Italy Amid Stagnant Sales

Market Focus::
BioMarin will focus its Roctavian efforts on the U.S., Germany, and Italy, where the gene therapy is approved and reimbursed.

Cost Reduction::
The company aims to lower annual direct expenses related to Roctavian to approximately $60 million starting in 2025, with the goal of achieving profitability by the end of that year.

Sales Performance::
Despite FDA approval in June 2023, Roctavian has struggled with sales, generating only $7 million in revenue from treating five patients between April and June 2024.

Clinical Development::
BioMarin will not enroll new participants in clinical development programs for Roctavian but will continue to monitor existing patients for long-term safety and efficacy.

Production Status::
The gene therapy production facility has been temporarily put in an idle state until additional production is needed.

Pricing::
The list price for Roctavian in the U.S. is $2.9 million, while in Germany, the agreed price equates to about $900,000 per patient.

Competitive Landscape::
The arrival of newer drugs like Roche’s Hemlibra and Sanofi’s Altuviiio has given patients alternative options, potentially impacting Roctavian’s appeal.