We are pleased to announce that, following the successful completion of our ANDA for Midostaurin Capsules 25mg in the US, we have now completed our Pivotal BE program in Europe. We will proceed with dossier filing, upon exclusivity expiry in Europe.
Our product has been developed based on the reference brand Rydapt 25mg soft gel capsules, which is indicated in the treatment of acute myeloid leukemia (AML) and aggressive systemic mastocytosis (ASM) and sold at around $281mio globally in 2021, having a significant growth potential with Global 3Y CAGR at 18%, according to IQVIA.
Based on our positive progress, we believe we will be amongst the first Companies to register and market this product on Day-1 in Europe.
This development further enhances our oncology capabilities and due to its challenging nature, showcases our ability to bring differentiated solid oncology products to our partners in a timely manner, ensuring perfect quality and competitive COGS.