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The strategy and objective of Biopharma is to broaden the application of imlifidase as a potential therapy to change the
FREMONT CA: Hansa Biopharma is a pioneer in enzyme technology for uncommon immunological conditions. Hansa continues to achieve significant success in its clinical, commercial, and corporate strategies as it establishes and advances its pipeline of important drug candidates for rare immunologic diseases and launches Idefirix in Europe.
Idefirix is the only drug which has received approval, in the EU, that enables kidney transplants in highly sensitized patients who are incompatible with a deceased donor. Currently, Hansa's market access initiatives in Europe are proceeding as planned among the nations where it has recently been launched. Pricing and reimbursement have now been established in four countries: Sweden, the Netherlands, and on a hospital basis in Finland and Greece. After completing HTA filings in all five of Europe's largest markets and receiving the receipt of initiation of procedures from the Ministry of Health in Spain, The Health Technology Assessment dossier for Spain is believed to be submitted during the first quarter of 2022.
Last year, Medison Pharma and Hansa declared a multiregional commercialization agreement for Hansa's desensitization treatment for kidney transplantation, which will cover Israel and major Central Eastern European nations. Commercialization will be based on Europe's present conditional marketing authorization and Israel's Ministry of Health's pending marketing authentication. Hansa has reached a significant milestone with its commercial relationship with Medison Pharma, as the company develops access to imlifidase highly sensitized patients who are incompatible with a deceased donor.
In conclusion, Hansa wishes to start a Post Approval Study (PAS) in Europe in 2022, with roughly 50 highly hypersensitive patients receiving imlifidase treatment. The new study will expand to around 20 clinics across major academic centres in Europe, beyond the first wave of investigators in the Phase 2 projects. While they continue to grow their commercial capabilities globally, each center will enroll between two to five patients, laying the foundation for a new standard of care in desensitization.