Commercial launch activities for Idefirix progressing as planned; Patient recruitment in clinical studies reinitiated in December 2020; Company financed into 2023
Lund February 4, 2021. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, today announced its business update and year-end report for January - December, 2020.
Highlights for the fourth quarter 2020
Commercial launch activities in early launch countries within the European Union are underway as planned. During Q4'20, initial pharmacy level pricing for Idefirix was published in the first markets. National level reimbursement application processes have been initiated, and decisions by authorities in the first of the early launch countries are expected from mid-year onwards. Depending on the impact of the COVID-19 pandemic, access to special and local budgets for individual patients could be achieved by certain centers prior to the granting of national level reimbursement.
US trial: Discussions with the FDA about the study protocol are ongoing. Assuming agreement is reached in the coming months, Hansa will proceed to set up centers in the US. Depending on the impact of the COVID-19 pandemic in the US, enrollment is expected to complete in 2022, as previously guided, with a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.
Patient recruitment in the phase 2 studies in AMR and GBS was reinitiated in December 2020, as previously guided. The recruitment process in both studies had been temporarily paused due to the COVID-19 pandemic. In the AMR trial, 5 patients out of a target of 30 patients have been enrolled, and in the GBS trial 5 patients out of a similar target of 30 patients have been enrolled.
Following the publication of positive high-level data in the anti-GBM phase 2 trial at the end of September 2020, discussions with EMA/FDA will now be initiated to determine the regulatory path forward for this indication.
On October 29, 2020 Hansa Biopharma hosted its third Capital Markets Day. The three hour virtual CMD event was attended by more than 500 live viewers. A recorded version is available on the Company's web.
Investments in SG&A and R&D increased in the fourth quarter to SEK 63.2m (Q4'19: SEK 53.4m) and SEK 50.4m (Q4'19: SEK 57.7m), respectively. Cash position was SEK 1,378m at the end of December 2020. Cash flow from operating activities for the fourth quarter ended at SEK -96.5m (Q4'19: SEK -75.0m).
COVID-19 Pandemic: The global COVID-19 pandemic may still adversely impact Hansa Biopharma's operational business and trial activities.
