Commercial launch activities for Idefirix® progressing as planned; Patient recruitment in clinical studies reinitiated in
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 ) andSEK 50.4m (Q4'19:SEK 57.7m ), respectively. Cash position wasSEK 1,378m at the end ofDecember 2020 . Cash flow from operating activities for the fourth quarter ended atSEK -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.
Søren Tulstrup, President and CEO of
"
2020 was overall a very successful and transformative year for
We are also very excited about the progress of our efforts to advance a valuable pipeline of drug candidates in therapeutic areas beyond transplantation. In July, we announced the achievement of a landmark milestone with the agreement with
We also announced positive high-level data from an investigator-initiated phase 2 trial with imlifidase in anti-GBM antibody disease, evaluating safety, tolerability and efficacy of imlifidase in 15 severe anti-GBM patients. We are very encouraged by the positive outcome, demonstrating that two-thirds of the anti-GBM patients achieved dialysis independence six months after treatment. The positive data marks another important milestone for the advancement of a valuable pipeline of drug candidates targeting indications beyond transplantation.
While 2020 has been a transformative year for
In relation to COVID-19, we have seen our pipeline activities materially impacted during 2020 by the pandemic. Recruitment of patients in the GBS and AMR studies was temporarily halted during a large part of the year. In
In the US, we are currently in ongoing discussions with the
I look forward to updating you on progress in our efforts to deliver on our mission to bring lifesaving and life altering therapies to the patients with rare diseases who need them and generate value to society at large."
Upcoming milestones and news flow
Q1 2021 Kidney transplantation EU: Commercial launch
H1 2021 3-year data read-out long term follow-up study in kidney transplant patients
H1 2021 NiceR: initiate IND-enabling tox studies
H1 2021 Kidney transplantation US: First patient dosed / RCT
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
2022 Kidney transplantation US: Complete enrollment / RCT
2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT
2023 Kidney transplantation US: BLA submission
Conference call details
The presentation will be held in English and be hosted by
To participate in the telephone conference, please use the dial-in details provided below:
The webcast will be available on following link
The interim report and latest investor presentation can be downloaded from our web
Year-end report January -
Investor road show presentation Q4, 2020 link
This is information that
For further information, please contact:
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
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