On February 3, 2021 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and year-end report for January – December, 2020 (Press release, Hansa Biopharma, FEB 3, 2021, View Source [SID1234574591]).
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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.
Søren Tulstrup, President and CEO of Hansa Biopharma, comments
"Hansa Biopharma enters the new year well positioned to execute successfully on our key priorities and objectives for 2021, which are to ensure the successful launch of Idefirix (imlifidase) in leading transplantation centers in select European markets, initiate a randomized, controlled clinical study in the US to support a future filing of a BLA for imlifidase in highly sensitized patients waiting for a kidney transplant, and continue the strong current momentum behind our efforts to advance our pipeline of drug candidates within autoimmune diseases and gene therapy.
2020 was overall a very successful and transformative year for Hansa Biopharma – a year which saw significant milestones achieved, including the conditional approval of Idefirix by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
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 Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy for Duchenne muscular dystrophy and Limb-girdle muscular dystrophy in patients with neutralizing antibodies (NAbs) to adeno-associated virus (AAV). The partnership is progressing as planned, and during the second half of 2020 Sarepta initiated ongoing pre-clinical investigations with imlifidase in the gene therapy setting.
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 Hansa Biopharma with a lot of progress, we have also seen the negative effects from the escalating COVID-19 pandemic impacting our operational business and trial activities during the year. The global COVID-19 pandemic may still adversely impact Hansa Biopharma’s operational business and trial activities in 2021, and the Company will continue to take appropriate measures to protect employees and take social responsibility during this global healthcare crisis while working to limit the potential negative effects on our business.
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 December 2020, patient enrollment was reinitiated in both studies under a risk-based, site-by-site approach. Depending on the development of the COVID-19 pandemic and its impact, we expect to finalize recruitment in both studies towards the end of this year.
In the US, we are currently in ongoing discussions with the U.S. Food and Drug Administration (FDA) about a proposed study protocol for a new, randomized controlled study of imlifidase for the desensitization treatment of highly sensitized adult kidney transplant patients. Assuming a near term approval of the final study protocol, and depending on the development of the COVID-19 pandemic in the United States and its impact on patient enrollment, the Company expects to complete enrollment of this study in 2022, enabling a potential Biologics License Application (BLA) submission by 2023 under the accelerated approval pathway.
Hansa Biopharma’s evolution into a fully integrated, commercial stage biopharmaceutical company is becoming a reality now. An exciting year lies ahead of us with the commercial roll-out of the Company’s first approved drug, Idefirix, developed to help highly sensitized patients get off dialysis by enabling a lifesaving transplantation.
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
Hansa Biopharma will host a telephone conference today Thursday February 4 14:00 CET / 8:00am EST
The presentation will be held in English and be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota. Slides used in the presentation will be live on the company website during the call under "Events & Presentations" and will also be made available online after the call.