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Hansa Biopharma advances to business stage following conditional EU approval of Idefirix; Optimistic high-level knowledge from investigator-initiated part 2 trial with imlifidase in anti-GBM
LUND, Sweden, Oct. 22, 2020 /PRNewswire/ — Hansa Biopharma, the chief in immunomodulatory enzyme expertise for uncommon IgG mediated ailments, at the moment introduced its enterprise replace and interim report for January – September, 2020.
Highlights for the third quarter 2020
- The EU Fee granted conditional approval for Idefirix® (imlifidase) in extremely sensitized kidney transplant sufferers within the European Union. Idefirix is the Firm’s first authorized drug and can rework Hansa Biopharma right into a business stage biopharmaceutical firm.
- Entered unique settlement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment forward of gene remedy in choose indications. The settlement with Sarepta contains an upfront cost and can doubtlessly generate milestone funds to Hansa totaling as much as USD 397.5m plus royalties on imlifidase enabled gene remedy gross sales. All imlifidase gross sales will likely be booked by Hansa.
- Anti-GBM: Reported constructive high-level knowledge from investigator-initiated part 2 trial with imlifidase to deal with anti-GBM illness with two-thirds of sufferers attaining dialysis independence six months after therapy. The constructive knowledge marks an necessary milestone for the Firm’s enlargement of imlifidase outdoors transplantation.
- US trial in kidney transplantation: Recruitment of first affected person anticipated in H1 2021, given the continued influence of the COVID-19 pandemic within the US and the timeline to finalize the research protocol. Potential BLA submission is anticipated by 2023 underneath the accelerated approval path.
- Pipeline: Enrollment in each part 2 research in GBS and AMR have been briefly halted for the previous months as a result of COVID-19 pandemic. Reinitiation of enrollment anticipated in This fall 2020 underneath a risk-based site-by-site method. Completion of enrollment in each research is anticipated within the second half of 2021.
- Hansa Biopharma AB licensed as a Nice Place to Work® following the outcomes of a company-wide worker survey and a assessment of insurance policies.
- SEK 1.1bn (USD 121m) raised in a directed share situation of 4.Four million strange shares. The share situation was a number of occasions oversubscribed because of excessive demand from US, European and Swedish institutional traders. The capital raised will assist finance the Firm’s R&D pipeline in addition to fund the launch and commercialization of imlifidase in kidney transplantation.
- Max Sakajja, VP Company Improvement, appointed to a brand new function as VP Worldwide Markets to arrange Hansa Biopharma’s enlargement technique outdoors the EU. The function studies into the CCO and is a part of Hansa’s broader management group.
- Investments in R&D and SG&A elevated within the third quarter to SEK 71m (Q3’19: SEK 47m) and SEK 52m (Q3’19: SEK 46m), respectively. Money place was SEK 1,476m on the finish of September 2020. Money circulation from working actions for the third quarter ended at SEK 5m (Q3’19: SEK -80m).
Søren Tulstrup, President and CEO of Hansa Biopharma, feedback
“Hansa Biopharma’s evolution into a totally built-in biopharmaceutical firm took a significant step ahead within the third quarter following the conditional approval of Idefirix (imlifidase) by the European Fee for the desensitization therapy of extremely sensitized grownup kidney transplant sufferers with a constructive crossmatch towards an obtainable deceased donor.
The European approval serves as a validation of the potential of our proprietary drug improvement platform and can transistion Hansa Biopharma into the subsequent part as a business stage biopharmaceutical firm.
We’re additionally excited in regards to the progress of our efforts past transplantation. In July we introduced the achievement of one other landmark milestone with the unique settlement with Sarepta Therapeutics to develop and promote imlifidase as a possible pre-treatment previous to the administration of gene remedy. The settlement with Sarepta is unique for the use in Duchenne and and Limb-Girdle indications and serves as a validation of our enzyme expertise as we develop past transplantation.
Late Septermber we additionally introduced constructive high-level knowledge from the investigator-initiated part 2 trial with imlifidase to deal with anti-GBM illness. Information from the trial exhibits that imlifidase results in fast clearance of anti-GBM antibodies, with two-thirds of sufferers attaining dialysis independence six months after therapy. We’re very inspired by the constructive final result as anti-GBM is the primary IgG-mediated illness outdoors transplantation, the place imlifidase has been proven to cease an immunologic assault.
Our robust progress throughout our platform of immunomodulatory enzymes has additionally been acknowledged by our traders, as our investor base has continued to develop in Sweden and internationally. Finish of September, the variety of shareholders has elevated to greater than 18,000 traders, with 45% of the shares now owned by worldwide traders and establishments. We see this as a sworn statement to our current progress and a robust and rising worldwide curiosity in Hansa Biopharma.
Whereas an thrilling and transformative yr has impacted us in a postive approach, we’re nonetheless seeing adverse results as a result of widespread influence from the COVID-19 pandemic. Enrollment within the part 2 research in GBS and AMR has been briefly halted for the previous months, and we count on to reinitiate enrollment of those research within the fourth quarter 2020 underneath a risk-based, site-by-site method.
Within the US, the proposed research protocol for a randomised managed trial (RCT) concentrating on highly-sensitized kidney sufferers was submitted to the FDA in June, 2020. Discussions are at the moment ongoing with the FDA and, as soon as the ultimate protocol has been agreed upon, we are going to proceed to arrange facilities within the US and begin to enroll sufferers. Given the continued influence of the COVID-19 pandemic and the timeline for finalization of the research protocol, we count on recruitment of the primary affected person to be within the first half of 2021 with a possible BLA submission in 2023.
Lastly, I additionally need to spotlight that Hansa Biopharma AB not too long ago obtained licensed as a Nice Place to Work®. This certification displays our efforts to construct a robust group by way of attracting, growing and retaining the perfect expertise within the trade as we proceed our development trajectory and improvement into a totally built-in biopharmaceutical firm.
I sit up for conserving you up to date on the progress of our journey.”
Upcoming milestones and information circulation
This fall 2020 Kidney transplantation EU: Business launch
H1 2021 Kidney transplantation US: First affected person dosed / RCT
H1 2021 NiceR: Completion of GMP course of; provoke IND-enabling tox research
H2 2021 AMR Section 2 research: Full enrollment
H2 2021 GBS Section 2 research: Full enrollment
2022 Kidney transplantation US: Full enrollment / RCT
H2 2022 AMR Section 2 research: Information learn out
H2 2022 GBS Section 2 research: Information learn out
2023 Kidney transplantation US: 12 months follow-up on eGFR accomplished / RCT
2023 Kidney transplantation US: BLA submission
Capital Markets Day
Hansa Biopharma to host Capital Markets Day on Thursday October 29, 2020 in Copenhagen
The CMD occasion will likely be centered round Hansa Biopharma’s transformation into a totally built-in and business stage biopharmaceutical firm and can spotlight the potential of the Firm’s distinctive antibody-cleaving enzyme platform past transplantation in areas resembling autoimmunity and gene remedy.
The occasion will function each senior administration and exterior visitor audio system. The occasion will likely be livestreamed and obtainable for all viewers on our net at http://www.hansabiopharma.com.
In case you want to take part within the CMD nearly, kindly enroll utilizing the next hyperlink https://hansa.eventcdn.net/2020cmd/
No convention name scheduled on Oct 22, 2020
Since Hansa Biopharma will host its Capital Markets Day per week later than the Q3’2020 report it has been determined to incoporate related parts and updates from the third quarter into the CMD program and displays reasonably than internet hosting a seperate Q3 convention name. There will likely be opportunites to ask questions throughout the Capital Markets Day.
The interim report and newest investor presentation might be downloaded from our net
Interim report January – September 2020
Investor street present presentation Q3, 2020
For additional data, please contact:
Klaus Sindahl, Head of Investor Relations
Cell: +46 (0) 709-298 269
Head of Company Communications
Cell: +46 (0) 768-198 326
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SOURCE Hansa Biopharma AB
Firm Codes: Bloomberg:HNSA@SS, ISIN:SE0002148817, RICS:HNSA.ST, Stockholm:HNSA
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