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04-Mar-2024

CSL Behring Signs First Commercial Agreement in Austria to Fund Haemophilia B Gene Therapy HEMGENIX®

MARBURG, GERMANY – March 4, 2024 – Global biotechnology leader CSL Behring (ASX: CSL) today announced that a commercial contract has been signed to fund HEMGENIX® (etranacogene dezaparvovec) in Austria, with the option to access a dedicated fund, established by the provinces for specialised medicines. This is the first commercial agreement in Austria for HEMGENIX® and will enable access to the gene therapy for haemophilia B patients.

HEMGENIX® is the first and only one-time gene therapy approved in Austria for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors.[i]

This pioneering funding solution plays an important role in the broader paradigm shift being seen in the treatment of haemophilia B. Expanded access to HEMGENIX® will continue to progress the move away from lifelong intravenous factor IX infusions, which can significantly impact the quality of life and wellbeing of patients.[ii]

“Over the past two years we have worked diligently with all relevant stakeholders to enable access to HEMGENIX®,” said Dr Beate Pettinger-Natmeßnig, General Manager Commercial Operations Austria, CSL Behring. “The agreement signed for HEMGENIX® demonstrates the Austrian healthcare system's commitment to provide access to gene therapy and to break new ground in the financing of advanced therapy medicinal products."

With this agreement in place, eligible patients in Austria with severe and moderately severe haemophilia B can be treated with HEMGENIX® at the Haemophilia Comprehensive Care Centre at the Medical University of Vienna, the first HUB-centre in the country.

“It is hugely encouraging to see pioneering funding solutions being developed and realised across Europe,” said Dr Lutz Bonacker, SVP and General Manager Commercial Operations Europe, CSL Behring. “The new commercial agreement in Austria is a strong signal to how innovative and collaborative thinking can bring a transformative impact for patients and their loved ones, for whom there is still significant unmet need in haemophilia B.”

[i] European Medicines Agency. First Gene therapy to treat haemophilia B. Available at: https://www.ema.europa.eu/en/news/first-gene-therapy-treat-haemophilia-b. [Accessed March 2024].

[ii] Srivastava A et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia 2020; 26(Suppl 6):1-158.

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Last Updated: 04-Mar-2024