Ad hoc-Mitteilungen

Basilea reports progress on the implementation of its strategy to focus on anti-infectives

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  • ERADICATE phase 3 study exploring ceftobiprole for the treatment of patients with Staphylococcus aureus bacteremia (SAB) expected to report results shortly
  • Separate transactions for TTK/PLK1 inhibitor (BAL0891) and preclinical oncology projects expected to be concluded in H2 2022
  • No expansion of ongoing lisavanbulin clinical studies; exploring partnering opportunities
  • Derazantinib rights to be transferred back to Merck & Co. by the end of 2022
  • No material expenses related to oncology activities beyond 2022 and sustainable profitability expected in 2023
  • Strategy implementation on track
Ad hoc announcement pursuant to Art. 53 LR

Basel/Allschwil, Switzerland, June 27, 2022

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company, announced today an update on the progress made in the implementation of its strategic focus on anti-infectives.

David Veitch, Chief Executive Officer, stated: “We have made significant progress in the implementation of our new strategy. With regard to our oncology business, we have run a broad partnering process, whilst continuing to generate clinical data from the ongoing clinical trials. This allows us now to make informed decisions on each asset in order to ensure that we can focus our resources on our anti-infectives business as of 2023. The ERADICATE phase 3 study exploring ceftobiprole for the treatment of patients with Staphylococcus aureus bacteremia, or SAB, is on track to report results shortly and the preclinical profiling of the recently in-licensed potential first-in-class antifungal has also been initiated.”

Partnering discussions for the TTK/PLK1-inhibitor (BAL0891) and preclinical oncology assets are well advanced and expected to be concluded in H2 2022. In line with its strategic priorities and based on data from the ongoing open-label studies, Basilea has decided not to expand the studies for the tumor checkpoint controller lisavanbulin. Ongoing patients will be offered continued access to lisavanbulin, whilst partnering opportunities continue to be explored.
With regard to the FGFR inhibitor derazantinib, the company has decided to terminate the license agreement and return the rights to Merck & Co, Inc. by the end of the year.1

  1. Basilea has in-licensed derazantinib from ArQule Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.
  2. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: June 24, 2022]
  3. ERADICATE: ClinicalTrials.gov identifier NCT03138733
    K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology. 2020 (1), 35-48
  4. Basilea's ceftobiprole phase 3 program is funded in part (up to USD 134.2 million, which is approximately 70% of the total potential program costs) with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C.
  5. A. G. Jensen, C. H. Wachmann, F. Espersen et al. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Archives of Internal Medicine 2002 (162), 25-32
  6. J.-L. Wang, S.-Y. Chen, J.-T. Wang et al. Comparison of both clinical features and mortality risk associated with bacteremia due to community-acquired methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical Infectious Diseases 2008 (46), 799-806
  7. S. I. Blot, K. H. Vandewoude, E. A. Hoste et al. Outcome and attributable mortality in critically ill patients with bacteremia involving methicillin-susceptible and methicillin-resistant Staphylococcus aureus. Archives of Internal Medicine 2002 (162), 2229-2235
  8. S. E. Cosgrove, G. Sakoulas, E. N. Perencevich et al. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59

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