Basilea announces late breaking presentation on the

• First presentation of ERADICATE section 3 examine knowledge
• Study met its main and secondary endpoints evaluating ceftobiprole versus daptomycin with or with out aztreonam

Basel/Allschwil, Switzerland, October 13, 2022

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical firm dedicated to assembly the wants of sufferers with extreme bacterial and fungal infections, introduced at the moment that an summary on the efficiently accomplished section 3 ERADICATE examine¹, evaluating ceftobiprole in the therapy of grownup sufferers with bacterial bloodstream infections brought on by Staphylococcus aureus, (SAB), has been chosen for a late breaking oral presentation at IDWeek 2022. The ERADICATE knowledge shall be introduced by Thomas Holland, M.D., Associate Professor of Medicine at Duke University School of Medicine and Chair of the ERADICATE Data Review Committee.

IDWeek is the annual assembly of the Infectious Diseases Society of America (IDSA), collectively held with different infectious ailments societies in the U.S. and can happen in Washington, D.C. from 19 to 23 October 2022.

Positive topline outcomes of the ERADICATE examine, demonstrating non-inferiority to daptomycin, with or with out aztreonam, for the main goal, had been reported in June 2022.²

Dr. Marc Engelhardt, Chief Medical Officer, mentioned: “This will be the first comprehensive presentation of the phase 3 ERADICATE study data. The study is the largest double-blind randomized study of a new antibiotic treatment conducted in SAB, which remains an area of high unmet medical need with limited treatment options available. The positive results underline the potent activity of ceftobiprole for treating serious bacterial infections and enable us to proceed with an NDA submission of ceftobiprole in the U.S.”

Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the U.S. Food and Drug Administration (FDA) round year-end 2022.

For additional data please go to idweek.org.

About ceftobiprole

Ceftobiprole medocaril, the prodrug of the energetic moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with fast bactericidal exercise in opposition to a variety of Gram-positive and Gram-negative micro organism. This contains methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and inclined Pseudomonas spp.³ The model is at present accepted and marketed as Zevtera and Mabelio in quite a lot of international locations in Europe and past for the therapy of grownup sufferers with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the therapy of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements in Europe, Eurasian international locations, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) areas.

About the ceftobiprole section 3 program

The ERADICATE examine¹ was a randomized, double-blind, multicenter section 3 examine, which enrolled 390 sufferers with SAB. The examine in contrast the security and efficacy of intravenous ceftobiprole medocaril with intravenous daptomycin, with or with out intravenous aztreonam for protection of Gram-negative pathogens, for as much as 42 days of therapy. Patients have been enrolled at greater than 50 examine facilities in Eastern and Central Europe, Israel, Latin America, the Republic of South Africa, and the U.S.

The second examine of the program, the TARGET examine⁴, was a randomized, double-blind, multicenter section 3 examine, which enrolled 679 sufferers with acute bacterial pores and skin and pores and skin construction infections (ABSSSI) and in contrast the security and efficacy of intravenous ceftobiprole medocaril with intravenous vancomycin plus intravenous aztreonam. The examine was performed at greater than 30 scientific facilities in the U.S. and Europe.

The two section 3 research have been performed beneath Special Protocol Assessment (SPA) agreements with the U.S. FDA.

Basilea’s ceftobiprole section 3 program is funded partially (as much as USD 136.4 million, which is roughly 70% of the whole potential program prices) with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), beneath contract quantity HHSO100201600002C.

About Staphylococcus aureus bacteremia (SAB)

Staphylococcus aureus bacteremia is a number one reason for bloodstream infections, chargeable for a broad number of issues and has been related to vital morbidity and a mortality of 20 to 40%.^5, 6 Several research have demonstrated that MRSA bacteremia is related to a considerably increased mortality fee in contrast with MSSA bacteremia.^7, 8 Infections of the inside lining of the coronary heart or coronary heart valves (infective endocarditis) and bone infections (osteomyelitis) are frequent issues of SAB.

About Basilea

Basilea is a commercial-stage biopharmaceutical firm based in 2000 and headquartered in Switzerland. We are dedicated to discovering, creating and commercializing progressive medicine to fulfill the wants of sufferers with extreme bacterial and fungal infections. We have efficiently launched two hospital manufacturers, Cresemba for the therapy of invasive fungal infections and Zevtera for the therapy of bacterial infections. In addition, we’ve a number of preclinical anti-infective property in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please go to basilea.com.

Disclaimer

This communication expressly or implicitly comprises sure forward-looking statements, corresponding to “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or comparable expressions regarding Basilea Pharmaceutica Ltd and its business, together with with respect to the progress, timing and completion of analysis, growth and scientific research for product candidates. Such statements contain sure recognized and unknown dangers, uncertainties and different components, which may trigger the precise outcomes, monetary situation, efficiency or achievements of Basilea Pharmaceutica Ltd to be materially totally different from any future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd is offering this communication as of this date and doesn’t undertake to replace any forward-looking statements contained herein on account of new data, future occasions or in any other case.

For additional data, please contact:

This press launch may be downloaded from www.basilea.com.

References

1. ERADICATE: ClinicalTrials.gov identifier NCT03138733
   Okay. 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
2. Basilea advert hoc announcement: Basilea announces optimistic outcomes of section 3 ERADICATE examine with ceftobiprole in Staphylococcus aureus bacteremia (SAB). June 28, 2022: https://www.basilea.com/news#news_1371 
3. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: October 12, 2022]
4. TARGET: ClinicalTrials.gov identifier NCT03137173
   J. S. Overcash, C. Kim, R. Keech R et al. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clinical Infectious Diseases 2021 (73), e1507-e1517
5. A. G. Jensen, C. H. Wachmann, F. Espersen et al. Treatment and end result of Staphylococcus aureus bacteremia: a potential examine of 278 instances. Archives of Internal Medicine 2002 (162), 25-32
6. J.-L. Wang, S.-Y. Chen, J.-T. Wang et al. Comparison of each scientific options and mortality threat related to bacteremia attributable to community-acquired methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical Infectious Diseases 2008 (46), 799-806
7. S. I. Blot, Okay. H. Vandewoude, E. A. Hoste et al. Outcome and attributable mortality in critically ailing sufferers 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 related to methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59