Allschwil, Switzerland, May 03, 2024
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage
biopharmaceutical company committed to meeting the needs of patients with severe
bacterial and fungal infections, announced today that scientific presentations
with new data on its antibiotic ceftobiprole (Zevtera(®)) have been presented at
ESCMID Global 2024, the annual meeting of the European Society of Clinical
Microbiology and Infectious Diseases, which took place from April 27 to
30, 2024 in Barcelona, Spain.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: "The data
presented at ESCMID Global 2024 provide further evidence for the differentiated
profile of ceftobiprole in the treatment of severe bacterial bloodstream
infections, including those involving methicillin-resistant Staphylococcus
aureus, MRSA, and pulmonary infections."
Ceftobiprole was recently approved by the US Food and Drug Administration (FDA),
supported by data from three phase 3 studies: ERADICATE, conducted in patients
with Staphylococcus aureus bacteremia (SAB), TARGET, in acute bacterial skin and
skin structure infections (ABSSSI), and a study in community-acquired bacterial
pneumonia (CABP).(1, 2, )(3)
Additional data from the ERADICATE phase 3 study were presented in three
posters, comparing ceftobiprole to daptomycin in the treatment of complicated
Staphylococcus aureus bacteremia. One poster focused on subgroup analyses in
patients with renal impairment, demonstrating consistent efficacy and safety of
ceftobiprole in this specific patient group, which included patients with
chronic dialysis, representing 13% of patients in the ERADICATE study.
Furthermore, baseline characteristics of patients in the ERADICATE study were
presented, underlining the complexity of the infections in the studied patient
population, with about 30% of patients presenting with more than one underlying
infectious condition, foci, or complications at baseline, including soft tissue
infections, dialysis, abdominal and thoracic abscesses, osteoarticular
infections and right-sided endocarditis. Data presented on a third poster
demonstrated that bloodstream clearance was achieved at a median of four days
after the start of treatment in both the ceftobiprole and comparator groups. In
the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-
positive blood cultures after ten days compared to the comparator treatment
group.
An oral presentation focused on a re-analysis of the previously conducted
ceftobiprole phase 3 study in patients with community-acquired bacterial
pneumonia (CABP). The study compared ceftobiprole with ceftriaxone ± linezolid
and was performed prior to the availability of the current FDA guidance for the
development of drugs for the treatment of CABP (FDA-CABP-2020). Using the FDA-
CABP-2020 primary endpoint of early clinical success at day 3 after study start,
this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ±
linezolid.
Basilea's phase 3 program for ceftobiprole is funded in part with federal funds
from the US Department of Health and Human Services (HHS); Administration for
Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and
Development Authority (BARDA), under contract number HHSO100201600002C. Through
this partnership, Basilea has been awarded approximately USD 112 million, or
approximately 75 percent of the costs related to the SAB and ABSSSI phase 3
studies, regulatory activities and non-clinical work.
Ceftobiprole data presented at ESCMID Global 2024

   Poster P0769 / Abstract 1493 - Ceftobiprole is safe and efficacious in
   treating renally impaired patients with complicated Staphylococcus aureus
   Bacteremia (SAB), including those on dialysis - results from the ERADICATE
   Phase 3 study - M. Engelhardt, S. E. Cosgrove, S. B. Doernberg,
   T. C. Jenkins, N. A. Turner, H. W. Boucher, M. Jones, D. Ionescu, J. Smart,

- M. Saulay, V. G. Fowler, Jr

   Poster P0771 / Abstract 1559 - An analysis of baseline conditions or
   complications of S. aureus bacteremia from a double-blind randomized Phase
   3 study (ERADICATE) comparing ceftobiprole versus daptomycin -
   T. L. Holland, S. E. Cosgrove, S. B. Doernberg, T. C. Jenkins, N. A. Turner,
   H. W. Boucher, M. Jones, D. Ionescu, J. Smart, M. Saulay, M. Engelhardt,

- V. G. Fowler, Jr

   Poster P0774 / Abstract 1577 - Comparison of ceftobiprole versus daptomycin
   for time to S. aureus bloodstream clearance in the recent double-blind
   randomized Phase 3 study (ERADICATE) - T. L. Holland, S. E. Cosgrove,
   S. B. Doernberg, T. C. Jenkins, N. A. Turner, H. W. Boucher, M. Jones,

- D. Ionescu, J. Smart, M. Saulay, M. Engelhardt, V. G. Fowler, Jr

   Abstract O1068 - Ceftobiprole versus ceftriaxone ± linezolid in community-
   acquired bacterial pneumonia (CABP): Re-analysis of a Phase 3 study
   according to the FDA-CABP-2020 guidance - T. Welte, M. Engelhardt, M. Jones,

- S. Friedmann, D. Ionescu, M. Saulay, J. Smart, A. Shorr
About Zevtera(®) (ceftobiprole medocaril sodium for injection)
Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an
advanced generation cephalosporin antibiotic for intravenous administration,
with rapid bactericidal activity against a wide range of Gram-positive bacteria,
such as Staphylococcus aureus, including methicillin-resistant strains (MRSA),
and Gram-negative bacteria.(4) In several countries in Europe and beyond, the
brand is currently approved and marketed as Zevtera(®) and Mabelio(®) for the
treatment of adult patients with hospital-acquired bacterial pneumonia (HABP),
excluding ventilator-associated bacterial pneumonia (VABP), and for the
treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered
into license and distribution agreements covering more than 80 countries. In the
United States, ZEVTERA(®) is indicated for the treatment of adult patients with
Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including
right-sided infective endocarditis, and adult patients with acute bacterial skin
and skin structure infections (ABSSSI) and for adult and pediatric patients (3
months to less than 18 years old) with community-acquired bacterial pneumonia
(CABP).
Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for
injection)
Contraindications
ZEVTERA is contraindicated in patients with a known history of severe
hypersensitivity to ZEVTERA, or to other members of the cephalosporin class.
Warnings and precautions

  * Increased Mortality with Unapproved use in Ventilator-Associated Bacterial
    Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the
    treatment of VABP has not been established and the use of ZEVTERA for VABP
    is not approved.
  * Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity
    reaction occurs, and institute appropriate treatment.
  * Seizures and other adverse central nervous system (CNS) reactions have been
    associated with the use of ZEVTERA. If seizures or other CNS adverse
    reactions occur, evaluate patients to determine whether ZEVTERA should be
    discontinued.
  * Clostridioides difficile-associated diarrhea (CDAD) has been reported with
    nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if
    diarrhea occurs.

Adverse reactions
* SAB (adult patients): The most common adverse reactions occurring in >= 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme
and bilirubin increased, diarrhea, blood creatinine increased, hypertension,

    leukopenia and pyrexia.
  * ABSSSI (adult patients): The most common adverse reactions occurring in >=
    2% of adult patients were nausea, diarrhea, headache, injection site
    reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia.
  * CABP (adult and pediatric patients 3 months to less than 18 years of age):
      * Adult Patients: The most common adverse reactions occurring in >= 2% of
        adult patients were nausea, hepatic enzyme increased, vomiting,
        diarrhea, headache, rash, insomnia, abdominal pain, phlebitis,
        hypertension and dizziness.

* Pediatric Patients: The most common adverse reactions occurring in >= 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia.
For full US prescribing information, please visit here:
https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk
About Staphylococcus aureus bacteremia (SAB)
Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection
associated with significant morbidity and mortality.(5) Complications include
concomitant infections such as bone, joint or heart valve infections, persistent
bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause
mortality of around 20%, there is a high medical need for improved therapies for
SAB.(6)
About acute bacterial skin and skin structure infections (ABSSSI)
Acute bacterial skin and skin structure infections (ABSSSI) are common
infections in the healthcare setting. Staphylococcus aureus is the most common
pathogen associated with these infections, which can be difficult to treat if
methicillin-resistant Staphylococcus aureus (MRSA) is involved.(7)
About community-acquired bacterial pneumonia (CABP)
Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity
and mortality worldwide. It is the leading cause of infectious disease-related
death in the US.(8)
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and
headquartered in Switzerland. We are committed to discovering, developing and
commercializing innovative drugs to meet the needs of patients with severe
bacterial and fungal infections. We have successfully launched two hospital
brands, Cresemba for the treatment of invasive fungal infections and Zevtera for
the treatment of bacterial infections. In addition, we have preclinical and
clinical anti-infective assets in our portfolio. Basilea is listed on the SIX
Swiss Exchange (SIX: BSLN). Please visit basilea.com (https://www.basilea.com/).
Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements, such as "believe", "assume", "expect", "forecast", "project", "may",
"could", "might", "will" or similar expressions concerning Basilea Pharmaceutica
Ltd, Allschwil and its business, including with respect to the progress, timing
and completion of research, development and clinical studies for product
candidates. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results, financial
condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil
to be materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Basilea Pharmaceutica
Ltd, Allschwil is providing this communication as of this date and does not
undertake to update any forward-looking statements contained herein as a result
of new information, future events or otherwise.
For further information, please contact:
Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd, Allschwil
Hegenheimermattweg 167b
4123 Allschwil
Switzerland

 Phone  +41 61 606 1102
        media_relations@basilea.com (mailto:media_relations@basilea.com)

E-mail investor_relations@basilea.com (mailto:investor_relations@basilea.com)
This press release can be downloaded from www.basilea.com
(http://www.basilea.com).
References
1. ERADICATE study (SAB): ClinicalTrials.gov identifier NCT03138733

    T. L. Holland, S. E. Cosgrove, S. B. Doernberg et al. Ceftobiprole for
    treatment of complicated Staphylococcus aureus bacteremia. New England
    Journal of Medicine 2023 (389), 1390-1401; DOI: 10.1056/NEJMoa2300220

2. TARGET study (ABSSSI): ClinicalTrials.gov identifier NCT03137173

    J. S. Overcash, C. Kim, R. Keech 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

3. CABP study: ClinicalTrials.gov identifier NCT00326287

    S. C. Nicholson, T. Welte, T. M. File Jr. et al. A randomised, double-blind
    trial comparing ceftobiprole medocaril with ceftriaxone with or without
    linezolid for the treatment of patients with community-acquired pneumonia
    requiring hospitalization. International Journal of Antimicrobial Agents
    2012 (39), 240-246

4. Summary of Product Characteristics (SmPC) Zevtera:
https://www.medicines.org.uk/emc/product/9164/smpc (Accessed: May 02, 2024)
5. A. P. Kourtis, K. Hatfield, J. Baggs et al. Vital signs: Epidemiology and

    recent trends in methicillin-resistant and in methicillin-susceptible
    Staphylococcus aureus bloodstream infections - United States. Morbidity and
    Mortality Weekly Report 2019 (68), 214-219

6. 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

7. J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions
for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518
8. J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with

    pneumonia in the United States: Incidence, epidemiology, and mortality.
    Clinical Infectious Diseases 2017 (65), 1807-1812

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