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Ceftobiprole

 
 

Ceftobiprole: a broad-spectrum i.v. antibiotic Ceftobiprole is a cephalosporin antibiotic for i.v. administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.

The drug is approved for sale in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1

Ceftobiprole is currently marketed in key European countries, Canada and Argentina, and Basilea has entered into license and distribution agreements for the drug in Europe, Latin America, China, the Middle East and North Africa (MENA) region, Canada and Israel.

Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the FDA for the potential treatment of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Basilea reached agreement with the FDA on Special Protocol Assessments for two cross-supportive phase 3 studies, one in SAB and one in ABSSSI, aiming at regulatory approval of the drug in the United States. The ABSSSI study has started early 2018 and Basilea anticipates commencing patient enrollment in the SAB study by mid-2018. The phase 3 program is funded in part (up to USD 118 million, which is approximately 70% of the total estimated 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 No. HHSO100201600002C.

About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired infections and has been shown to have among the highest mortality rates of all hospital-acquired infections.2 Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most frequent causes of hospital-acquired pneumonia.3 Community-acquired pneumonia (CAP) is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.4 Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is considered a best medical practice. The increasing incidence of bacteria resistant to many established antibiotics is a major concern.
 
About MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) is a Gram-positive bacterium and an important cause of pneumonia, accounting for more than 20% of HAP cases.5 It is one of the most important causes of antibiotic-resistant healthcare-associated infections worldwide.6 With MRSA rates remaining above 25% in seven of the 30 reporting European Union/European Economic Area countries and a populations-weighted mean of 17.8%, the ECDC considers MRSA a public health priority.6 In the US, MRSA was assigned "threat level serious" by the US Centers for Disease Control and Prevention (CDC). For 2011, the CDC reported that approximately 80,000 invasive MRSA infections occurred in the US, resulting in 11,000 deaths.7

References

  1. U.K. Summary of Product Characteristics (SPC)
  2. C. Rotstein et al. Clinical practice guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases & Medical Microbiology 2008 (19), 19-53
  3. R. N. Jones. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87
  4. W. I. Sligl et al. Severe community-acquired pneumonia. Critical Care Clinics 2013 (29), 563-601
  5. E. Rubinstein et al. Pneumonia caused by methicillin-resistant Staphylococcus aureus. Clinical Infectious Diseases 2008 (46), Suppl 5, S378-S385
  6. European Centre for Disease Prevention and Control. Antimicrobial resistance surveillance in Europe 2012. Annual Report of the European Antimicrobial Resistance Surveillance Network (EARS-Net). ECDC 2013
  7. US Centers for Disease Control and Prevention (CDC). Antibiotic resistance threats in the United States, 2013. [Accessed September 26, 2016]
 
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Basilea is member of the BEAM (Biotech companies in Europe combating AntiMicrobial Resistance) Alliance
 
IDSA – Infectious
Diseases Society of America