Ceftobiprole

Basilea announces US FDA approval of antibiotic ZEVTERA® (ceftobiprole medocaril) for three indications

Retrieved on: 
Thursday, April 4, 2024
Disease, MSSA, MRSA, Development, TARGET, Associate, Partnership, CABP, New Drug Application, Patient, HHS, Mortality, NDA, Fungal infection, Staphylococcus aureus, Bronchopneumonia, Infection, Safety, SAB, ASPR, Staphylococcus, Ceftobiprole, Administration, FDA, ABSSSI, Pharmaceutical industry

David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.

Key Points: 
  • David Veitch, Chief Executive Officer of Basilea, said: “We are excited with the US approval of ZEVTERA.
  • The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US.
  • This approval is a landmark for ceftobiprole and reflects its broad clinical utility.
  • 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.

Basilea reports strong 2023 full-year results with profitability significantly above guidance, whilst substantially expanding the R&D portfolio

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Isavuconazonium, Investment, FDA, Growth, Ceftobiprole, PDUFA, CHF, Patient, Acceleration, FY, Research, Partnership

53 LR

Key Points: 
  • 53 LR
    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 its results for the financial year ended December 31, 2023.
  • Our strong financial prospects are reflected in our guidance for 2024, which assumes continued significant top line and bottom line growth.
  • Basilea recorded an operating profit of CHF 19.2 million (FY 2022: CHF 18.5 million), which is 28% above guidance.
  • In 2023, a positive net cash flow of CHF 14.2 million was provided by operating activities, twice as much as in the previous year (FY 2022: CHF 7.1 million).

Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

Retrieved on: 
Tuesday, October 17, 2023
Efficacy, Staphylococcus, Methicillin-resistant Staphylococcus aureus, Ambrose, Abstract, Treatment, Clinical, Circulatory system, MRSA, Biomedical Advanced Research and Development Authority, BARDA, Enterococcus faecalis, Infection, ASPR, MSSA, IDSA, Isolates, Laboratory, Liolios Xirolivaditis, Staphylococcus aureus, PK/PD models, SAB, ABSSSI, CABP, Bronchopneumonia, Administration for Strategic Preparedness and Response, Streptococcus pneumoniae, Prescription Drug User Fee Act, Duke University School of Medicine, Infectious Diseases Society of America, Randomness, Development, Administration, Safety, Patient, PDUFA, HHS, Pharmaceutical industry, Vaccine, Ceftobiprole, Litherland, Enterococcus, Allschwil, Streptococcus, Bloodstream infections

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.
  • It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies.
  • Abstract #1946 – In Vitro Activity of Ceftobiprole against Staphylococcus aureus Bacteremia Isolates from the United States (2018–2020) – L. Duncan, M. Castanheira, J. I.
  • Smart, M. E. Jones, P. G. Ambrose, K. Litherland
    Abstract #2561 – Population Pharmacokinetic Analyses for Ceftobiprole Using Data from Phase 1 and 3 Studies – A. P. Cammarata, K. Litherland, M. C. Safir, S. M. Bhavnani, M. Saulay, J. I.

Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole

Retrieved on: 
Monday, October 2, 2023
SAB, ASPR, US Foods, Prescription Drug User Fee Act, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, PDUFA, Infection, Fungal infection, FDA, Safety, BARDA, TARGET, Pharmaceutical industry, Allschwil, New Drug Application

Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024

Key Points: 
  • Prescription Drug User Fee Act (PDUFA) goal date set for April 03, 2024
    Ad hoc announcement pursuant to Art.
  • 53 LR
    Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the antibiotic ceftobiprole, which was submitted to the FDA on August 3rd this year.
  • The FDA has set April 03, 2024, as the Prescription Drug User Fee Act (PDUFA) goal date.
  • Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the PDUFA goal date.

Basilea announces New England Journal of Medicine publication of phase 3 data on ceftobiprole for the treatment of Staphylococcus aureus bacteremia

Retrieved on: 
Thursday, September 28, 2023
SAB, ASPR, Staphylococcus, The New England Journal of Medicine, US Foods, Biomedical Advanced Research and Development Authority, Microbiology, MSSA, HHS, Clostridioides, Daptomycin, Overalls, Infection, Survival, MRSA, Administration for Strategic Preparedness and Response, Duke University School of Medicine, Associate, Staphylococcus aureus, Ceftobiprole, NEJM, ABSSSI, Clostridioides difficile infection, Administration, Development, Patient, Fungal infection, Disease, Mortality, Bacteria, BARDA, Food, Methicillin-resistant Staphylococcus aureus, New Drug Application, Pharmaceutical industry, Vaccine, Allschwil, Medicine

ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.

Key Points: 
  • ERADICATE is the largest registrational study for SAB conducted to date and ceftobiprole showed similar clinical benefit compared to daptomycin, which is a standard of care antibiotic in the treatment of SAB.
  • Using a pre-defined non-inferiority margin of 15%, treatment with ceftobiprole was non-inferior to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group.
  • The results for the primary study outcome were consistent in key subgroups, including patients with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA).
  • Ceftobiprole was generally well tolerated and showed a safety profile consistent with previous phase 3 studies and the post-marketing experience.

Basilea reports strong revenue and profit growth in first half-year 2023

Retrieved on: 
Tuesday, August 15, 2023
US Foods, New Drug Application, LR, NDA, Research, Ceftobiprole, Acquisition, Patient, Growth, CHF, Food, Pharmaceutical industry, Cryptocurrency, Allschwil, Isavuconazonium

David Veitch, Chief Executive Officer, stated: “We made very good progress on the implementation of our growth strategy, which is reflected in our strong financial performance, with a 57 percent growth year-on-year in Cresemba and Zevtera related revenue.

Key Points: 
  • David Veitch, Chief Executive Officer, stated: “We made very good progress on the implementation of our growth strategy, which is reflected in our strong financial performance, with a 57 percent growth year-on-year in Cresemba and Zevtera related revenue.
  • We are also in discussions with regard to the in-licensing or acquisition of a number of novel, differentiated anti-infective assets, to complement our pipeline and support long-term growth.
  • In H1 2023, research and development expenses decreased by 42% to CHF 21.5 million (H1 2022: CHF 37.1 million).
  • In H1 2023, an operating profit of CHF 36.9 million was recorded (H1 2022: operating loss of CHF 10.0 million) as well as a net profit of CHF 31.8 million (H1 2022: net loss of CHF12.2 million).

Basilea announces submission of a New Drug Application to the US Food and Drug Administration for its antibiotic ceftobiprole

Retrieved on: 
Friday, August 4, 2023
SAB, Infection, ASPR, Priority review, US Foods, Partnership, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, Methicillin-resistant Staphylococcus aureus, MRSA, Administration for Strategic Preparedness and Response, LR, NDA, CABP, Fungal infection, Ceftobiprole, ABSSSI, GAIN, Administration, Development, Patient, Disease, Mortality, FDA, Safety, BARDA, TARGET, Food, Pharmaceutical industry, Vaccine, Allschwil, Basel

The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.

Key Points: 
  • The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole.
  • Provided that the NDA submission is accepted, Basilea expects a decision by the FDA on the NDA in the second quarter of 2024.
  • Basilea plans to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the FDA’s decision on the NDA.
  • 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.

Basilea provides update on New Drug Application to the US Food and Drug Administration for antibiotic ceftobiprole

Retrieved on: 
Tuesday, April 18, 2023
SAB, ASPR, US Foods, Biomedical Advanced Research and Development Authority, HHS, QIDP, Bronchopneumonia, New Drug Application, Administration for Strategic Preparedness and Response, NDA, LR, CMOS, CABP, Staphylococcus, USD, Ceftobiprole, ABSSSI, Administration, Development, Patient, FDA, BARDA, Food, Pharmaceutical industry

53 LR

Key Points: 
  • 53 LR
    Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, provided an updated timeline for its New Drug Application (NDA) submission for its antibiotic ceftobiprole to the US Food and Drug Administration (FDA).
  • Basilea, therefore, now expects to submit the NDA for the three indications of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in the third quarter of 2023.
  • David Veitch, Basilea’s CEO, said: “We have compiled our NDA dossier and are ready to make a submission to the FDA.
  • However, after completion of the FDA inspection-readiness preparations within our supply chain, it became clear that the quality systems of one of our CMOs need to be adapted prior to an FDA inspection.

Basilea reports strong financial results 2022 based on successful implementation of new strategy

Retrieved on: 
Tuesday, February 14, 2023
Fungal infection, LR, Investment, Bronchopneumonia, Patient, BARDA, Research, CHF, ISIN, Ceftobiprole, Staphylococcus aureus, Staphylococcus, FGFR, Partnership, Growth, Pharmaceutical industry, Cryptocurrency, Isavuconazonium

53 LR

Key Points: 
  • 53 LR
    Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, announced today its results for the financial year ended December 31, 2022.
  • Our commercial-stage anti-infectives brands made great progress in 2022 and are well positioned to continue their success story in 2023 and beyond.
  • In addition, we have significantly reduced our debt level in 2022, whilst avoiding dilution for our shareholders.
  • Our strong financial prospects are reflected in our 2023 financial guidance.

Basilea reports preliminary 2022 revenues, exceeding guidance, and provides portfolio update

Retrieved on: 
Wednesday, January 11, 2023
Cryptococcosis, SAB, CLK, TARGET, Merck, New Drug Application, Staphylococcus aureus, FGFR, Regulation of tobacco by the U.S. Food and Drug Administration, Aspergillosis, CHF, PARG, DXR, Mucormycosis, Marketing, BARDA, Growth, Food, Subclinical infection, Patient, Research, ABSSSI, Glioblastoma, Gram-negative bacteria, Ceftobiprole, LR, Pharmaceutical industry, Vaccine, Isavuconazonium, EU

CHF 122 million, exceeding guidance by more than 17%

Key Points: 
  • CHF 122 million, exceeding guidance by more than 17%
    Ad hoc announcement pursuant to Art.
  • Revenue contributions from the antifungal Cresemba and the antibiotic Zevtera are expected to amount to approximately CHF 122 million (full-year 2022 guidance: CHF 98 million – 104 million).
  • David Veitch, Chief Executive Officer, commented: “We achieved significant milestones in 2022 and will continue to focus on delivering on our strategy to drive value creation going forwards.
  • By November 2022, Basilea had entered into three separate transactions with innovative oncology companies.