Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023
- Eight presentations on antibiotic ceftobiprole providing further evidence for its activity against methicillin-resistant Staphylococcus aureus (MRSA) and other clinically relevant pathogens
Allschwil, Switzerland, October 17, 2023
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 Infectious Disease Week (IDWeek) 2023, highlighting its utility for the treatment of severe bacterial infections.
IDWeek is the annual meeting of the Infectious Diseases Society of America (IDSA), jointly held with other infectious diseases societies in the US, and took place in Boston, Massachusetts (USA) from 11 to 15 October 2023.
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. These studies were conducted in patients with Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). These are the three indications included in our New Drug Application, which is currently under priority review with the US FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of 03 April 2024.”
Data from four presentations, building on pharmacokinetic-pharmacodynamic modeling, provided evidence that the exposure achieved with the applied dosing regimens was efficacious for the treatment of Staphylococcus aureus bacteremia (SAB) in the ERADICATE phase 3 study.1 The same was also shown in analyses for the ceftobiprole phase 3 studies in acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).2, 3
Four additional abstracts included data from large in-vitro susceptibility studies testing bacterial isolates from US patients, which confirmed that ceftobiprole exhibits potent in-vitro activity against methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA, MRSA), as well as against Streptococcus pneumoniae and Enterococcus faecalis, and retained its potency over the surveillance period of several years against these clinically relevant pathogens.
The presented data were generated in collaboration with the Institute for Clinical Pharmacodynamics, Schenectady, New York (USA), JMI Laboratories, North Liberty, Iowa, (USA) and the Duke Clinical Research Institute, Durham, North Carolina (USA).
Basilea’s ceftobiprole phase 3 program 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. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the phase 3 studies in SAB and acute bacterial skin and skin structure infections (ABSSSI), regulatory activities and non-clinical work.
|Ceftobiprole data presented at IDWeek 2023|
|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, R. E. Mendes|
|Abstract #2162 – In Vitro Antimicrobial Activity of Ceftobiprole against Streptococcus pneumoniae Isolates from the United States (2016–2020) – L. Duncan, M. Castanheira, J. I. Smart, M. E. Jones, R. E. Mendes|
|Abstract #2173 – Activity of Ceftobiprole Against Enterococcus faecalis Clinical Isolates From the United States (2016–2020), Including Those From Difficult-to-Treat Infections – R. E. Mendes, L. Duncan, H. S. Sader, J. I. Smart, M. E. Jones, M. Castanheira|
|Abstract #2530 – Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Ceftobiprole Dose Selection for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP) – S. M. Bhavnani, J. P. Hammel, A. J. Rinaldo, J. I. Smart, K. Litherland, L. Duncan, M. E. Jones, M. Engelhardt, P. G. Ambrose, C. M. Rubino|
|Abstract #2531 – Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment Analyses to Support Ceftobiprole Dosing Regimens for Patients with Staphylococcus aureus Bacteremia (SAB) – S. M. Bhavnani, J. P. Hammel, A. J. Rinaldo, J. I. Smart, K. Litherland, L. Duncan, M. E. Jones, M. Engelhardt, P. G. Ambrose, C. M. Rubino|
|Abstract #2532 – Pharmacokinetic-Pharmacodynamic Analyses for Ceftobiprole Efficacy Based on Phase 3 Data from Patients with Staphylococcus aureus Bacteremia – S. M. Bhavnani, J. P. Hammel, K. Liolios, A. P. Cammarata, M. Saulay, C. M. Rubino, M. Engelhardt, 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. Smart, M. E. Jones, M. Engelhardt, C. M. Rubino|
|Abstract #2785 - Characterization of Methicillin-resistant Staphylococcus aureus Bloodstream Isolates Recovered from Patients Enrolled in a Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole for Treatment of Bacteremia, Including Infective Endocarditis – R. E. Mendes, L. Duncan, J. H. Kimbrough, T. L. Holland, V. G. Fowler Jr, M. E. Jones, M. Engelhardt, J. I. Smart, M. Castanheira|
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 The brand is currently approved and marketed as Zevtera® and Mabelio® in several countries in Europe and beyond 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. Ceftobiprole is currently not approved or partnered in the US. Ceftobiprole was designated a Qualified Infectious Disease Product (QIDP) by the US Food and Drug Administration (FDA) for SAB, ABSSSI and CABP. Therefore, if approved, ceftobiprole would be eligible to receive ten years of market exclusivity in the US from the date of approval.
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 anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.
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
|Phone||+41 61 606 1102|
This press release can be downloaded from www.basilea.com.
- ERADICATE (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
- TARGET (ABSSSI): 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
- 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
- Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed October 16, 2023]
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
About GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire by notified
Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire by notified
Managers’ transactions9.12.2023 18:12:40 CET | Press release
December 9, 2023 Announcement no. 21 Managers’ transactions COPENHAGEN, DENMARK and BOSTON, MA, December 9, 2023, (GLOBE NEWSWIRE) – BioPorto A/S (BioPorto or the Company) (CPH:BIOPOR), has received notice pursuant to article 19 of Regulation (EU) no. 596/2014 of the below transaction related to shares in BioPorto made by persons discharging managerial responsibilities in BioPorto and/or persons closely related with them. 1. Details of the person discharging managerial responsibilities/person closely associated a) Name Singer Asefzadeh Family Holding Trust 2. Reason for the notification a) Position/status Closely associated person to Michael S. Singer, member of the Board of Directors of BioPorto A/S b) Initial notification/amendment Initial notification 3. Details of the issuer a) Name BioPorto A/S b) LEI 5299004SWFL5JAN4W830 4. Details of the transaction(s) a) Description of the financial instrument type of instrument and Identification code Shares, ISIN code DK0011048619 b) Nature o
New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL)9.12.2023 18:00:00 CET | Press release
Media Release COPENHAGEN, Denmark; December 9, 2023 Data from the pivotal phase 1/2 EPCORE™ NHL-1 study showed 82 percent overall response rate (ORR), 63 percent complete response (CR) and 67 percent minimal residual disease (MRD) negativity in patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with subcutaneous epcoritamab Results presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition include data from an optimized step-up dosing schedule for FL patients showing meaningful reduction in risk and severity of cytokine release syndrome (CRS) Follicular lymphoma is the second most common form of non-Hodgkin’s lymphoma, is considered incurable and can be difficult to treat in the R/R setting Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) todayannounced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demo
Galapagos presents new encouraging data at ASH 2023 from ongoing CD19 CAR-T studies with GLPG5201 and GLPG51019.12.2023 18:00:00 CET | Press release
Additional safety and efficacy data further support potential of innovative, decentralized approach to CAR-T manufacturing and transformational impact on patients with severe hematologic cancersTwo poster presentations include recent data updates and additional data not included in the ASH abstracts Galapagos to host a Key Opinion Leader (KOL) event with live webcast on Sunday, 10 December 2023 at 11:00 am PT/20:00 CET Mechelen, Belgium; 9 December 2023, 18:00 CET; Galapagos NV (Euronext & NASDAQ: GLPG) topresent additional encouraging clinical data from the ongoing Phase 1/2 CD19 CAR-T studies, EUPLAGIA-1 with GLPG5201 and ATALANTA-1 with GLPG5101, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter transformation, and non-Hodgkin lymphoma (rrNHL), during two poster sessions at the 65th American Society of Hematology (ASH) Annual Meeting taking place in San Diego, from 9-12 December. “We are very pleased to share promising new data from o
New data reinforce the benefit of early preventative treatment with Roche’s Hemlibra for babies with severe haemophilia A9.12.2023 17:30:00 CET | Press release
Phase III HAVEN 7 primary data presented at ASH 2023 provide additional confidence in the favourable efficacy and safety profile of subcutaneous Hemlibra given soon after birth 1At nearly two years median follow-up in the descriptive, single-arm study, no babies experienced spontaneous bleeds requiring treatment, and all treated bleeds were as a result of trauma 1Safety results were consistent with previous studies of Hemlibra, with no new safety signals observed 1The HAVEN 7 study was developed in collaboration with the haemophilia A community, to generate additional evidence for the prophylactic treatment of infants with haemophilia A Basel, 09 December 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab) in previously untreated or minimally treated infants with severe haemophilia A without factor VIII inhibitors. Results showed that Hemlibra achieved meaningful
Bulletin from Annual General Meeting in SkiStar AB9.12.2023 16:00:00 CET | Press release
At SkiStar AB (publ)’s annual general meeting, held in Sälen on 9 December 2023, the following decisions were made. A dividend of SEK 2.60 per share was adopted. Record day 12 December 2023.Lena Apler, Fredrik Paulsson, Gunilla Rudebjer, Anders Sundström, Anders Svensson and Vegard Søraunet were re-elected to the board and Carina Åkerström was elected as new board member.Anders Sundström was re-elected chairman of the board.Board fees, including committee fees, were raised to a total of SEK 2,890,000 (2022: SEK 2,810,000). The fees shall be distributed as follows: SEK 670,000 (650,000) to the chairman of the board and SEK 310,000 (300,000) each to the other non-executive directors. Audit committee members will receive total fees of SEK 240,000 (unchanged), distributed as follows: SEK 120,000 to the committee chairman and SEK 60,000 to each of the other two members. Remuneration committee members will receive total fees of SEK 120,000 (unchanged), distributed as follows: SEK 60,000 to t