CABP

Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024

Retrieved on: 
Friday, May 3, 2024
Infection, Kidney, FDA, Administration, Staphylococcus, ASPR, HHS, SAB, Safety, Ceftobiprole, Methicillin-resistant Staphylococcus aureus, Food, Ceftriaxone, ESCMID, Daptomycin, Partnership, Fungal infection, Development, CABP, TARGET, ABSSSI, Patient, Staphylococcus aureus, Dialysis, Bronchopneumonia, MRSA, Vaccine

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.

Key Points: 
  • 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).
  • 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 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.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Basilea provides portfolio status update

Retrieved on: 
Friday, January 5, 2024
European Commission, Partnership, Yeast, ABSSSI, Fungus, FDA, Antifungal, PDUFA, DXR, WHO, European, Staphylococcus aureus, Genetically modified bacteria, NDA, Bronchopneumonia, SAB, Civil service commission, USD, Infection, Candida auris, Fungal infection, World Health Organization, Biofilm, Patient, Staphylococcus, CABP, Pharmaceutical industry

By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.

Key Points: 
  • By year-end 2023, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan.
  • In August, Basilea submitted a similar application for a pediatric label extension of Cresemba in the European Union and anticipates a decision by the European Commission around mid-2024.
  • Basilea expects to enter into a commercialization partnership agreement for ceftobiprole in the US prior to the FDA decision.
  • For fosmanogepix, Basilea anticipates to start a phase 3 study in invasive yeast infections mid-2024 and a phase 3 study in invasive mold infections, by year-end 2024.

Paratek Pharmaceuticals Announces Inclusion of Oral NUZYRA® in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, December 13, 2023
Food, ABSSSI, Bronchopneumonia, NMPA, Public, NRDL, Patient, Safety, CABP, Pharmaceutical industry

Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.

Key Points: 
  • Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.
  • “The addition of oral NUZYRA to China’s NRDL allows millions of patients increased accessibility, at reduced prices, to the once-daily oral and IV formulations of this life-saving therapy for serious community-acquired infections,” said Evan Loh, M.D., Paratek chief executive officer.
  • “This inclusion further expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis.
  • Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.

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.

Gurnet Point Capital and Novo Holdings A/S Complete Acquisition of Paratek Pharmaceuticals, Inc.

Retrieved on: 
Thursday, September 21, 2023
CVR, Bronchopneumonia, Public, Calendar, CABP, ABSSSI, Acquisition, Novo Holdings A/S, Gurnet Point, Massachusetts, Novo Nordisk Foundation, Contingent value rights, Pharmaceutical industry

CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Gurnet Point Capital (“Gurnet Point”) and Novo Holdings A/S (“Novo Holdings”) announced today the completion of their acquisition of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”) (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel therapies for life-threatening diseases and other public health threats.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Gurnet Point Capital (“Gurnet Point”) and Novo Holdings A/S (“Novo Holdings”) announced today the completion of their acquisition of Paratek Pharmaceuticals, Inc. (“Paratek” or the “Company”) (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel therapies for life-threatening diseases and other public health threats.
  • “Today’s completion of the acquisition of Paratek by Gurnet Point and Novo Holdings represents the beginning of a new chapter in our Company’s history,” said Evan Loh, M.D., Chief Executive Officer at Paratek.
  • Under the terms of the merger agreement, Gurnet Point, a leading healthcare investment firm, and Novo Holdings, a holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, acquired all outstanding shares of Paratek for approximately $462 million, including the assumption of debt and assuming full payment of a CVR.
  • Stockholders approved the merger agreement proposal at Paratek's special meeting of stockholders on September 18, 2023 in connection with the previously announced definitive agreement between the Company, Gurnet Point and Novo Holdings.

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.

Clarametyx Announces Positive Early Phase 1 Safety Findings on CMTX-101, Immune-Enabling Antibody Therapy

Retrieved on: 
Thursday, June 1, 2023
Biotechnology, Pharmaceutical, Health, Infection, Pharmacokinetics, CABP, Completeness, Biofilm, Patient, Safety, Vaccine

(“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced positive initial safety data from the Phase 1a portion of its clinical development program for CMTX-101, a novel immune-enabling antibody therapy designed to treat serious bacterial infections, with no safety concerns identified.

Key Points: 
  • (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced positive initial safety data from the Phase 1a portion of its clinical development program for CMTX-101, a novel immune-enabling antibody therapy designed to treat serious bacterial infections, with no safety concerns identified.
  • “Clearing the safety hurdle in Phase 1 is a validating milestone for accelerating development of this potentially important new tool to address persistent bacterial infections,” said David Richards, Chief Executive Officer, Clarametyx.
  • Additional study details and eligibility criteria can be found at www.clinicaltrials.gov , NCT05629741 .
  • Complete data from the Phase 1 portion of the study are expected in early 2024.