ABSSSI

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.

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Diarrhea, Marketing, INN, Infection, Woman, Allergy, ABSSSI, ATC, Pneumonia, Aztreonam, Skin, International, Nausea, Language, Tissue, DNA, Mouth, Vancomycin, Community-acquired pneumonia, Antimicrobial spectrum, CAP, Quinolone antibiotic, Breastfeeding, European Medicines Agency, Tablet, Select, Patient, Birth, Bacteria, Anatomy, Moxifloxacin, IIA, Meglumine, Medical device

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 6, Status: Authorised

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.

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.

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.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

Retrieved on: 
Friday, September 22, 2023
Priority review, Food and Drug Administration Safety and Innovation Act, Innovation Act, IV, Prevalence, Amputation, Diabetes, QIDP, Methicillin, S. aureus, Methicillin-resistant Staphylococcus aureus, Infection, Act, MRSA, NDA, Fast Track, Osteomyelitis, ABSSSI, GAIN, Diabetic foot infection, Patient, Ulcer, Disease, DFI, Mortality, Toxic shock syndrome, Bacteria, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, Food, Pharmaceutical industry, FDASIA

Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.

Key Points: 
  • Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI.
  • Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
  • With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA).
  • "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations."