La Jolla Pharmaceutical Company
Biotechnology subsidiary focused on development, regulatory approval, and commercialization of therapies for critical care and infectious disease. Core activities include global clinical development (including registrational Phase 3 programs), medical and scientific communications, regulatory submissions and designation management, microbiological surveillance and susceptibility testing, pharmacometrics and PK/PD analyses, and commercialization for hospital and specialty markets.
Industries
Nr. of Employees
small (1-50)
La Jolla Pharmaceutical Company
Products
Intravenous sulbactam/durlobactam co-pack (pathogen-targeted for Acinetobacter HABP/VABP)
Co-packaged intravenous combination of a β-lactam antibacterial and a β-lactamase inhibitor indicated for treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter isolates in adults.
Advanced-generation cephalosporin antibiotic (ceftobiprole) — U.S. marketed indications
Intravenous cephalosporin antibiotic approved for multiple indications including bloodstream infections, skin and skin structure infections, and community-acquired bacterial pneumonia; includes activity against MRSA and select Gram-negative pathogens.
Intravenous tetracycline-class antibacterial (eravacycline) for complicated intra-abdominal infections
Intravenous tetracycline-class antibiotic indicated for treatment of complicated intra-abdominal infections in adults, with in vitro activity against multidrug-resistant pathogens.
Investigational single-dose oral spiropyrimidinetrione-class antibiotic for uncomplicated gonorrhea
Investigational single-dose oral antibiotic with a novel mechanism targeting bacterial type II topoisomerase, developed for treatment of uncomplicated gonorrhea; demonstrated non-inferiority in a global Phase 3 trial and has an FDA NDA accepted for review.
Intravenous sulbactam/durlobactam co-pack (pathogen-targeted for Acinetobacter HABP/VABP)
Co-packaged intravenous combination of a β-lactam antibacterial and a β-lactamase inhibitor indicated for treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter isolates in adults.
Advanced-generation cephalosporin antibiotic (ceftobiprole) — U.S. marketed indications
Intravenous cephalosporin antibiotic approved for multiple indications including bloodstream infections, skin and skin structure infections, and community-acquired bacterial pneumonia; includes activity against MRSA and select Gram-negative pathogens.
Intravenous tetracycline-class antibacterial (eravacycline) for complicated intra-abdominal infections
Intravenous tetracycline-class antibiotic indicated for treatment of complicated intra-abdominal infections in adults, with in vitro activity against multidrug-resistant pathogens.
Investigational single-dose oral spiropyrimidinetrione-class antibiotic for uncomplicated gonorrhea
Investigational single-dose oral antibiotic with a novel mechanism targeting bacterial type II topoisomerase, developed for treatment of uncomplicated gonorrhea; demonstrated non-inferiority in a global Phase 3 trial and has an FDA NDA accepted for review.
Services
Preparation and dissemination of peer-reviewed publications, conference presentations, educational resources for healthcare professionals, and medical information contact services.
End-to-end clinical program support including protocol design, global site management, patient recruitment and statistical analysis for registrational programs.
Commercial planning, launch execution and specialty distribution for critical-care and infectious disease product portfolios, including market access and sales operations.
Preparation and dissemination of peer-reviewed publications, conference presentations, educational resources for healthcare professionals, and medical information contact services.
End-to-end clinical program support including protocol design, global site management, patient recruitment and statistical analysis for registrational programs.
Commercial planning, launch execution and specialty distribution for critical-care and infectious disease product portfolios, including market access and sales operations.
Expertise Areas
- Clinical trial management for registrational studies (Phase 3)
- Antibacterial and pathogen-targeted drug development
- Pharmacokinetics, pharmacometrics and PK/PD modeling
- Clinical pharmacology and drug–drug interaction evaluation
Key Technologies
- Randomized controlled trial design (Phase 3, non-inferiority)
- Population pharmacokinetic (PPK) modeling
- PK/PD target-attainment analyses
- In vitro antimicrobial susceptibility testing
News & Updates
Results from the pivotal Phase 3 ATTACK trial comparing a β-lactam/β-lactamase inhibitor combination versus colistin for serious infections due to Acinetobacter were published.
U.S. FDA approved an intravenous β-lactam/β-lactamase inhibitor co-pack for treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter isolates; product became available in the U.S.
A global Phase 3 trial of an investigational single-dose oral antibiotic demonstrated non-inferiority to a standard-of-care injectable/combination regimen and met its primary endpoint; data were announced in a press release and presented at scientific meetings.
Presentation of the pivotal Phase 3 oral antibiotic trial data and multiple posters covering safety, PK/DDI and antimicrobial susceptibility at ESCMID-Global 2024.
China's National Medical Products Administration approved an intravenous β-lactam/β-lactamase inhibitor combination for HABP/VABP caused by susceptible Acinetobacter isolates.
Appointment of a Chief Commercial Officer to lead commercial strategy and portfolio growth.
Results from the pivotal Phase 3 ATTACK trial comparing a β-lactam/β-lactamase inhibitor combination versus colistin for serious infections due to Acinetobacter were published.
U.S. FDA approved an intravenous β-lactam/β-lactamase inhibitor co-pack for treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter isolates; product became available in the U.S.
A global Phase 3 trial of an investigational single-dose oral antibiotic demonstrated non-inferiority to a standard-of-care injectable/combination regimen and met its primary endpoint; data were announced in a press release and presented at scientific meetings.
Presentation of the pivotal Phase 3 oral antibiotic trial data and multiple posters covering safety, PK/DDI and antimicrobial susceptibility at ESCMID-Global 2024.
China's National Medical Products Administration approved an intravenous β-lactam/β-lactamase inhibitor combination for HABP/VABP caused by susceptible Acinetobacter isolates.
Appointment of a Chief Commercial Officer to lead commercial strategy and portfolio growth.