Innoviva Specialty Therapeutics
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
medium (51-250)
Innoviva Specialty Therapeutics
Waltham, Massachusetts, United States, North America
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
Medical affairs and scientific communications
Preparation and dissemination of peer-reviewed publications, conference presentations, educational resources for healthcare professionals, and medical information contact services.
Clinical development and trial operations
End-to-end clinical program support including protocol design, global site management, patient recruitment and statistical analysis for registrational programs.
Commercialization and portfolio management
Commercial planning, launch execution and specialty distribution for critical-care and infectious disease product portfolios, including market access and sales operations.
Medical affairs and scientific communications
Preparation and dissemination of peer-reviewed publications, conference presentations, educational resources for healthcare professionals, and medical information contact services.
Clinical development and trial operations
End-to-end clinical program support including protocol design, global site management, patient recruitment and statistical analysis for registrational programs.
Commercialization and portfolio management
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