SIGA Pharmaceuticals, Inc
SIGA is a leader in global health, developing medicines to prevent and treat emerging infectious diseases with high unmet medical needs. They focus on orthopoxviruses such as smallpox and mpox, and collaborate with governments, organizations, and partners worldwide to enhance global health security. Their mission is to proactively prevent and stop outbreaks, whether natural, accidental, or intentional.
Industries
Nr. of Employees
small (1-50)
Products
Tecovirimat (small-molecule antiviral for orthopoxviruses)
A targeted small-molecule antiviral that inhibits a viral surface protein involved in virion egress to limit spread of orthopoxvirus infections; formulated as oral capsules and an intravenous formulation, with a pediatric liquid suspension under development.
Tecovirimat (small-molecule antiviral for orthopoxviruses)
A targeted small-molecule antiviral that inhibits a viral surface protein involved in virion egress to limit spread of orthopoxvirus infections; formulated as oral capsules and an intravenous formulation, with a pediatric liquid suspension under development.
Services
Contract manufacturing network and supply chain management
Set up and management of external manufacturing partners and supply chain to ensure quality production of commercial pharmaceutical products.
Regulatory strategy and submission support for biodefense therapeutics
Design and execution of regulatory pathways for products where conventional human efficacy trials are not feasible, including coordination with regulatory agencies and use of expedited designations.
Clinical development and expanded access program management
Design and management of clinical safety studies in volunteers, expanded access protocols, and indication-specific clinical programs such as post-exposure prophylaxis and pediatric studies.
Government partnership and stockpile procurement support
Engagement and contracting with government agencies for advanced development funding, procurement, and placement of medical countermeasures into national stockpiles.
Contract manufacturing network and supply chain management
Set up and management of external manufacturing partners and supply chain to ensure quality production of commercial pharmaceutical products.
Regulatory strategy and submission support for biodefense therapeutics
Design and execution of regulatory pathways for products where conventional human efficacy trials are not feasible, including coordination with regulatory agencies and use of expedited designations.
Clinical development and expanded access program management
Design and management of clinical safety studies in volunteers, expanded access protocols, and indication-specific clinical programs such as post-exposure prophylaxis and pediatric studies.
Government partnership and stockpile procurement support
Engagement and contracting with government agencies for advanced development funding, procurement, and placement of medical countermeasures into national stockpiles.
Expertise Areas
- Antiviral drug discovery and development
- Regulatory strategy for biodefense countermeasures
- Clinical development under the FDA Animal Rule and expanded access protocols
- CMC and formulation development for oral, IV, and pediatric dosage forms
Key Technologies
- Small-molecule antiviral development
- Viral egress (VP37) targeted mechanism
- Animal-model efficacy testing
- FDA Animal Rule regulatory pathway