HHS Invests $45.3M for Organophosphate Poisoning Treatment Development
Contract Overview
Contract Amount: $45,323,792 ($45.3M)
Contractor: Aktivax, Inc.
Awarding Agency: Department of Health and Human Services
Start Date: 2022-09-30
End Date: 2026-12-31
Contract Duration: 1,553 days
Daily Burn Rate: $29.2K/day
Competition Type: FULL AND OPEN COMPETITION
Number of Offers Received: 2
Pricing Type: COST NO FEE
Sector: R&D
Official Description: THIS ACQUISITION WILL ALLOW BARDA TO INVEST PROJECT BIOSHIELD FUNDS FOR LATE-STAGE CLINICAL DEVELOPMENT, REGULATORY APPROVAL FOR 2-PAM AUTOINJECTORS (AS A DRUG/DEVICE COMBINATION PRODUCT) TO TREAT ORGANOPHOSPHATE (OP) POISONING, INCLUDING NERVE AGENT
Place of Performance
Location: BROOMFIELD, BROOMFIELD County, COLORADO, 80021
State: Colorado Government Spending
Plain-Language Summary
Department of Health and Human Services obligated $45.3 million to AKTIVAX, INC. for work described as: THIS ACQUISITION WILL ALLOW BARDA TO INVEST PROJECT BIOSHIELD FUNDS FOR LATE-STAGE CLINICAL DEVELOPMENT, REGULATORY APPROVAL FOR 2-PAM AUTOINJECTORS (AS A DRUG/DEVICE COMBINATION PRODUCT) TO TREAT ORGANOPHOSPHATE (OP) POISONING, INCLUDING NERVE AGENT Key points: 1. Investment targets late-stage clinical development and regulatory approval for 2-PAM autoinjectors. 2. The acquisition aims to treat organophosphate poisoning, including nerve agent exposure. 3. Competition method is 'Full and Open', suggesting broad market engagement. 4. The sector is Research and Development in Biotechnology, indicating innovation focus.
Value Assessment
Rating: good
The contract value of $45.3M for late-stage R&D is within a reasonable range for drug/device combination product development. Benchmarking against similar Project BioShield investments would provide further context.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The 'Full and Open Competition' method allows any qualified vendor to bid, promoting price discovery and potentially better value. The definitive contract award indicates a structured procurement process.
Taxpayer Impact: Taxpayer funds are being used to develop a critical medical countermeasure, potentially saving lives and reducing long-term healthcare costs associated with severe poisoning.
Public Impact
Enhances national preparedness against chemical threats like nerve agents. Supports the development of a vital medical countermeasure for public health emergencies. Potential to improve survival rates and reduce severity of organophosphate poisoning.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Potential for development delays in complex drug/device combination products.
- Reliance on a single awardee for a critical countermeasure.
Positive Signals
- Addresses a significant public health threat.
- Utilizes Project BioShield funds for advanced development.
- Full and open competition may drive innovation and value.
Sector Analysis
This contract falls within the Biotechnology R&D sector, focusing on medical countermeasures. Spending in this area is crucial for national security and public health preparedness, often involving significant investment for advanced development stages.
Small Business Impact
The data indicates this is a definitive contract awarded to AKTIVAX, INC. There is no explicit mention of small business participation or subcontracting goals in the provided data.
Oversight & Accountability
The Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS is responsible for overseeing such acquisitions. Oversight would focus on milestone achievement, adherence to regulatory pathways, and responsible use of funds.
Related Government Programs
- Research and Development in Biotechnology (except Nanobiotechnology)
- Department of Health and Human Services Contracting
- Office of Assistant Secretary for Preparedness and Response Programs
Risk Flags
- Development timeline risk
- Regulatory approval risk
- Clinical trial success risk
- Market adoption risk
Tags
research-and-development-in-biotechnolog, department-of-health-and-human-services, co, definitive-contract, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $45.3 million to AKTIVAX, INC.. THIS ACQUISITION WILL ALLOW BARDA TO INVEST PROJECT BIOSHIELD FUNDS FOR LATE-STAGE CLINICAL DEVELOPMENT, REGULATORY APPROVAL FOR 2-PAM AUTOINJECTORS (AS A DRUG/DEVICE COMBINATION PRODUCT) TO TREAT ORGANOPHOSPHATE (OP) POISONING, INCLUDING NERVE AGENT
Who is the contractor on this award?
The obligated recipient is AKTIVAX, INC..
Which agency awarded this contract?
Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).
What is the total obligated amount?
The obligated amount is $45.3 million.
What is the period of performance?
Start: 2022-09-30. End: 2026-12-31.
What is the projected timeline for regulatory approval and market availability of the 2-PAM autoinjectors?
The contract end date is December 31, 2026, suggesting that regulatory approval and market availability are anticipated within this timeframe. However, the complexity of drug/device combination products and clinical trial outcomes can influence this timeline, potentially leading to extensions or delays.
What are the specific performance metrics and milestones tied to the $45.3M contract to ensure accountability?
While specific performance metrics are not detailed here, definitive contracts typically include phased milestones tied to funding tranches. These usually involve successful completion of preclinical studies, specific phases of clinical trials (Phase I, II, III), and submission of regulatory dossiers to the FDA.
How does the cost compare to similar investments in developing medical countermeasures for chemical threats?
Benchmarking this $45.3M investment against similar Project BioShield or BARDA-funded initiatives for late-stage development of drug/device combination products would be necessary for a precise comparison. The cost appears reasonable given the high-risk, high-reward nature of developing novel medical countermeasures.
Industry Classification
NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)
Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services
Competition & Pricing
Extent Competed: FULL AND OPEN COMPETITION
Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE
Solicitation ID: 75A50122R00022
Offers Received: 2
Pricing Type: COST NO FEE (S)
Evaluated Preference: NONE
Contractor Details
Address: 100 TECHNOLOGY DR, BROOMFIELD, CO, 80021
Business Categories: Category Business, Corporate Entity Not Tax Exempt, Manufacturer of Goods, Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $220,246,768
Exercised Options: $45,323,792
Current Obligation: $45,323,792
Actual Outlays: $10,036,713
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Timeline
Start Date: 2022-09-30
Current End Date: 2026-12-31
Potential End Date: 2039-12-31 00:00:00
Last Modified: 2024-09-11
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