HHS awards $18.8M contract to Synedgen for GI-AR drug development

Contract Overview

Contract Amount: $18,828,663 ($18.8M)

Contractor: Synedgen, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-30

End Date: 2026-09-30

Contract Duration: 730 days

Daily Burn Rate: $25.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ADVANCE THE DEVELOPMENT OF PAAG17G (DRUG PRODUCT: MIIST305), A ONCE DAILY, ORALLY ADMINISTERED, GUT-RESTRICTED DRUG, TO REDUCE MORTALITY AND MORBIDITY ARISING FROM ACUTE EXPOSURE TO IONIZING RADIATION, SPECIFICALLY GASTROINTESTINAL (GI) INJURY (GI-AR

Place of Performance

Location: CLAREMONT, LOS ANGELES County, CALIFORNIA, 91711

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $18.8 million to SYNEDGEN, INC. for work described as: ADVANCE THE DEVELOPMENT OF PAAG17G (DRUG PRODUCT: MIIST305), A ONCE DAILY, ORALLY ADMINISTERED, GUT-RESTRICTED DRUG, TO REDUCE MORTALITY AND MORBIDITY ARISING FROM ACUTE EXPOSURE TO IONIZING RADIATION, SPECIFICALLY GASTROINTESTINAL (GI) INJURY (GI-AR Key points: 1. Contract focuses on developing a novel oral drug to mitigate radiation-induced gastrointestinal injury. 2. Synedgen, Inc. is the sole awardee under full and open competition. 3. The contract aims to reduce mortality and morbidity from acute radiation exposure. 4. Research and Development in Physical, Engineering, and Life Sciences is the relevant sector.

Value Assessment

Rating: good

The contract value of $18.8M for a 2-year R&D effort appears reasonable given the specialized nature of drug development for radiation countermeasures. Benchmarking against similar early-stage pharmaceutical development contracts would provide further context.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and innovation.

Taxpayer Impact: Investment in radiation countermeasures is crucial for national security and public health preparedness, potentially saving lives and reducing long-term healthcare costs in the event of a radiological incident.

Public Impact

Enhances national preparedness for radiological emergencies. Supports development of critical medical countermeasures. Potential to save lives and reduce healthcare burden after radiation exposure. Advances pharmaceutical research in a specialized field.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in R&D projects.
Long development timelines for pharmaceuticals.
Uncertainty of drug efficacy and market adoption.

Positive Signals

Addresses a critical unmet medical need.
Sole awardee under full and open competition.
Clear objective to reduce mortality and morbidity.

Sector Analysis

This contract falls within the Research and Development in the Physical, Engineering, and Life Sciences sector, specifically focusing on pharmaceutical development for medical countermeasures. Spending in this area is often driven by national security and public health initiatives.

Small Business Impact

The data indicates this contract was awarded to Synedgen, Inc. There is no specific information provided regarding small business participation or subcontracting goals for this particular award.

Oversight & Accountability

The Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS is responsible for this contract, indicating oversight by a dedicated agency focused on public health emergencies. Standard contract oversight mechanisms would apply.

Related Government Programs

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Potential for R&D cost overruns.
Uncertainty of drug efficacy and regulatory approval.
Long development cycle for pharmaceuticals.
Dependence on a single contractor for this specific countermeasure.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $18.8 million to SYNEDGEN, INC.. ADVANCE THE DEVELOPMENT OF PAAG17G (DRUG PRODUCT: MIIST305), A ONCE DAILY, ORALLY ADMINISTERED, GUT-RESTRICTED DRUG, TO REDUCE MORTALITY AND MORBIDITY ARISING FROM ACUTE EXPOSURE TO IONIZING RADIATION, SPECIFICALLY GASTROINTESTINAL (GI) INJURY (GI-AR

Who is the contractor on this award?

The obligated recipient is SYNEDGEN, 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 $18.8 million.

What is the period of performance?

Start: 2024-09-30. End: 2026-09-30.

What is the projected timeline for achieving key development milestones for the PAAG17G drug product?

The contract duration is 730 days, ending September 30, 2026. While specific milestone timelines are not detailed in this award notice, the contract period suggests an expectation of significant progress towards drug development within this timeframe. Further details on interim deliverables and review points would be found in the contract's statement of work.

How does the cost-plus-fixed-fee structure mitigate risks associated with novel drug development?

A Cost-Plus-Fixed-Fee (CPFF) contract allows the government to reimburse the contractor for allowable costs incurred, plus a predetermined fixed fee. This structure is often used for R&D where the final costs are uncertain. It incentivizes the contractor to control costs while ensuring the project can proceed, balancing risk between the government and the contractor.

What are the potential long-term implications if this drug development is successful?

Successful development of PAAG17G could significantly enhance national biodefense capabilities by providing a critical medical countermeasure against radiation-induced gastrointestinal injury. This would improve survivability and reduce long-term health consequences for individuals exposed to ionizing radiation, bolstering public health resilience and national security.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

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: BAA-23-100-SOL-00004

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 1420 N CLAREMONT BLVD, CLAREMONT, CA, 91711

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $121,533,645

Exercised Options: $18,828,663

Current Obligation: $18,828,663

Actual Outlays: $9,327,564

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline