HHS awards $11.4M contract for respiratory stimulant, a medical countermeasure for respiratory depression

Contract Overview

Contract Amount: $11,399,146 ($11.4M)

Contractor: Enalare Therapeutics Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-22

End Date: 2026-09-30

Contract Duration: 1,469 days

Daily Burn Rate: $7.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ENALARE THERAPEUTICS: AN AGNOSTIC RESPIRATORY STIMULANT FOR USE AS A MEDICAL COUNTERMEASURE TO TREAT RESPIRATORY DEPRESSION

Place of Performance

Location: PRINCETON, MERCER County, NEW JERSEY, 08540

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $11.4 million to ENALARE THERAPEUTICS INC for work described as: ENALARE THERAPEUTICS: AN AGNOSTIC RESPIRATORY STIMULANT FOR USE AS A MEDICAL COUNTERMEASURE TO TREAT RESPIRATORY DEPRESSION Key points: 1. Contract focuses on research and development in biotechnology, specifically for a novel respiratory stimulant. 2. The award is a definitive contract with a cost-plus-fixed-fee payment structure. 3. The contract duration extends over 1469 days, indicating a long-term research and development effort. 4. The primary objective is to develop a medical countermeasure against respiratory depression. 5. The contract was awarded through full and open competition, suggesting a robust bidding process. 6. The contractor, Enalare Therapeutics Inc., is based in New Jersey.

Value Assessment

Rating: fair

The contract value of $11.4 million for research and development in biotechnology is within a typical range for early-stage medical countermeasure development. However, without specific benchmarks for this particular type of stimulant or comparable contracts for similar countermeasures, a precise value-for-money assessment is challenging. The cost-plus-fixed-fee structure allows for flexibility in research but can sometimes lead to higher costs if not closely managed. Further analysis would require understanding the developmental milestones and the fixed fee's reasonableness.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors were likely solicited and had the opportunity to bid. This suggests a competitive environment where the government sought the best technical approach and price. The number of bidders is not specified, but the designation implies a broad solicitation process, which generally promotes price discovery and innovation.

Taxpayer Impact: Full and open competition is generally favorable for taxpayers as it increases the likelihood of obtaining competitive pricing and encourages a wider range of solutions, potentially leading to better value.

Public Impact

The primary beneficiaries are the public, who will gain access to a potential medical countermeasure for respiratory depression. The service delivered is research and development aimed at creating a novel therapeutic. The geographic impact is primarily within New Jersey, where the contractor is located, but the ultimate benefit is national. Workforce implications include potential job creation in the biotechnology sector within New Jersey.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The long contract duration (1469 days) could present risks if research milestones are not met or if the technology proves unviable.
Cost-plus-fixed-fee contracts require diligent oversight to ensure costs remain reasonable and the fixed fee is justified.
The specific nature of a novel stimulant requires rigorous testing and validation, which carries inherent scientific risk.

Positive Signals

The contract is for a critical medical countermeasure, addressing a significant public health need.
Awarding through full and open competition suggests a thorough vetting process and potential for competitive pricing.
The focus on R&D in biotechnology aligns with national priorities for preparedness against health threats.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a rapidly growing area focused on developing novel therapeutics and medical countermeasures. The market for such countermeasures is driven by national security and public health preparedness needs. Comparable spending benchmarks would typically involve other government-funded R&D contracts for pharmaceuticals or medical devices aimed at specific threats, often awarded by agencies like BARDA within HHS or DoD.

Small Business Impact

The contract does not indicate any specific small business set-aside. As a definitive contract awarded through full and open competition, it is unlikely to have direct subcontracting requirements specifically for small businesses unless mandated by the prime contractor's own business practices. The impact on the small business ecosystem is therefore minimal for this specific award, though the success of Enalare Therapeutics could foster future opportunities.

Oversight & Accountability

Oversight for this contract would primarily fall under the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). Accountability measures will be tied to the achievement of research and development milestones outlined in the contract. Transparency is facilitated through contract award databases, though detailed research progress reports are typically proprietary. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) programs
National Institutes of Health (NIH) research grants
Department of Defense (DoD) medical countermeasure development

Risk Flags

Long-term R&D project with inherent scientific uncertainty.
Cost-plus-fixed-fee contract requires diligent oversight of expenditures.
Potential for off-target effects or safety concerns with an 'agnostic' stimulant.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.4 million to ENALARE THERAPEUTICS INC. ENALARE THERAPEUTICS: AN AGNOSTIC RESPIRATORY STIMULANT FOR USE AS A MEDICAL COUNTERMEASURE TO TREAT RESPIRATORY DEPRESSION

Who is the contractor on this award?

The obligated recipient is ENALARE THERAPEUTICS 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 $11.4 million.

What is the period of performance?

Start: 2022-09-22. End: 2026-09-30.

What is the specific scientific basis for Enalare Therapeutics' proposed respiratory stimulant, and what is its potential efficacy compared to existing treatments or countermeasures?

The provided data does not detail the specific scientific basis or proposed mechanism of action for Enalare Therapeutics' respiratory stimulant. The contract description refers to it as an 'agnostic respiratory stimulant for use as a medical countermeasure to treat respiratory depression.' This suggests a broad applicability, potentially targeting common pathways involved in respiratory depression, regardless of the underlying cause (e.g., opioid overdose, anesthesia side effects, certain toxins). Efficacy comparison would require access to preclinical and clinical data, which is not publicly available at the time of this award. Typically, such countermeasures aim to provide rapid and effective reversal of respiratory depression with a favorable safety profile, ideally with fewer side effects than existing options like naloxone (for opioids) or flumazenil (for benzodiazepines).

How does the $11.4 million contract value compare to typical R&D investments for similar medical countermeasures?

The $11.4 million contract value for research and development of a medical countermeasure is within a reasonable range for early to mid-stage development. Developing novel therapeutics, especially those intended for emergency use or as countermeasures, involves significant investment in preclinical studies (pharmacology, toxicology), formulation, manufacturing process development, and potentially early-phase clinical trials. Government contracts for such work can range from a few million dollars for initial feasibility studies to tens or hundreds of millions for later-stage development and manufacturing scale-up. Without knowing the specific stage of development Enalare Therapeutics is in, it's difficult to provide a precise benchmark, but this award appears to cover critical research phases.

What are the key performance indicators (KPIs) or milestones associated with this Cost Plus Fixed Fee (CPFF) contract?

While the specific Key Performance Indicators (KPIs) and milestones are not detailed in the provided summary, a Cost Plus Fixed Fee (CPFF) contract for Research and Development (R&D) typically ties payments to the achievement of predefined technical and programmatic milestones. For a respiratory stimulant, these could include: successful completion of specific preclinical toxicology studies demonstrating safety and efficacy; development of a stable formulation; establishment of a scalable manufacturing process; achievement of specific pharmacokinetic/pharmacodynamic (PK/PD) profiles in animal models; and potentially, initiation or completion of Phase 1 human clinical trials. The 'fixed fee' component is negotiated upfront and represents the contractor's profit, which is earned upon successful completion of the contract's objectives, while the 'cost' portion covers allowable direct and indirect expenses incurred.

What is the track record of Enalare Therapeutics Inc. in developing and bringing medical countermeasures to market?

Information regarding Enalare Therapeutics Inc.'s specific track record in developing and bringing medical countermeasures to market is not readily available in the provided data. As a company likely focused on R&D, its history may involve prior research grants, smaller-scale development contracts, or proprietary research efforts. To assess their track record, one would typically look for previous FDA approvals, successful transitions of their products to larger pharmaceutical partners, or a history of delivering on government contracts related to medical countermeasures. Further investigation into the company's background, publications, patent filings, and previous government funding would be necessary for a comprehensive assessment.

What are the potential risks associated with developing an 'agnostic' respiratory stimulant, and how might they be mitigated?

Developing an 'agnostic' respiratory stimulant presents unique risks. 'Agnostic' implies broad applicability, which could mean targeting a fundamental physiological pathway. Risks include: 1) Off-target effects: Stimulating a fundamental pathway might lead to unintended physiological consequences in various organs or systems. 2) Efficacy limitations: While aiming for broad use, it might not be as effective as targeted therapies for specific causes of respiratory depression. 3) Safety profile: Achieving a universally safe profile across diverse patient populations and underlying conditions is challenging. Mitigation strategies involve rigorous preclinical testing across multiple models to identify potential toxicities and off-target effects, careful dose-ranging studies, and phased clinical trials designed to evaluate safety and efficacy in specific subpopulations before broader approval. The government contract likely mandates extensive safety and efficacy testing protocols.

How does this contract align with the strategic goals of the Office of Assistant Secretary for Preparedness and Response (ASPR)?

This contract directly aligns with the strategic goals of ASPR, which is responsible for leading the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies, including the use of chemical, biological, radiological, and nuclear (CBRN) threats. Developing medical countermeasures, such as a broad-acting respiratory stimulant, is a core component of ASPR's mission to ensure the availability of effective medical treatments during emergencies. Respiratory depression can be a consequence of exposure to certain toxins or chemical agents, or it can occur in mass casualty incidents. By funding the development of such a countermeasure, ASPR aims to enhance national preparedness and response capabilities, thereby protecting the public health and safety.

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: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 161 HODGE RD, PRINCETON, NJ, 08540

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

Financial Breakdown

Contract Ceiling: $55,766,220

Exercised Options: $11,399,146

Current Obligation: $11,399,146

Actual Outlays: $6,307,577

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline