HHS awards $26.4M contract to Amgen Inc. for Romiplostim development to treat radiation and chemotherapy-induced conditions

Contract Overview

Contract Amount: $26,408,674 ($26.4M)

Contractor: Amgen Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2019-09-26

End Date: 2027-12-31

Contract Duration: 3,018 days

Daily Burn Rate: $8.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: R&D

Official Description: THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF ROMIPLOSTIM FOR TREATMENT OF HEMATOPOIETIC SUBSYNDROME-ACUTE RADIATION SYNDROME (HS-ARS) AND CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA (CIT) AND A DRUG DELIVERY DEVICE FEASIBILITY PROJECT WITH AN OPTION TO

Place of Performance

Location: NEWBURY PARK, VENTURA County, CALIFORNIA, 91320

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $26.4 million to AMGEN INC. for work described as: THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF ROMIPLOSTIM FOR TREATMENT OF HEMATOPOIETIC SUBSYNDROME-ACUTE RADIATION SYNDROME (HS-ARS) AND CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA (CIT) AND A DRUG DELIVERY DEVICE FEASIBILITY PROJECT WITH AN OPTION TO Key points: 1. Contract focuses on advancing a novel therapeutic for critical health conditions, indicating a strategic investment in biodefense and medical countermeasures. 2. The award to a major biopharmaceutical company suggests a reliance on established industry players for complex drug development. 3. Long-term contract duration (over 8 years) implies a phased development approach with potential for follow-on funding. 4. The 'Research and Development in Biotechnology' classification highlights the cutting-edge nature of the work. 5. The contract's value, while substantial, should be benchmarked against similar advanced therapeutic development programs. 6. The absence of small business set-asides suggests the scope of work requires specialized capabilities typically found in larger firms.

Value Assessment

Rating: good

The contract value of $26.4 million over approximately 8 years for advanced drug development appears reasonable, especially considering the specialized nature of biotechnology research and development. Benchmarking against similar contracts for novel therapeutic development, particularly those targeting rare or severe conditions like radiation syndrome, would provide a more precise assessment of value. The 'Cost No Fee' contract type suggests that the government will reimburse Amgen for allowable costs incurred, which is common in R&D where final costs can be uncertain. However, without detailed cost breakdowns, a definitive value-for-money assessment is challenging.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. While the specific number of bidders is not provided, this competitive process is generally expected to yield fair pricing and innovative solutions. The fact that a large, established firm like Amgen Inc. was selected suggests they offered the most advantageous proposal based on technical merit, past performance, and price.

Taxpayer Impact: Full and open competition is beneficial for taxpayers as it fosters a competitive environment, driving down costs and encouraging the best possible solutions to be brought forward.

Public Impact

The primary beneficiaries are individuals at risk of or suffering from Hematopoietic Subsyndrome-Acute Radiation Syndrome (HS-ARS) and Chemotherapy-Induced Thrombocytopenia (CIT). The contract aims to deliver a novel drug (Romiplostim) and a drug delivery device, enhancing treatment options for severe medical conditions. Geographic impact is likely national, focusing on preparedness for potential radiation events and supporting cancer treatment infrastructure. Workforce implications include specialized roles in biotechnology research, clinical trials, and pharmaceutical manufacturing.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in long-term R&D projects.
Dependence on a single contractor for critical drug development.
Uncertainty in achieving desired therapeutic outcomes within the projected timeline and budget.

Positive Signals

Award to a reputable company with a track record in drug development.
Focus on a critical unmet medical need with significant public health implications.
Competitive award process suggests a thorough evaluation of proposals.

Sector Analysis

This contract falls within the Biotechnology R&D sector, a rapidly evolving field focused on developing novel therapies and medical technologies. The market for treatments for radiation exposure and chemotherapy side effects is significant, driven by national security concerns (biodefense) and the widespread use of chemotherapy. Comparable spending benchmarks would involve looking at other government contracts for advanced therapeutic development, particularly those funded by agencies like BARDA (Biomedical Advanced Research and Development Authority) or NIH (National Institutes of Health), which often involve substantial investments in early-stage and late-stage drug development.

Small Business Impact

The contract was not awarded as a small business set-aside, and the prime contractor, Amgen Inc., is a large pharmaceutical company. This suggests that the specialized nature and scale of the research and development required for Romiplostim are beyond the typical capabilities or capacity of small businesses in this specific R&D area. There is no explicit information provided regarding subcontracting plans for small businesses, which could be a missed opportunity to engage smaller, innovative firms in specific aspects of the project.

Oversight & Accountability

Oversight for this contract is likely managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures would include regular progress reports, milestone reviews, and financial audits to ensure adherence to the contract terms and efficient use of funds. Transparency is facilitated through contract award databases and public reporting requirements. Inspector General jurisdiction would apply to any potential fraud, waste, or abuse related to the contract.

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) programs
National Institutes of Health (NIH) research grants
Department of Defense medical countermeasure development
Advanced Pharmaceutical Development Contracts

Risk Flags

Long-term R&D contract duration
Potential for scope creep or evolving requirements
Reliance on a single source for critical technology development

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $26.4 million to AMGEN INC.. THIS CONTRACT IS TO ADVANCE THE DEVELOPMENT OF ROMIPLOSTIM FOR TREATMENT OF HEMATOPOIETIC SUBSYNDROME-ACUTE RADIATION SYNDROME (HS-ARS) AND CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA (CIT) AND A DRUG DELIVERY DEVICE FEASIBILITY PROJECT WITH AN OPTION TO

Who is the contractor on this award?

The obligated recipient is AMGEN 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 $26.4 million.

What is the period of performance?

Start: 2019-09-26. End: 2027-12-31.

What is Amgen Inc.'s track record with government contracts, particularly in R&D for biodefense or similar therapeutic areas?

Amgen Inc. is a well-established biotechnology company with a significant track record in drug discovery, development, and commercialization. While specific details of their government contract history are not provided in this data snippet, their extensive experience in developing complex biologics, including treatments for conditions related to blood disorders (like anemia, which Romiplostim addresses), suggests a strong capability relevant to this contract. Government agencies often contract with large, experienced firms like Amgen for high-risk, high-reward R&D projects due to their established infrastructure, scientific expertise, and regulatory navigation capabilities. Past performance on similar government contracts, if available through federal procurement databases, would offer further insight into their reliability and success rates in meeting government objectives.

How does the $26.4 million contract value compare to similar government investments in advanced therapeutic development for radiation countermeasures or chemotherapy-induced conditions?

The $26.4 million contract value over approximately 8 years for the development of Romiplostim and a drug delivery device is substantial but falls within the typical range for advanced pharmaceutical R&D funded by the government. Agencies like BARDA and NIH frequently award contracts in the tens to hundreds of millions of dollars for the development of novel medical countermeasures, vaccines, and therapeutics. For instance, contracts for developing treatments for emerging infectious diseases or biothreat agents often involve significant investment over extended periods to navigate the complex preclinical and clinical trial phases. The value here appears commensurate with the high-risk, long-term nature of developing a new drug for a critical, albeit niche, indication like HS-ARS and CIT, especially when considering the rigorous regulatory pathway and the need for specialized manufacturing capabilities.

What are the primary risks associated with this contract, and what mitigation strategies are likely in place?

The primary risks associated with this contract are inherent to advanced R&D: scientific risk (the drug may not prove effective or safe), regulatory risk (failure to gain FDA approval), manufacturing risk (challenges in scaling up production), and schedule/cost risk (delays and cost overruns). Mitigation strategies likely include phased development with clear go/no-go decision points, robust scientific and clinical trial design, close collaboration between Amgen and HHS/ASPR, and potentially performance incentives or penalties tied to milestones. The 'Cost No Fee' contract type, while reimbursing costs, also implies close financial oversight. Amgen's established expertise in drug development also serves as a risk mitigation factor, as they possess the experience to anticipate and address many of these challenges.

What is the expected program effectiveness and impact on public health preparedness?

The expected program effectiveness hinges on the successful development and FDA approval of Romiplostim for HS-ARS and CIT. If successful, this drug could significantly improve patient outcomes by mitigating the severe consequences of radiation exposure and chemotherapy, thereby enhancing the nation's preparedness for radiological events and improving cancer care. HS-ARS can be life-threatening, and effective treatments are crucial for emergency response. Similarly, CIT can lead to serious bleeding complications, impacting cancer treatment regimens. The development of a reliable drug delivery device further enhances the potential effectiveness and usability of the therapeutic. The ultimate impact on public health preparedness would be a strengthened medical countermeasure capability against radiation threats and improved supportive care for cancer patients.

How has federal spending in biotechnology R&D, specifically for biodefense or radiation countermeasures, trended in recent years?

Federal spending in biotechnology R&D, particularly for biodefense and radiation countermeasures, has seen a notable increase in recent years, driven by evolving national security threats and a greater emphasis on pandemic preparedness. Agencies like HHS (through ASPR and BARDA), DOD, and NIH consistently allocate significant funding to this sector. This trend reflects a strategic effort to bolster domestic capabilities in developing vaccines, therapeutics, and diagnostics against a range of threats, from naturally occurring outbreaks to deliberate biological attacks. Investments often focus on platform technologies and broad-spectrum countermeasures that can be rapidly adapted. The sustained funding reflects a long-term commitment to addressing these critical public health and security challenges, making contracts like this one part of a larger, ongoing federal strategy.

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: BAA18100SOL00003

Offers Received: 1

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 1 AMGEN CENTER DR, THOUSAND OAKS, CA, 91320

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

Financial Breakdown

Contract Ceiling: $33,719,968

Exercised Options: $26,408,674

Current Obligation: $26,408,674

Actual Outlays: $18,337,657

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline