Contracts allow repurposing of a commercial cancer therapy for use in emergencies
Orders placed today under Project BioShield contracts will increase the national stockpile of leukocyte growth factors, a treatment for acute radiation syndrome. The products ordered by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response could save lives of survivors exposed to high doses of radiation following a radiological or nuclear emergency.
Managed by ASPR’s Biomedical Advanced Research and Development Authority, Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats.
This is the first time under Project BioShield that commercially available products are being purchased to establish a sustainable emergency response capability.
“Today’s agreements are a prime example how Project BioShield can be leveraged to bring our nation the medical countermeasures we need to face threats from chemical, biological or radiological emergencies,” explained BARDA Director Robin Robinson, Ph.D.
Leukocyte growth factors, sometimes referred to as cytokines or colony-stimulating factors, stimulate bone marrow to produce infection-fighting white blood cells known as neutrophils. Leukocyte growth factors are approved by the U.S. Food and Drug Administration, and used for cancer patients undergoing chemotherapy to speed white blood cell recovery and reduce the risk of infection.
Acute radiation syndrome is a serious illness that occurs in people exposed to high doses of radiation. The condition involves injuries to the body’s organs, including the bone marrow, gastrointestinal tract, and lungs, and can cause neutropenia, an abnormally low level of neutrophils.
No drugs or products are approved by FDA to treat the effects of Acute Radiation Syndrome, but leukocyte growth factors potentially could be used after a radiological or nuclear attack with emergency use authorization from FDA.
HHS awarded a $36.5 million contract to sanofi-aventis of Bridgewater, N.J., for late stage development and procurement of a leukocyte growth factor called Leukine, and a 157.5 million contract to Amgen USA Inc. of Thousand Oaks, Calif., to purchase the leukocyte growth factor called Neupogen.
The leukocyte growth factors acquired under this contract will remain in the possession of the manufacturers in vendor-managed inventory until they are needed. The companies will rotate this inventory to meet commercial demand so that the inventory does not expire.
Under the Project BioShield Act of 2004, BARDA has supported the development and procurement of 12 medical countermeasures, including those needed to treat some of the health impacts of ionizing radiation, as well as drugs or products to treat illness from anthrax, smallpox, and botulism.
This work is part of BARDA’s comprehensive, integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to radiological and nuclear agents, these threats include chemical and biological terrorism threats, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. For information about medical countermeasures, go to www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.