HHS
boosts stockpile of products to treat acute radiation syndrome
FOR
IMMEDIATE RELEASE
September
26, 2013 |
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.
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