[Ip-health] More on government support for development of Siga's ST-246

Jamie Love james.love at keionline.org
Sun Nov 13 08:53:38 PST 2011


These backgrounder documents on the Siga website provide more context
on the David Willman story in the LA Times about Siga's no-bid
contract on the smallpox drug.  The Obama Administration has pretty
much ignored the role of federal support for the R&D in setting the
price.   Jamie


http://www.siga.com/index.php?ID=12

Government Relations

SIGA has found that working relationships with federal partners and
academic laboratories are essential to its success. Category A
pathogens must be tested in facilities with the highest level of
biosecurity and safety, and few U.S. centers are equipped for BSL-3 or
-4 work. SIGA collaborates with numerous federal and academic BSL-3
and -4 installations to perform the necessary tests on its drug
candidates.  As a result, SIGA has solid, longstanding relationships
with many federal agencies and an enviable track record of obtaining
federal funding to support its research and development activities.

Moreover, the federal government shifted its budget priorities to
emphasize potential terrorist threats and their countermeasures after
the 9/11 attack.  Funding for research and development of agents
against biological threats has risen dramatically since then, and is
expected to grow even further.  The “Implementation Plan” for
biowarfare threats, released by the U.S. Department of Health and
Human Services Public Health Emergency Medical Countermeasure
Enterprise in April 2007, specifically identified the need for
countermeasures against smallpox and the hemorrhagic fever viruses
(Ebola and Junín).  In response to this demand, SIGA is currently
working to supply essential countermeasures to the Strategic National
Stockpile and the Department of Defense.

SIGA’s government partners

http://www.siga.com/?ID=14

Agencies and Activities

* National Institute of Allergy and Infectious Diseases (NIAID) –
NIAID has been a major supporter of SIGA antiviral countermeasure
development, awarding approximately $47 million in funding since 2006.

* Office of Biodefense Research Affairs (OBRA) – In addition to
administering the major contract supporting ST-246® (Tecovirimat)
development, OBRA has provided access to animal models and preclinical
testing capabilities.

* Department of Defense (DOD) – Several federal appropriations
administered by the U.S. Army, the U.S. Air Force and the Defense
Threat Reduction Agency have supported SIGA’s programs.
The Defense Threat Reduction Agency (DTRA) – DTRA has provided
essential funding to enable the testing of ST-246 in monkeypox and
smallpox infected non-human primates under BSL-3 and BSL-4 conditions,
respectively as well as provided support for our broad-spectrum
antiviral.

* The United States Army Medical Research Institute for Infectious
Diseases (USAMRIID) – SIGA has numerous ongoing projects with
scientists at USAMRIID to test viral countermeasures against
monkeypox, smallpox, Ebola and Lassa fever.

* Defense Science and Technology Laboratories (DSTL) – At Porton Down
in the U.K., SIGA is working with DSTL scientists to test the
effectiveness of ST-246 in murine aerosol challenge models.

* Centers for Disease Control and Prevention (CDC) - All of the in
vitro and in vivo testing of ST-246 against variola virus has been
conducted at the CDC BSL-4 laboratories in Atlanta.  In addition,
SIGA worked closely with CDC scientists on the treatment of several
emergency cases that were conducted under eINDs, which are emergency
Investigational New Drug applications.

* Biomedical Advanced Research and Development Authority (BARDA) –
Like NIAID, BARDA has also been a major supporter of ST-246 over the
last few years.  BARDA is responsible for acquiring vaccines and drugs
for Project BioShield as well as countermeasures for emerging
infectious diseases and supplying them to the Strategic National
Stockpile (SNS).

--
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
using my MaxRoam number: +447937390810
twitter.com/jamie_love




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