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BAXTER STUDY VERIFIES VIRAL INACTIVATION OF WEST NILE VIRUS FROM ITS PLASMA-DERIVED
THERAPIES
Exclusive Data
Presented at FDA Public Forum
Deerfield, Ill, November
5, 2002 - Baxter Healthcare Corporation today presented the first data
that verifies the inactivation of West Nile Virus (WNV) during the processes
routinely used in the production of its plasma-derived therapeutics.
Baxter initiated the
verification study to address the rising public concern over the perceived
threat of transmission of WNV through use of plasma-derivatives. The study
follows recent reports about increased incidence of WNV in the United
States and the transmission of WNV through organ donations and blood transfusions.
These data were presented
at a two-day public workshop hosted by the U.S. Food and Drug Administration
Center for Biologics Evaluation and Research in cooperation with the Centers
for Disease Control and Prevention (CDC), the National Heart, Lung and
Blood Institute, National Institutes of Health and the Health Resources
Services Administration.
Study Shows WNV
Readily Inactivated
WNV is a member of the Flaviviridae family of viruses and its structure
is similar to previously identified viruses such as Hepatitis C. This
family of enveloped viruses can be readily inactivated through proven
inactivation processes such as pasteurization, vapor heating and solvent
detergent treatment.
"Based on available
results from structurally-related viruses, we were sure that WNV would
be inactivated during the processing of our plasma-derived therapeutics,"
said Thomas R. Kreil, Ph.D., director, global pathogen safety. "However,
we at Baxter acknowledge that the hemophilia community is especially concerned
about this specific virus, and we decided to conduct these tests to reassure
people who use plasma-derived therapies from Baxter."
This study, using
an infectivity assay with a 1999 New York isolate of the virus, confirmed
that WNV was readily inactivated through pasteurization, vapor heating
and solvent detergent treatment methods that Baxter employs in the processing
of its commercially available plasma derivatives.
About West Nile
Virus
WNV, known by the medical community in other parts of the world for more
than fifty years, first captured national attention in 1999 when an outbreak
in Queens, NY, occurred. This virus has since spread across the U.S. and
confirmed cases have been reported in 39 states, according to the CDC.
Most people who contract
the virus have no symptoms, while 20 percent develop minor symptoms, and
in rare cases the virus results in severe symptoms and even death. CDC
statistics show that as of October 30, 2002, there have been 3,419 confirmed
cases of WNV in the U.S., and 196 confirmed deaths.
About Baxter
Baxter Healthcare Corporation is the principal domestic operating business
of Baxter International Inc. (NYSE: BAX). Baxter International Inc. is
a global health care company that, through its subsidiaries, provides
critical therapies for people with life-threatening conditions. Baxter's
bioscience, medication delivery and renal products and services are used
to treat patients with some of the most challenging medical conditions
including hemophilia, immune deficiencies, infectious diseases, trauma,
cancer and kidney disease.
FOR ADDITIONAL
INFORMATION:
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Media Contacts:
- Deborah
Spak, 847-948-2349
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