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CERUS AND
BAXTER'S INTERCEPT DISPOSABLE SET FOR PLATELETS RECEIVES EUROPEAN REGULATORY
APPROVAL
Companies Poised
to Offer First Technology Available to Inactivate Pathogens in Platelets
Intended for Transfusion
CONCORD,
Calif. and DEERFIELD, Ill., June 4, 2002 -- Cerus Corporation (Nasdaq:
CERS) and subsidiaries of Baxter International Inc. (NYSE: BAX) today
announced receipt of CE Mark approval for the INTERCEPT Blood System disposable
set for inactivating pathogens in platelets prepared using the "buffy
coat" method, the predominant approach for preparing platelets used
for transfusion in Europe. As a result of this regulatory action, the
companies are positioned to be the first to offer a revolutionary approach
to inactivate a broad spectrum of pathogens that may be present in platelets,
targeting both potential emerging pathogens and known pathogens that may
escape detection by current testing systems.
The INTERCEPT Blood
System for platelets is a pathogen inactivation system consisting of a
disposable set containing a light-activated, nucleic acid-targeting compound
and an illumination device. CE Mark approval of the disposable set represents
the completion of regulatory review of the design dossier. The next step
is completion of the CE Mark process for the illumination device.
"The approval
of the disposable set for INTERCEPT Platelets is wonderful news, and sets
the stage for the first commercial application of our technology,"
said Stephen T. Isaacs, president and chief executive officer of Cerus.
"The final step prior to commercialization in Europe is to complete
the CE Marking process for the illumination device, for which no further
regulatory agency review is expected. In collaboration with Baxter, we
expect to complete this process while we prepare to roll-out the first
pathogen inactivation system for platelets."
Greg Young, corporate
vice president and president of Baxter's Fenwal business said, "CE
Mark approval of the INTERCEPT Platelets' disposable set represents more
than a decade of collaboration between Cerus and Baxter. We look forward
to working together to bring to market the first pathogen inactivation
system for platelets. We are excited about the prospects of INTERCEPT
Platelets to further enhance the safety of the blood supply."
Approximately 1.3
million platelet transfusions are performed annually in Europe to prevent
bleeding in a variety of patients, including those undergoing high-dose
chemotherapy, heart bypass surgery or general surgical procedures. While
donated platelets are tested for certain known pathogens, current testing
methods do not detect potential emerging pathogens or eliminate the risk
of viral contamination. In addition, there are no tests routinely used
to screen for bacteria, which is of particular concern as bacteria quickly
grow in nutrient-rich platelet concentrates.
Cerus and Baxter are
the only companies in clinical trials and undergoing regulatory review
for pathogen inactivation systems for all three of the primary blood components
-- platelets, plasma, and red blood cells. The companies have begun the
regulatory submission process for INTERCEPT Platelets in the United States.
The INTERCEPT Blood
System for platelets is designed to inactivate viruses, bacteria, other
pathogens and white blood cells in platelets intended for transfusion.
INTERCEPT Platelets use Cerus' light-activated Helinx® compound designed
to permanently inactivate a broad array of pathogens while preserving
the integrity and therapeutic value of the blood component.
The INTERCEPT disposable
set for platelets contains the integrated plastic components for the pathogen
inactivation and storage of INTERCEPT platelets. During the pathogen inactivation
process, platelets are mixed in the disposable set with the Helinx compound.
The platelet container is then placed in the illumination device, where
it is exposed to UVA light that activates the compound.
The Helinx compound,
when activated, binds to and crosslinks nucleic acids (DNA and RNA) in
viruses, bacteria and other pathogens, rendering them unable to multiply.
These proprietary compounds also prevent the proliferation of white blood
cells, which are associated with a variety of adverse transfusion reactions.
Following light exposure, the by-products of the pathogen inactivation
process are removed and the INTERCEPT platelets are transferred to the
final bag where they are stored under normal platelet storage conditions
until transfusion. Mature platelets, plasma and red blood cells do not
contain DNA or RNA, and therefore are not targeted by the INTERCEPT process.
Cerus Corporation
is developing medical systems and therapeutics based on its proprietary
Helinx technology for controlling biological replication. Cerus' most
advanced programs are focused on systems to enhance the safety of blood
products used for transfusion. The INTERCEPT Blood Systems, based on the
Cerus Helinx technology, are being developed to inactivate viruses, bacteria,
parasites and white blood cells. The Concord, California-based company
also is pursuing therapeutic applications
of Helinx technology to treat and prevent serious diseases.
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 cancer, hemophilia, immune deficiencies,
infectious diseases, kidney disease and trauma.
(Helinx is a U.S.
registered trademark of Cerus Corporation)
(INTERCEPT is a trademark of Baxter International Inc.)
Statements in this
news release regarding regulatory filings, product development and commercial
potential are forward-looking statements that involve risks and uncertainties.
Actual results could differ materially from the above forward-looking
statements as a result of certain factors, including the risks and uncertainty
of the timing and results of clinical trials and other development activities,
actions by regulatory authorities at any stage of the development process,
additional financing activities, manufacturing, market acceptance of any
products, competitive conditions and other factors discussed in the companies'
most recent filings with the Securities and Exchange Commission.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Cerus Corporation
Sylvia Wheeler, 925-288-6061
Baxter Healthcare Corporation
Jed Weiner, 847-270-3928, North America
Tanya Tyska, 847-948-3256, North America
Patty O'Hayer, 011 32 2 650 1924, Europe
- Investor Contacts:
- Cerus Corporation
Sylvia Wheeler, 925-288-6061
Baxter Healthcare Corporation
Neville Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
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