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BAXTER AND CERUS ANNOUNCE FINAL EUROPEAN REGULATORY CLEARANCE FOR THE
FIRST PATHOGEN INACTIVATION SYSTEM FOR PLATELETS
INTERCEPT Blood
System Developed to Make Blood Transfusions
Safer for Patients
DEERFIELD, Ill. and
CONCORD, Calif., October 16, 2002 - Subsidiaries of Baxter International
Inc. (NYSE:BAX), and Cerus Corporation (Nasdaq: CERS) today announced
CE Mark declaration for the illuminator device for the INTERCEPT Blood
System. This represents the final regulatory step before this first pathogen
inactivation technology for platelets is available in Europe.
The INTERCEPT Blood
System is designed to protect patients by reducing the risk of transfusion-transmitted
diseases through blood transfusions by inactivating certain known and
potential emerging pathogens in blood components. Application of this
technology to platelets is the first to be approved and clinical trials
are underway for use with plasma and red blood cells for transfusion,
making the INTERCEPT Blood System the only pathogen inactivation technology
being developed for use with all primary blood components.
The INTERCEPT Blood
System goes a step beyond current blood safety measures, which test for
certain infectious diseases, by inactivating a broad spectrum of pathogens,
including viruses, bacteria, parasites and potentially harmful donor white
blood cells in platelets intended for transfusion. The system consists
of the illuminator device and a processing set containing a light-activated,
nucleic acid-targeting Helinx® compound, which has the ability to
permanently inactivate pathogens in the blood component. INTERCEPT Platelets
are expected to benefit hundreds of thousand of patients each year in
Europe, including those undergoing chemotherapy, heart bypass surgery
and other procedures that require platelet transfusions.
"European regulatory
approval for INTERCEPT Platelets represents an important accomplishment
in Baxter's and Cerus' efforts to make the blood supply safer for patients
worldwide," said Greg Young, corporate vice president and president
of Baxter's Fenwal division. "It also represents the successful efforts
of Baxter and Cerus, leveraging the technical expertise of both as well
as Baxter's extensive experience in transfusion therapies, in developing
a prospective approach to blood safety. We look forward to working with
blood centers and physicians across Europe to make INTERCEPT Platelets
available to patients and reduce the risk of transfusion-transmitted diseases."
"The availability
of INTERCEPT Platelets in Europe provides a new level of security for
patients and the blood community as a whole," said Stephen T. Isaacs,
president and chief executive officer of Cerus. "This approval is
a testament to the Baxter and Cerus partnership and an important milestone
for the application of Cerus' Helinx technology to inactivate certain
known and potential emerging pathogens."
As a new blood banking
technology, the INTERCEPT Blood System for platelets is required to undergo
process validations in compliance with European Blood Bank GMP requirements
at the individual country level throughout Europe before it is available
to patients. This is underway in countries including Denmark, France,
Germany, Sweden and the United Kingdom.
In Europe, physicians
perform approximately 1.3 million platelet transfusions annually, with
many patients receiving multiple units of platelets during the course
of their therapies. Despite the introduction of blood screening and testing
measures, patients remain at risk for infection and transfusion-associated
reactions. Of particular concern is bacterial contamination, especially
in nutrient-rich platelet concentrates that need to be stored at room
temperature, which can contribute to the rapid growth of bacteria. Experts
estimate that up to one in 2,000 random donor platelets or apheresis platelets
are contaminated with bacteria1,2. According to data reported in the United
Kingdom's Serious Hazards in Transfusion (SHOT) program, 12.5 percent
of transfusion-related fatalities from 1995 to 2000 were due to bacterial
contamination. Today, aside from a test for syphilis, no tests are routinely
used to screen for bacteria.
While there are tests
for many well-known viruses, such as HIV, hepatitis C and cytomegalovirus
(CMV), they can fail to detect viruses during a window period of risk
after a virus invades a donor's blood. Emerging viruses also are a potential
threat, as they appear every three to five years and it may take several
years to develop a test. Since 1994, at least five new viruses have been
identified that may impact blood safety3,4,5,6, and so far this year the
West Nile virus has infected thousands of people in the United States
and killed more than 100.
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.
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.
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.
Cerus and Helinx are
U.S. registered trademarks of Cerus Corporation.
Baxter and INTERCEPT are trademarks 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 and
commercialization 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.
The following cites
sources for scientific information referenced above. However, some of
the statistics have several sources, with the below listing only a few.
1 Reading FC, Brecher
ME. Transfusion-related bacterial sepsis. Curr Opin Heatol. 2002; 8:380-386
2 Dykstra A, Jacobs M., Yomtovian R. Prospective microbiologic surveillance
(PMS) of random donor (RDP) and single donor apheresis platelets (SDP)
{abstract}. Transfusion. 1998; 38 (suppl): 104S.
3 Parquet MC, Yatsuhashi H, Koga M. Prevalence and clinical characteristics
of TT virus (TTV) in patients with sporadic acute hepatitis of unknown
etiology. J Hepatol. 199, 31:985-986.
4 Bowden S. New hepatitis viruses: contenders and pretenders. J Gastroenterol
Hepatol. 2001; 16:124-131.
5 Sheng L, Soumillion A, Beckers N, et al. Hepatitis G virus infection
in acute fulminant hepatits: prevalence of HGV infection and sequence
analysis of a specific viral strain. J Viral Hepat. 1998;5:301-306.
6 Boneschi V, Brambilla L, Berti E, et al. Human herpes virus 8 DNA in
the skin and blood of patients with Mediterranean Kaposi's sarcome: clinical
correlations. Dermatology. 2001;203:19-23.
THIS PRESS RELEASE
IS ALSO AVAILABLE IN THE FOLLOWING LANGUAGES:
FOR ADDITIONAL
INFORMATION:
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- For Cerus
- Media
Contacts and Investor Relations:
- Sylvia
Wheeler, (925) 288-6061
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For Baxter
- Media
Contacts:
- Tanya Tyska,
(847) 948-3256, North America
Jed Weiner, (847) 270-3928, North America
Patty O'Hayer, 32 2 650 1924, Europe
- Investor Contacts:
- Neville
Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
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