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EXHIBIT 99.1
Contacts:
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Greg W. Schafer Margaret Shubny Bethanee Martin
Cerus Corporation Baxter Healthcare Corp. Edelman Public Relations Worldwide
(925) 603-9071 (847) 948-3951 (415) 486-3235
[email protected] [email protected] [email protected]
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CERUS AND BAXTER ANNOUNCE RESULTS OF EUROPEAN PHASE 3
TRIAL OF THEIR INTERCEPT PLATELET SYSTEM FOR
PATHOGEN INACTIVATION
DATA SUPPORTS SUBMISSION FOR EUROPEAN REGULATORY APPROVAL
CONCORD, CALIF. AND DEERFIELD, ILL., AUGUST 22, 2000 - Cerus Corporation
(NASDAQ: CERS), a pioneer in systems to enhance the safety of the blood supply,
and its development partner, Baxter Healthcare Corporation, announced today that
the results of their European Phase 3 clinical trial of the Intercept Platelet
System support a planned submission for regulatory approval to market the system
in Europe. The companies are developing Intercept Blood Systems to protect
against the transmission of infectious diseases through blood transfusions. The
Intercept Platelet System is the only pathogen inactivation system for platelets
to enter human clinical trials.
The 103 patient study was designed to assess the therapeutic efficacy and safety
of platelets treated with the Intercept Platelet System. Patients also were
monitored for bleeding, acute transfusion reactions and other adverse events.
The purpose of the study was to determine whether platelets treated with the
Intercept Platelet System provide platelet transfusion support consistent with
current medical practice. The study included platelet-deficient cancer patients
in four academic medical centers in the United Kingdom, France, the Netherlands
and Sweden.
"This study shows that physicians can provide their patients the added security
of pathogen-inactivated platelets while delivering the therapeutic benefits
required of platelet transfusions," said Dr. D. van Rhenen of Bloodbank
Rotterdam, the Netherlands, the lead investigator on the study.
The trial had two primary endpoints: corrected count increment and platelet
count increment, each one-hour after transfusion. The corrected count increment
measures the increase in the patient's platelet count after a platelet
transfusion, corrected for transfusion platelet dose and the patient's blood
volume. For this measure, one-hour after transfusion, the performance of treated
platelets was similar to that of the untreated platelets.
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The platelet count increment, which measures the platelet count increase without
correcting for dosage or blood volume, is influenced by the platelet dose the
patient receives. In this study the platelet dose per transfusion of treated
platelets was approximately ten percent lower than that of untreated platelets.
The resulting platelet count increment one-hour after transfusion of treated
platelets was statistically lower than that after transfusion of untreated
platelets. However, both the platelet dose per transfusion and the platelet
count increment one hour after transfusion were within the typical therapeutic
range reported in medical literature for untreated platelets.
Secondary endpoints for the study included multiple factors relevant to clinical
efficacy and safety. The results for two important indicators of clinical
efficacy, the number of patients with a major bleeding episode and the number of
red blood cell transfusions, were comparable for the treated and untreated
platelets. Similarly, the time between platelet transfusions, the total platelet
dose per patient and the number of adverse events were similar between the two
groups. Both the platelet count increment and the corrected count increment
measured 24 hours after transfusion, while statistically lower than those
following the transfusion of untreated platelets, were within the typical
therapeutic range reported in medical literature for untreated platelets.
"This is a pivotal step in our mission to enhance the safety of the blood
supply," said Stephen Isaacs, Cerus president and chief executive officer. "The
Intercept Platelet System is paving the way in our comprehensive approach to the
inactivation of pathogens in all three transfusion blood components."
"We are pleased with the results of this study. Baxter and Cerus expect to be
the first to file for regulatory approval of a pathogen inactivation system for
platelets," stated Harry M. Jansen Kraemer, Jr. Baxter chairman and chief
executive officer. "This is a significant step forward in our pathogen
inactivation programs."
Intercept Blood Systems are designed to inactivate viruses, bacteria and other
pathogens, as well as white blood cells, which have been associated with a
variety of transfusion reactions. Intercept Blood Systems are based on Cerus'
proprietary Helinx technology, which has been developed to inactivate
blood-borne pathogens while leaving the therapeutic properties of the blood
component intact. Previous studies have demonstrated the ability of the Helinx
technology to inactivate a broad array of pathogens that may be present in blood
products.
The companies are conducting a 600 patient Phase 3 clinical trial of the
Intercept Platelet System in the United States. A Phase 3 clinical trial of the
Intercept Plasma System and Phase 1 clinical trials of the Intercept Red Blood
Cell System are also underway in the United States.
Cerus and Baxter are submitting the results of the European Phase 3 clinical
trial for presentation at the annual meeting of the American Society of
Hematology in December 2000.
ABOUT CERUS
Cerus Corporation is developing systems to enhance the safety of the world's
blood supply. These systems are based on Cerus' Helinx technology, which has the
ability to prevent the replication of viruses, bacteria and other pathogens and
to control cellular proliferation. The Concord, Calif.-based biopharmaceutical
company is currently conducting the first human
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clinical trials of pathogen-inactivated platelets, as well as clinical trials of
fresh frozen plasma (FFP) and red blood cells, in collaboration with Baxter
Healthcare Corporation.
ABOUT BAXTER
Baxter Healthcare is the principal domestic operating subsidiary of Baxter
International (NYSE: BAX). Baxter International, through its subsidiaries, is a
global medical products and services company that provides critical therapies
for people with life-threatening conditions. The company's products and services
in bioscience (biopharmaceuticals and blood collection, separation and storage
devices), medication delivery and renal therapy are used by health-care
providers and their patients in more than 100 countries.
Helinx is a trademark of Cerus Corporation.
Intercept Blood System, Intercept Platelet System, Intercept Plasma System and
Intercept Red Blood Cell System are trademarks of Baxter International, Inc.
Statements in this news release regarding product development, clinical
development and regulatory activity 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
uncertainty of the timing and results of any clinical trials, action by
regulatory authorities, the lack of assurance of product approval, the
uncertainty of market acceptance of any products, competitive conditions, the
uncertainty of future financing and other factors discussed in the companies'
1999 Annual Reports on Form 10-K. More detailed information on the results of
the European Phase 3 Trial are contained in a report on Form 8-K, being filed
with the Securities and Exchange Commission by Cerus concurrently with this news
release.
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For more information about Cerus, call (925) 603-9071.
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