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BAXTER'S
NEWEST PERITONEAL DIALYSIS SOLUTION -- EXTRANEAL (ICODEXTRIN) -- APPROVED
FOR SALE IN JAPAN
EXTRANEAL Leads
Expansion of Baxter's Global Portfolio of Products for Kidney Disease
DEERFIELD, Ill., May
6, 2003 -- Baxter Healthcare Corporation announced today that the Japanese
Ministry of Health, Labor and Welfare (JMHLW) has approved EXTRANEAL (icodextrin),
a peritoneal dialysis (PD) solution, in Japan. This solution offers the
potential for increased removal of fluid from the bloodstream during dialysis
(known as ultrafiltration) over currently available 1.5 and 2.5 percent
dextrose solutions in Japan, during long-dwell dialysis exchanges. EXTRANEAL
is the first solution with a new class of osmotic agent introduced for
PD patients.
"We are committed
to continually delivering new therapeutic improvements to help people
with kidney disease," said Alan L. Heller, senior vice president
and president of Baxter's global Renal business. "The launch of EXTRANEAL
in Japan and recently in the United States, will expand Baxter's offering
of dialysis treatments globally."
EXTRANEAL's indication
in Japan and the United States is for a single, daily exchange for long
dwell in peritoneal dialysis in patients with chronic renal failure. "Dwell"
is the amount of time dialysis solution remains in the abdominal cavity
during PD therapy, which is usually performed in the home. "Exchange"
refers to the process of discarding used dialysis solution and instilling
fresh dialysis solution into the abdominal cavity.
Prior to EXTRANEAL,
available dialysis solutions used glucose as the osmotic agent, which
acts as the driving force in the removal of fluid from the bloodstream.
EXTRANEAL solution uses a novel osmotic agent that is a polymer of glucose
to remove greater amounts of fluid over the long-dwell period compared
to standard 1.5 and 2.5 percent dextrose solutions. During long-dwell
dialysis exchanges with solutions other than EXTRANEAL, more dialysis
fluid may be absorbed into the bloodstream than is removed by ultrafiltration,
which translates into less effective fluid removal. Fluid removal is a
cornerstone of dialysis therapy, since the patient's native kidneys have
limited, if any, residual ability to eliminate excess fluid from the bloodstream.
"Regrettably,
many otherwise successful PD patients lose their ability to eliminate
fluid, normally removed during dialysis. These patients suffer ultrafiltration
failure and many are forced to prematurely discontinue PD as their preferred
form of therapy. EXTRANEAL approval in Japan offers an exciting, novel
opportunity for nephrologists to enhance ultrafiltration for these patients.
This can be done without having to resort to higher glucose-containing
dialysis solutions with their related concerns," said William Owen,
Jr., M.D., chief scientist, Baxter's global Renal business. "The
increased global presence of our specialty PD solutions, like EXTRANEAL,
as part of our comprehensive clinical management approach to PD expands
options to optimize the treatment of end-stage renal disease."
EXTRANEAL is currently
approved for marketing in 36 countries, including recent approvals in
Taiwan and the United States. More than 10,000 patients are currently
using the solution worldwide. The solution is expected to be available
in Japan in the second half of 2003.
EXTRANEAL is contraindicated
in patients with a known allergy to cornstarch or icodextrin or in patients
with glycogen storage disease. In clinical trials in the United States
and Europe, the most frequently reported adverse events occurring in less
than 10 percent of patients, were peritonitis, upper respiratory infection,
hypertension and rash. These adverse events also were observed in control
patients, although less commonly. The most common treatment-related adverse
event for EXTRANEAL patients was skin rash.
Since falsely elevated
glucose levels have been observed with blood glucose monitoring devices
and test strips that use glucose dehydrogenase pyrroloquinolinequinone
(GDH-PQQ)-based methods, these should not be used to measure glucose levels
in patients administered EXTRANEAL. Patients with insulin-dependent diabetes
may require modification of insulin dosage following initiation of treatment.
For more information on EXTRANEAL, including prescribing information,
see www.baxter.com/extraneal.
ESRD and Treatment
Background
As chronic kidney disease progresses to end-stage renal disease (ESRD),
the kidneys are irreversibly damaged and can no longer effectively fulfill
their role of filtering and removing wastes, toxins and fluid from the
body. Without some form of renal replacement therapy, death will ensue
within days or weeks. Treatment options for ESRD include kidney transplantation,
hemodialysis (HD), and peritoneal dialysis (PD). PD, unlike HD, does not
require that blood leave the body during dialysis. Rather, removal of
accumulated wastes, and fluid are accomplished by filtration across the
abdominal lining, the peritoneum. Acting as a natural or biological filter,
fluid is entered into the abdomen through a surgically placed soft, flexible
plastic tube. Wastes and excessive fluid that build up in the body pass
from the blood into dialysis solution. The solution, which now contains
the toxins and waste fluids, is drained from the abdomen through the tube,
and fresh fluid is infused.
In the United States,
more than 300,000 people, or more than one in 1,000 people, are being
treated for ESRD. The number of people being treated for ESRD in the United
States is growing approximately six percent annually. In Japan, approximately
220,000 ESRD patients are being treated with some form of dialysis.
Baxter is a leading
provider of renal products and services worldwide. In 1956, the company
introduced the first disposable coil dialyzer, a development that greatly
enhanced the use and application of hemodialysis. Nearly 20 years later,
Baxter was the first company to introduce continuous ambulatory peritoneal
dialysis products.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc., (NYSE: BAX), 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.
(BAXTER and EXTRANEAL
are trademarks of Baxter International Inc. and its affiliates.)
This news release
contains forward-looking statements that involve risks and uncertainties,
including product demand and market acceptance, the impact of competitive
products and pricing, and other risks detailed in the company's filings
with the Securities and Exchange Commission. These forward-looking statements
are based on estimates and assumptions made by management of the company
and are believed to be reasonable, though are inherently uncertain and
difficult to predict. Actual results or experience could differ materially
from the forward-looking statements.
FOR
ADDITIONAL INFORMATION:
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Media Contacts:
Ilke Arici, Baxter, 847-948-3272
Cindy Resman, Baxter, 847-948-2815
Investor Contacts:
- Neville Jeharajah,
Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-3371
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