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News Release

FDA APPROVES EXTRANEAL (ICODEXTRIN), BAXTER'S NEW
PERITONEAL DIALYSIS SOLUTION

EXTRANEAL Expands Options for Effective Fluid Management-A Primary Goal for Home-based Peritoneal Dialysis

First Solution with New Class of Osmotic Agent in United States

DEERFIELD, Ill., December 23, 2002 -- Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved EXTRANEAL (icodextrin), a peritoneal dialysis (PD) solution. This solution offers the potential for increased removal of fluid from the blood stream during dialysis (known as ultrafiltration) over currently available 1.5% and 2.5% dextrose solutions during long dwell dialysis exchanges. EXTRANEAL is the first solution with a new class of osmotic agent introduced for PD patients in the United States.

"I am excited about the FDA's approval of EXTRANEAL, which gives physicians a new approach to addressing fluid management issues for numerous peritoneal dialysis patients in the United States," said John Burkart, M.D., Professor of Internal Medicine and Director of Outpatient Dialysis, Nephrology Division at Wake Forest University School of Medicine, North Carolina. "Effective fluid management or ultrafiltration is a primary goal of PD therapy, and now with the introduction of EXTRANEAL, we can help to optimize the treatment in a new way for our patients."

EXTRANEAL is indicated for a single daily exchange for the long dwell (8- to 16-hours) during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of 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. Ultrafiltration is the removal of fluid from the bloodstream during dialysis.

Prior to EXTRANEAL, dialysis solutions available in the United States used glucose as the osmotic agent, which acts as the driving force in the removal of fluids. EXTRANEAL solution uses a novel osmotic agent, which is a polymer of glucose, to remove greater amounts of fluid over the long dwell period as compared to standard 1.5% and 2.5% dextrose solutions. During long dwell dialysis exchanges with prior solutions, more dialysis fluid may be absorbed into the blood stream 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.

Clinical Trial Results
EXTRANEAL has demonstrated efficacy as a PD solution in clinical trials of approximately 400 end-stage renal disease (ESRD) patients. Active controlled trials of one to six months in duration show that EXTRANEAL, used once daily for the long dwell in either CAPD or APD, resulted in higher net ultrafiltration compared with 1.5% and 2.5% dextrose solutions, and resulted in higher creatinine and urea nitrogen clearances compared with 2.5% dextrose solution. In a single study, ultrafiltration results with 4.25% dextrose were similar to EXTRANEAL.

"Net ultrafiltration" is an important measure of dialysis efficacy, which is calculated from the difference between the volume of solution infused at the start of the dwell period and the volume drained at its end. "Clearance" refers to the rate at which a given substance is removed from blood and is defined as the number of milliliters of blood that would be completely cleared of a given solute in a pre-determined time period.

EXTRANEAL is currently approved for marketing in 34 countries, and more than 9,000 patients are currently using the solution worldwide. The solution is expected to be available in the first quarter of 2003 in the United States.

"EXTRANEAL solution improves and expands upon peritoneal dialysis solution options for fluid management in the United States," said William F. Owen, Jr., M.D., chief scientist, Renal Division, Baxter Healthcare Corporation. "EXTRANEAL represents a significant achievement in our continued effort to develop innovative therapies for people with kidney disease."

EXTRANEAL is contraindicated in patients with a known allergy to cornstarch or icodextrin or in patients with glycogen storage disease. In clinical trials the most frequently reported adverse events occurring in >10% of patients, and more common in EXTRANEAL patients than in control patients, were peritonitis, upper respiratory infection, hypertension and rash. These were also observed in control patients. 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, view the package insert information. (Acrobat PDF)

ESRD and Treatment Background
In chronic kidney disease or ESRD, the kidneys are irreversibly destroyed by disease and can no longer effectively fulfill their role of filtering and removing wastes, toxins and fluid from the body. In PD, which is one form of dialysis, extra fluids and waste are removed from the blood inside the body, using the body's own peritoneal membrane, or abdominal lining, as a natural filter. This membrane lines the area that holds the stomach, spleen, liver and intestines. In this form of dialysis, blood never leaves the body. Dialysis fluid enters the peritoneal cavity through a flexible catheter surgically inserted in the abdomen. Extra fluid and waste travel across the peritoneal membrane into the dialysis fluid, which is then drained from the abdomen through the catheter after a pre-determined dwell period.

There are two types of peritoneal dialysis-APD and CAPD. APD is performed using a machine (cycler) for instillation and drainage of the dialysis solution, and CAPD is performed by the person using a gravity-based technique instead of using a machine.

A person performing PD will typically undergo four to six exchanges daily, of which one is usually a long-dwell exchange.

In the United States, more than 300,000 people, or just over 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 five to six percent annually. Of the estimated one million people worldwide suffering from ESRD who are treated with some form of dialysis therapy, 10 to 15 percent use peritoneal dialysis.

Baxter is a leading global manufacturer of a complete and complimentary portfolio of dialysis-related products and services designed to assist patients with kidney disease throughout the continuum of their care. For nearly 50 years, Baxter has been at the forefront of innovation in kidney care. In 1956, the company introduced the first disposable coil dialyzer, a development that greatly enhanced the use and application of hemodialysis. Years later, Baxter was the first company to introduce peritoneal dialysis products, and the company continues to introduce new products and services to help enhance the care of people with kidney disease around the world.

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 technological advances in the medical field, product demand and market acceptance, actions of regulatory bodies, 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:

Ultrafiltration Fact Sheet
Media Contacts:
    Lisa Keltner, 847-948-4107
Deborah Spak, 847-948-2349

 
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