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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
June 2, 1998
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Date of Report
BAXTER INTERNATIONAL INC.
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation)
1-4448 36-0781620
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(Commission file number) (IRS Employer Identification No.)
One Baxter Parkway, Deerfield, Illinois 60015
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (847) 948-2000
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(Page 1 of 5 pages)
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Item 5. Other Events.
On June 2, 1998, the attached press release was issued.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
BAXTER INTERNATIONAL INC.
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(Registrant)
By: /S/ Jan S. Reed
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Jan S. Reed
Secretary
Date: June 2, 1998
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FOR IMMEDIATE RELEASE
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Media contacts: Mary Thomas, (847) 948-2815
Jean-Pierre Hambursin, in Europe, +33 6 07 32 80 41
Investor contacts: Neville Jeharajah, (847) 948-2875
Mary Kay Ladone, (847) 948-3371
BAXTER SUSPENDS EUROPEAN TRAUMA TRIAL FOR ITS
HEMOGLOBIN THERAPEUTIC
Decision will Delay Receiving Marketing Clearance
DEERFIELD, Ill., June 2, 1998 -- Baxter Healthcare Corporation announced today
that it has suspended enrollment in its European clinical trial investigating
its oxygen-carrying solution, HemAssist(R)(DCLHb), in patients suffering from
severe trauma. Baxter has suspended the trial, which had enrolled 117 patients,
to further analyze the data gathered to date and assess if the trial as
currently designed can meet the established endpoints for efficacy. Baxter said
this decision will delay the company's ability to receive marketing clearance
for HemAssist(R)(DCLHb) in the United States or Europe, which it had been
expecting by late 1999 or early 2000.
Baxter will continue to work with its clinical investigators and the European
regulatory authorities to determine its options. The company and its clinical
investigators continue to believe that an oxygen-carrying hemoglobin therapeutic
can meet the acute medical needs of patients in a variety of indications.
In previous clinical trials, more than 500 patients have received
HemAssist(R)(DCLHb) and its safety profile has been well-established. Baxter's
U.S. Phase III trial in patients undergoing elective surgery is continuing to
accrue patients.
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Baxter Healthcare Corporation is the principal domestic operating subsidiary of
Baxter International Inc. Baxter International is a global medical-products and
services company that is a leader in technologies related to the blood and
circulatory system. Through its subsidiaries, Baxter has market-leading
positions in four global businesses: blood therapies, which develops therapies
and products used in transfusion medicine; cardiovascular medicine, which
develops products and provides services to treat late-stage cardiovascular
disease; renal therapy, which develops products and services to improve
therapies for treating kidney disease; and intravenous systems/medical products,
which develops technologies and systems to improve intravenous medication
delivery, and distributes medical products.
This news release includes forward-looking statements that involve risks and
uncertainties, including technological advances in the medical field, product
demand and market acceptance, the effect of economic conditions, the impact of
competitive products and pricing, foreign currency exchange rates and other
risks detailed in the company's filings with the Securities and Exchange
Commission. These forward-looking statements are made as of the date of this
release. All of 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.
