*BAXTER <BAX.N> SAYS SUSPENDS EUROPEAN TRIAL FOR HEMOGLOBIN THERAPEUTI
06/02 07:45 Baxter Suspends European Trauma Trial for its Hemoglobin
Therapeutic<BAX.N>
Baxter Suspends European Trauma Trial for its Hemoglobin Therapeutic
Decision will Delay Receiving Marketing Clearance
DEERFIELD, Ill., June 2 /PRNewswire/ -- 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.
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
*BAXTER <BAX.N> SAYS SUSPENDS EUROPEAN TRIAL FOR HEMOGLOBIN THERAPEUTI
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