Largest Randomized, Prospective Idiopathic [Immune] Thrombocytopenic Purpura (ITP) Study to Date Shows Gamunex(R) Safe and Effic

Largest Randomized, Prospective Idiopathic [Immune]
Thrombocytopenic Purpura (ITP) Study to Date Shows Gamunex(R) Safe and
Efficacious for Patients
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified


RESEARCH TRIANGLE PARK, N.C., June 1  /PRNewswire-FirstCall/ -- Bayer
HealthCare LLC, Biological Products Division (Bayer BP), announced today that
recently published data surrounding its novel IGIV, Gamunex(R), Immune Globulin
Intravenous (Human), 10% Caprylate/Chromatography Purified, met both primary
and secondary endpoints for safety and efficacy in an evaluation of the drug's
use in the treatment of ITP (Idiopathic [immune] Thrombocytopenic Purpura).
Gamunex was approved for the treatment of ITP and other indications in the
United States and Canada in August 2003, as well as in Germany earlier this
year.

The primary endpoint was to achieve similar platelet count elevation after
treatment with Gamunex compared with standard treatment, IGIV- S/D. Ninety
percent of patients who were treated with Gamunex achieved target platelet
counts within seven days of dosing compared to 83 percent in the IGIV-S/D
group. The secondary endpoint was to maintain platelet counts for at least
seven days, which 74 percent of the Gamunex group achieved compared with 60
percent of the IGIV-S/D control group.

A Personal Account of Idiopathic [immune] Thrombocytopenic Purpura

ITP is an autoimmune disorder of unknown cause that affects both children and
adults. In children, it is usually an acute, temporary condition with rapid
onset typically following an infection. In adults, ITP is a chronic condition
distinguished by a severe onset. ITP occurs when the immune system malfunctions
and produces antibodies against the body's own platelets. These antibodies
destroy the platelets, resulting in a decreased level of blood platelets needed
for normal blood clotting. Characterized by a low platelet count,
notwithstanding normal bone marrow production and the absence of other specific
causes (such as leukemia or aplastic anemia), ITP can lead to life- threatening
bleeding episodes.

Retired NASA employee, Ted Gull, experienced a typical rapid onset of ITP. "It
all started during the holiday season when I just couldn't shake the flu. Next
thing I knew, I noticed deep purple bruises on my body and persistent nose
bleeds that never seemed to end," said Gull. "A normal platelet count ranges
from 150,000 to about 400,000 platelets/mL of blood while my count was nearly
undetectable. I could have bled to death."

The disorder becomes life-threatening if a patient's platelet count becomes so
low that brain hemorrhaging occurs. Hemorrhaging is the key concern for ITP
patients. When platelet counts are too low, internal bleeding can be difficult
to stop. Rarely, life-threatening bleeding occurs with intracranial hemorrhage
or other serious hemorrhaging.

Childhood ITP is typically resolved quickly - more than 70 percent of children
with ITP will have a spontaneous and permanent remission within one year of
onset. In contrast, the majority of adults have persistent ITP, or "chronic
state" ITP, that must be treated when platelets fall below a critical level.

After several treatments failed to raise Gull's platelet count, his
hematologist prescribed a regular treatment regimen of Bayer's IGIV to keep his
platelet count within a safe range. Gull's wife, Connie, is a registered nurse,
which allows him to receive his IGIV treatments at home. "Getting infused in an
out-patient setting opened up my world again, allowing me and my wife to travel
the globe like we did before I was diagnosed," said Gull. "Not since my early
days at NASA had I felt like I had the entire galaxy at my disposal." He and
his wife recently decided to pack their bags (and their cooler to keep Gull's
IGIV refrigerated) and head to Hawaii for their 30th wedding anniversary.

Significance of Study

This study resulted in the most comprehensive prospective data on this patient
population to date. Although more than 100 studies on IGIV have been done since
1981 (the first report of the efficacy of IGIV in the treatment of ITP), most
were data analyses completed after treatment was started (retrospective data
analysis), and most were done in children. By contrast, this was a prospective
study that included both acute and chronic patients, and looked at children and
adults with ITP.

Ninety-seven patients were enrolled and randomized from 26 sites in the United
States, Canada, South Africa, and Israel. Seventy-five percent of the patients
were adults and 72 percent female. Forty-eight patients were treated with
Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography
Purified, and 49 patients were treated with IGIV-S/D as a control group.

Adverse events observed in this study were consistent with those in previous
IGIV studies, and most frequently included headache, vomiting, fever, nausea.
Most were mild to moderate. For additional information on Gamunex, see Full
Prescribing Information at http://www.gamunex.com/.

About Gamunex

Each vial of Gamunex contains antibodies purified from the donated blood plasma
of thousands of people and can be a lifesaving therapy for individuals with
compromised or malfunctioning immune systems. The immune system serves as the
body's natural defense system, constantly fighting off infections caused by
harmful bacteria and viruses that invade the body. When parts of the immune
system are missing, as in patients with primary immune deficiencies, the body
is vulnerable to attack by these invaders. In those cases, the broad spectrum
of antibodies in Gamunex acts as an immune system replacement and provides a
shield of protection against infection.

For people with autoimmune disorders and other conditions that cause the immune
system to malfunction, such as idiopathic thrombocytopenia purpura (ITP),
Gamunex acts as an immune modulator and resets the immune system so it can
function normally again.

Gamunex(R), Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography
Purified, is formulated without sugar stabilizers, which have been associated
with severe adverse reactions in other IGIV products. In addition Gamunex
offers IGIV patients the unique combination of a ready-to-use, highly purified,
10% formulation, and a safe and rapid infusion rate, giving time back to
patients and the health care providers that care for them.

About Bayer HealthCare AG

Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.3
Billion Euro in 2003, is one of the world's leading, innovative companies in
the health care and medical products industry.

The company combines the global activities of the divisions Animal Health,
Biological Products, Consumer Care, Diagnostics, and Pharmaceuticals. More than
34,000 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve
human and animal health worldwide. Our products enhance well-being and quality
of life by diagnosing, preventing, and treating disease.

Forward-looking Statements

This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties, and other factors could lead to material
differences between the actual future results, financial situation,
development, or performance of the company, and the estimates given here. These
factors include those discussed in our public reports filed with the Frankfurt
Stock Exchange and with the U.S. Securities and Exchange Commission (including
our Form 20-F). The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.


DATASOURCE: Bayer HealthCare AG



CONTACT:  Tricia McKernan of Bayer, [phone], fax,

[phone], 



Web site:  http://www.gamunex.com/ 

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