Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical...

Bayer Announces Leukine(R) Data Presentations at 45th American Society of
Clinical Oncology (ASCO) Annual Meeting

WAYNE, N.J., May 29 /PRNewswire/ -- Bayer Healthcare Pharmaceuticals Inc.
today announced that several studies evaluating the use of Leukine(R)
(sargramostim) will be presented at the 2009 American Society of Clinical
Oncology (ASCO) Annual Meeting.

"We are excited to see that several studies of Leukine have been accepted at
ASCO," said Pam Cyrus, MD, vice president, Medical Affairs, Oncology, Bayer
HealthCare Pharmaceuticals.

Abstracts are now available on the ASCO Web site at www.abstract.asco.org.

Leukine data highlights include the following:

Chemotherapy-Induced Neutropenia
-- Budget impact analysis of sargramostim use in patients with
chemotherapy-induced neutropenia
-- Lead investigator: M. Duh, Analysis Group, Inc., Boston, MA

-- Abstract e20596, Publication only

Melanoma
-- Immunological effects and clinical outcomes in patients with high-risk
melanoma given adjuvant therapy with granulocyte-macrophage colony
stimulating factor (GM-CSF, sargramostim)
-- Lead investigator: Lynn Spitler, Northern California Melanoma
Center, Saint Mary's Medical Center, San Francisco, CA

-- Abstract e20004, Publication only

Follicular Lymphoma
-- Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first
complete remission: Phase III clinical trial results
-- Lead investigator: S. J. Schuster, Abramson Cancer Center,
University of Pennsylvania, Philadelphia, PA

-- Abstract 2, Plenary Presentation, Sunday, May 31, 1:00 PM to 4:00
PM, Level 2, West Hall D2

Neuroblastoma
-- A phase III randomized trial of the chimeric anti-GD2 antibody ch14.18
with GM-CSF and IL2 as immunotherapy following dose intensive
chemotherapy for high-risk neuroblastoma: Children's Oncology Group
(COG) study ANBL0032
-- Lead investigator: A. L. Yu, Children's Oncology Group

-- Abstract 10067z, Oral Presentation, Tuesday, June 2, 8:00 AM to
10:45 AM, Level 3, W304E

About Leukine(R)
Leukine(R) (sargramostim) is the only growth factor approved in the U.S. for
use following induction chemotherapy in older adults (older than 55) with
acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery
and reduce the incidence of severe and life-threatening infections and
infections resulting in death. Leukine also has been approved in the U.S. for
use in four additional indications: myeloid reconstitution following
allogeneic and autologous bone marrow transplantation (BMT), peripheral blood
stem cell (PBSC) mobilization and subsequent myeloid reconstitution in
patients undergoing PBSC transplantation and bone marrow transplantation
failure or engraftment delay. Leukine is available in two formulations, both
of which are suitable for IV infusion and subcutaneous injection:
-- Liquid: 500 mcg/mL sterile solution in multi-use vial

-- Lyophilized powder: 250 mcg in single-use vial ready for sterile
reconstitution

Among its indications, Leukine is the only myeloid growth factor approved to
reduce the incidence of infections resulting in early death following
induction chemotherapy in older adults with AML.

Important Safety Considerations
Leukine is contraindicated in patients with excessive leukemic blasts in bone
marrow or peripheral blood (10 percent), in patients with known
hypersensitivity to GM-CSF, yeast derived products or any component of
Leukine, and for concomitant use with chemotherapy and radiotherapy. Serious
allergic or anaphylactic reactions have been reported with Leukine. If any
serious or anaphylactic reactions occur, Leukine therapy should immediately be
discontinued and appropriate therapy initiated. Leukine should be used with
caution and monitored in patients with preexisting fluid retention, pulmonary
infiltrates or CHF; respiratory symptoms or disease; cardiac symptoms or
disease; and renal or hepatic dysfunction. Edema, capillary leak syndrome,
pleural and or/pericardial effusion, supraventricular tachycardia,
sequestration of granulocytes in the pulmonary circulation and dyspnea have
been reported in patients after Leukine administration. Leukine has induced
the elevation of serum creatinine or bilirubin and hepatic enzymes in some
patients. Monitoring of renal and hepatic function in patients with
preexisting renal or hepatic dysfunction is recommended at least every other
week during Leukine administration. Adverse events occurring in 10 percent of
AML patients receiving Leukine in controlled clinical trials and reported in a
higher frequency than placebo were: fever, skin reactions, metabolic
disturbances, nausea, vomiting, weight-loss, edema, and anorexia. If ANC
20,000 cells/mm3 or if platelet counts 500,000 mm3, Leukine administration
should be interrupted or the dose reduced by half. Twice weekly monitoring of
CBC with differential should be performed. Leukine therapy should be
discontinued if disease progression is detected during treatment.

For more information about Leukine, including full prescribing information,
visit www.leukine.com.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit
of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading,
innovative companies in the healthcare and medical products industry, Bayer
HealthCare combines the global activities of the Animal Health, Consumer Care,
Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's Healthcare,
Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and
Oncology. The company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and treating
diseases.

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 annual and interim reports to the
Frankfurt Stock Exchange and in our reports filed 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.

Media Contact:

-- David Freundel: Bayer HealthCare Pharmaceuticals, (973) 305-5310,
david.freundel@bayer.com

SOURCE Bayer Healthcare Pharmaceuticals Inc.

David Freundel, Bayer HealthCare Pharmaceuticals, +1-973-305-5310,
david.freundel@bayer.com