Bayer Announces Upcoming Presentations Of Campath(R) And Leukine(R) Data At The 50th Annual Meeting Of The American Society Of Hematology

Main Category: Lymphology/Lymphedema
Also Included In: Clinical Trials / Drug Trials;  Conferences;  Pharma Industry / Biotech Industry
Article Date: 06 Dec 2008 - 0:00 PDT

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Bayer HealthCare Pharmaceuticals Inc. announced that data on Campath(R) (alemtuzumab) and Leukine(R) (sargramostim) will be presented at the 50th Annual Meeting of the American Society of Hematology (ASH) from December 6-9, 2008 in San Francisco, California.

Clinical investigators from leading oncology and hematology research centers will present data through several oral and poster presentations reporting important findings in leukemia-related disorders, such as prognostic indicators for chronic lymphocytic leukemia (CLL) and side effects such as chemotherapy-induced neutropenia.

Campath is indicated in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Leukine is indicated for use following induction chemotherapy in patients 55 years and older with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death.

"We are pleased to see continued developments on both Campath and Leukine," said Pam Cyrus, Vice President, Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals. "These studies further demonstrate Bayer's ongoing commitment to supporting research to benefit the lives of people living with cancer."

Abstracts are now available on the ASH Web site at http://www.hematology.org.

Among the data that will be presented are the following:

Campath:

-- Poster 3164 (December 8, 5:30 p.m. PST) -- Clinical Outcome of B-Cell Chronic Lymphocytic Leukemia Following Alemtuzumab Therapy: Retrospective Study Within Various Cytogenetic Risk Categories

-- Poster 329 (December 8, 12:00 p.m. PST) -- Subcutaneous Alemtuzumab (Campath) in Fludarabine-Refractory CLL: Final Results of the CLL2H Trial of the GCLLSG and Comprehensive Analysis of Prognostic Markers

Leukine:

-- Oral Presentation 665 (December 8, 3:30 p.m. PST) -- Comparison of Infection-Related Hospitalization Risk and Associated Costs Among Patients Receiving Sargramostim (Leukine), Filgrastim (Neupogen), and Pegfilgrastim (Neulasta) for Chemotherapy-Induced Neutropenia

-- Poster 3173 (December 8, 5:30 p.m. PST) -- Experience with Fludarabine, Cyclophosphamide, Rituximab (FCR) Plus GM-CSF in Frontline Therapy for Chronic Lymphocytic Leukemia (CLL)

About Campath

Campath was the first monoclonal antibody approved by the United States Food and Drug Administration (FDA) for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). In September 2007, the FDA approved a supplemental Biologics License Application (sBLA) for Campath and granted regular approval for single-agent Campath for the treatment of B-CLL. Campath was initially approved in 2001 under accelerated approval regulations for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Campath was developed by Genzyme Corporation. Campath is marketed in the U.S. by Bayer HealthCare Pharmaceuticals Inc., as Campath, and outside the United States as MabCampath(R).

Important Safety Information

WARNING: CYTOPENIAS, INFUSION REACTIONS, AND INFECTIONS

-- Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30mg or cumulative doses greater than 90mg per week increase the incidence of pancytopenia.

-- Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days.

-- Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections.

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is administered as an IV infusion over two hours and should be dose escalated to recommended dose of 30 mg/day three times per week for 12 weeks. Patients are premedicated with oral antihistamine and acetaminophen prior to dosing. The most commonly reported adverse reactions are infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

About Leukine

Leukine is a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. Leukine was approved in the United States in 1991 and is marketed by Bayer HealthCare Pharmaceuticals. Leukine is the only growth factor approved in the U.S. for use following induction chemotherapy in older adults 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

Leukine has been used to treat nearly 250,000 cancer patients in the U.S. since 1991. 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.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare, an affiliate 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 United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and reported revenues in 2007 of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme(R), Campath(R) and MabCampath(R) are registered trademarks of Genzyme Corporation. All rights reserved.

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.

Bayer HealthCare Pharmaceuticals Inc.
http://www.pharma.bayer.com

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