B-cell Chronic Lymphocytic Leukemia (B-CLL): Expanded Labeling for MabCampath in Europe

BERLIN, Jan. 3, 2008 – The European Commission has granted marketing authorization to MabCampath® (alemtuzumab) for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate. MabCampath works in an entirely different way than chemotherapy, and is the first and only monoclonal antibody approved in Europe for the treatment of B-CLL, the leading form of adult leukemia in the Western hemisphere. MabCampath is jointly developed by Bayer Schering Pharma AG, Germany, and Genzyme. Bayer Schering Pharma AG, Germany, holds exclusive worldwide marketing and distribution rights to alemtuzumab and participates with Genzyme in the design of clinical protocols for the development of alemtuzumab.

“The data supporting this marketing authorization showed that MabCampath produced a higher response rate than that seen in patients with chronic lymphocytic leukaemia for any single agent in previous front-line trials,” said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, United Kingdom, lead investigator of the pivotal study supporting the application for the expanded indication (first-line B-CLL [CAM307]). “With its demonstrated efficacy and manageable safety profile, MabCampath has the potential to become an important treatment option in Europe for patients with B-CLL for whom fludarabine combination chemotherapy is not appropriate.”

The decision by the European Commission to grant extended marketing authorization to MabCampath was based on data from the CAM307 study, an international open-label Phase III randomized trial comparing MabCampath with chlorambucil in previously untreated patients with B-CLL. The study met its primary endpoint by demonstrating superior progression free survival (PFS) in patients treated with MabCampath versus chlorambucil, with MabCampath reducing the risk of disease progression or death by 42 percent (p=0.0001). Patients receiving MabCampath also exhibited higher overall and complete response rates with a manageable safety profile, compared to patients who were treated with chlorambucil. Results from this study also demonstrated that patients treated with MabCampath achieved extended treatment-free intervals, with a median period of two years before requiring additional therapy.

“As a company with clear ambitions to grow in oncology, our goal is to continue improving the lives of those touched by cancer through innovation in targeted cancer therapies,” said Gunnar Riemann, Ph.D., member of the Board of Management of Bayer Schering Pharma AG. “The European Union label extension of MabCampath for patients with B-CLL is a prime example of this.”

“The data that supported this label expansion add to a growing body of evidence about the effectiveness of MabCampath as a single-agent treatment for B-CLL,” stated Mark Enyedy, president of Genzyme Corporations’s oncology business unit. “The approval also marks an important step in a long-term development plan that is exploring the full potential of MabCampath in high-risk CLL, combination and consolidation therapy.”

In September, the United States Food and Drug Administration approved a supplemental Biologics License Application (sBLA) for alemtuzumab (trademarked as Campath in the U.S.) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (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.

About Chronic Lymphocytic Leukemia
CLL is the most prevalent form of adult leukemia, affecting approximately three out of every 100,000 people in the Western hemisphere. The disease is most commonly diagnosed among people age 50 or older and is characterized by the accumulation of functionally immature white blood cells (lymphocytes) in the bone marrow, blood, lymph tissue, and other organs. Two types of lymphocytes are present in the blood, B cells and T cells. The majority of this patient population (95 percent) suffers from a subtype called B-cell chronic lymphocytic leukemia, or B-CLL. Because these cancerous B cells have a longer than normal life span, they begin to build up and “crowd out” the normal, healthy blood cells. The accumulation of functionally immature cells in the bone marrow excludes the generation of healthy cells and can become fatal. Symptoms include fatigue, bone pain, night sweats, fevers, and decreased appetite and weight loss. Bone marrow infiltration leads to a lack of healthy blood cells, thus leading to fatigue, susceptibility to bleedings and weakening of the immune system, exposing the patient to a higher risk of infection.

About MabCampath
MabCampath (alemtuzumab) works in an entirely different way than chemotherapy. MabCampath works by targeting CD52, an antigen found on the surface of B cells - the most common cells found in CLL. When MabCampath binds to this antigen, it activates the immune system to destroy these targeted cells, while sparing crucial stem cells.

Bayer Schering Pharma AG, Germany, and Genzyme are developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany, holds exclusive worldwide marketing and distribution rights to alemtuzumab and participates with Genzyme in the design of clinical protocols and conduct of activities for the development of alemtuzumab.

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 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 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. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

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®, Campath® and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved.

Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-703-797-1866 outside the United States.

About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


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.

 

Posted: January 2008


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