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FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
Date:9/22/2007

nsion add to a growing body of evidence about the effectiveness of Campath across the entire B-CLL treatment pathway," stated Mark Enyedy, president of Genzyme's oncology business unit. "A broader range of patients is now eligible for Campath treatment, regardless of whether they have received prior therapy. The approval also marks an important step in a long-term development plan that is exploring the full potential of Campath in high-risk CLL, combination and consolidation therapy."

Presented at the 48th Annual Meeting of the American Society of Hematology (ASH) conference last year, data supporting the sBLA were part of an international Phase III clinical trial comparing Campath with chlorambucil in previously untreated patients with B-CLL. The study met its primary endpoint by demonstrating longer progression free survival (PFS) in patients treated with Campath versus chlorambucil, with Campath reducing the risk of disease progression or death by 42 percent (p=0.0001).

Patients receiving Campath exhibited higher overall and complete response rates that were statistically significant in comparison to patients who were treated with chlorambucil. Campath also demonstrated a manageable safety profile among study patients.

"We are excited that Campath can now be used to treat patients in the U.S. earlier in the course of their disease," said Gunnar Riemann, Ph.D., member of the Board of Management of Bayer Schering Pharma AG. "The ability to now provide Campath as a first-line treatment of the disease will make an important difference in battling B-CLL. It may help patients by offering a potentially more effective treatment approach that can extend progression-free survival."

Campath is marketed in the U.S. by Bayer HealthCare Pharmaceuticals Inc., as Campath, and outside the United States as MabCampath(R).

About B-Cell Chronic Lymphocytic Leukemia

According to the Leukemia and Lymphoma Society, approximately 15,000 new cases of B-
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SOURCE Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
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