Our commercial oncology business made great strides in its first full year, delivering on the promise of personalized medicine for cancer patients by linking diagnostics and therapeutics.

In 2005, we successfully entered the oncology market. We launched Clolar, the first treatment approved specifically for pediatric patients in more than a decade; built out our commercial infrastructure with the addition of a sales force; and generated important new clinical data. We are well positioned for future growth.

Delivering personalized cancer treatments
Genzyme believes that effective cancer treatment requires personalized medicine, directing specific therapies at the patients most likely to benefit from them. In 2005, as we successfully integrated new businesses in cancer therapeutics and cancer diagnostics, we demonstrated our ability to deliver life-saving targeted medicine.

This important convergence of diagnostics and therapeutics first emerged during post-marketing research to support the expansion of Campath, which is currently approved for use in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. The data, published in the Journal of Clinical Oncology, not only supported the use of Campath to eliminate minimal residual disease (MRD) in relapsed or refractory B-CLL patients, but also showed the importance of diagnostic tools in disease management. In this study, 20 percent of patients achieved MRD-negative status - a status that correlates with long-term survival. MRD was measured in the trial using a flow-cytometry test, which we have now commercialized to guide physicians in treating B-CLL patients.

Following our comprehensive plan to expand the use of Campath to multiple lines of therapy in tandem with relevant diagnostics, we are on track to complete our trial of Campath as a first-line B-CLL therapy in 2006. We expect to file for expansion of Campath's label, which would increase the number of patients who could benefit from 2,000 to 7,000. Because early data also indicate that Campath has activity in B-CLL patients with mutations on the p53 gene - and because patients exhibit p53 mutations as their disease progresses - in 2006 we plan to initiate further studies in patients with poor or high-risk cytogenetics.

Expanding Clolar
We are also seeking to expand Clolar to benefit more patients, adults as well as children. In adults, we have begun the first of three parallel pivotal trials of Clolar in patients with acute myelogenous leukemia (AML). With the goal of expanding the product label to benefit a larger patient population, our strategy is to address multiple lines of adult AML. In children, we are conducting parallel clinical studies of Clolar in combination with existing therapies.

Thyroid cancer
Thyrogen, the standard of care in managing thyroid cancer patients, is an important adjunct to therapy because it can lead to earlier detection of recurrence and prevent deaths from this highly treatable disease. This product grew 23 percent in 2005. The high level of growth was due to dedicated sales forces in major countries and improved patient access to reimbursement as well as to the European approval of Thyrogen for use in remnant ablation following thyroid cancer surgery. We have received an approvable letter for this use from the FDA and anticipate approval in late 2006 in the United States, Brazil, and Canada.