CAMPATH United Kingdom

Gladys Slack: gardener and crossword puzzle enthusiast. Diagnosed with chronic lymphocytic leukemia in 2001, Gladys underwent three unsuccessful chemotherapy treatments. In 2003, she received MabCampath therapy and has had no recurrence or further treatment since then.

CAMPATH®/MABCAMPATH® alemtuzumab

CLOLAR® clofarabine

THYROGEN® thyrotropin alfa for injection

CAMPATH: NEARING FIRST-LINE STATUS
In 2006, we made substantial progress advancing Campath to a first-line therapy for B-cell chronic lymphocytic leukemia (B-CLL). The positive results showed that Campath demonstrated significantly better efficacy than its comparator with a manageable safety profile. In the trial, treatment with Campath reduced the risk of disease progression or death by 42 percent in comparison with first-line treatment chlorambucil. Additionally, the Campath patients had a nearly 30 percent greater overall response rate and a 12-fold increase in complete response rates. Based on these results, we will file for an expanded label in the first quarter of 2007 and anticipate accelerated approval by year-end. The label expansion would more than triple the number of potential U. S. Campath patients from approximately 2,500 to 9,500. This therapy is currently approved for the subset of B-CLL patients who have been treated with an alkylating agent and have failed fludarabine therapy.

We are also seeking other expansions of Campath in B-CLL. Our phase 3 trial of Campath in combination with fludarabine is progressing with the goal of full enrollment at the end of 2007. We are also evaluating additional studies with Campath in the subsets of B-CLL patients with poor or high-risk cytogenetics. These studies would entail a personalized approach that would employ Genzyme-developed diagnostics to enable physicians to identify patients with minimal residual disease or genetic mutations who could benefit from Campath treatment.

EXPANDING CLOLAR TO ADULTS
Genzyme is seeking to expand Clolar, approved for pediatric acute lymphoblastic leukemia, to benefit adults and children with acute myelogenous leukemia (AML). We have two pivotal clinical trials of Clolar for adult AML in progress and expect a phase 3 study sponsored by the Eastern Cooperative Oncology Group to begin in late 2007. We are also conducting post-marketing studies of Clolar in pediatric leukemia in combination with other agents with the goal of helping a broader group of children. Additionally, we plan to begin studies in myelodysplastic syndromes with an oral formulation of Clolar by mid-2007. Clolar sales increased by 50 percent in 2006 as we built our sales and marketing teams.

THYROID CANCER/ENDOCRINOLOGY
Thyrogen, our thyroid-stimulating hormone, continues geographic expansion and healthy organic growth. It has become the standard of care in managing thyroid cancer patients because of its role in helping them avoid the debilitating effects of becoming hypothyroid. In 2006, Thyrogen was cited in patient care guidelines in North America, Europe, and the Asia/Pacific region. There is also growth in Thyrogen use in Europe for remnant ablation following thyroid cancer surgery. In the United States, we expect approval for this indication by the end of 2007.