In 2004, Genzyme established a commercial oncology franchise to provide comprehensive cancer care from diagnostics to therapeutics to follow-up monitoring.

Campath is significantly improving treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. Developed jointly with Schering AG, it is the first and only monoclonal antibody to win FDA approval for treating patients with B-CLL. Studies are currently underway to expand Campath's label for earlier-line use in B-CLL and in other cancers and diseases, including multiple sclerosis.

In the last days of 2004, the FDA granted marketing approval for Clolar, the first new leukemia drug approved specifically for children in more than a decade. Clolar is indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL). Because of the extreme need of these patients, Genzyme launched the drug and was taking orders from leading cancer centers across the country within two weeks of the approval. An estimated 3,400 new cases of pediatric acute leukemia, of which ALL is the most common form, will be diagnosed in the United States in 2005. Today the market for Clolar is approximately 500 to 1,000 patients per year. Genzyme will conduct post-marketing evaluation of the drug in pediatric ALL in combination with existing therapies, and we are also investigating it in adult cancers and solid-tumor indications.