Geographic expansion
Thymoglobulin is well established in the United States, Canada, and, with a label for broader use, in Europe. We are
now bringing this product to new regions in Asia, the Pacific, and Latin America. In 2005, we anticipate filing for
approval of Thymoglobulin in Australia. We also expect to commercialize Thymoglobulin in Latin America. We have filed
for approval of this product in Japan, where we also market Lymphoglobuline for severe aplastic anemia.
To meet increasing demand, in 2004 we made significant process and quality assurance improvements in our
manufacturing facility in Lyon, France. We are also integrating Thymoglobulin into our own distribution system.
In 2005, we plan to begin packaging at our Haverhill plant and to move the finishing operation to our Waterford
facility in 2006. We are centralizing customer service in the Netherlands and the United States.
Investigating new uses
With the goal of improving the long-term health of patients, we are expanding the market for Thymoglobulin with
studies and publications of new uses. In January 2005, we completed enrollment in a clinical trial of this product
to prevent rejection in recipients of living donor kidney transplants and help mitigate serious side effects. We
expect to present interim data at the American Transplant Congress in May 2005. We also began enrollment of a trial
of Thymoglobulin as a conditioning therapy for bone marrow transplant in patients with severe leukemia. In early
2005, we initiated a trial of Thymoglobulin induction in the liver, which we hope to complete during the year. After
the kidney, the liver is the organ most often transplanted.
Genzyme is committed to the wide range of immune-mediated diseases. We are studying a number of product candidates
and believe that Thymoglobulin has potential beyond transplant. Because we are focused on breakthrough products, we
are exiting the market for the generic cyclosporine and Gengraf.
