We made substantial progress in 2005 on the global expansion of Thymoglobulin. This product, our commercial entry into diseases of the immune system, is the standard of care for the prevention and treatment of acute rejection in kidney transplant patients in the United States and Canada as well as in Europe, where it is approved for broader use. During 2006, we anticipate receiving regulatory approvals in the United Kingdom, Australia, and Mexico. We have also filed for approval in Japan.
We are now marketing Thymoglobulin directly in Brazil, Colombia, and Argentina, and we are moving toward direct sales in China, where this product has been sold for a decade. In 2006, we plan to establish a presence in central and eastern Europe. We are benefiting from improvements made in 2004 at our manufacturing plant in Lyon, France. To meet the increasing global demand and ensure a reliable supply, we have qualified our new plant in Waterford, Ireland, to handle the Thymoglobulin finishing operation. We hope to receive approval for this plant from the FDA in 2006.
Expanding uses
In 2005, we moved further toward our goal of serving more patients with Thymoglobulin. We completed enrollment in a phase 2 trial of this product to prevent rejection of transplanted kidneys from living donors and published promising interim results. We aim to complete this trial in 2006. After the kidney, the liver is the organ that is transplanted most often, and in 2005 we began a phase 2 trial of Thymoglobulin induction in the liver. We closed our trial of Thymoglobulin as a conditioning therapy for bone marrow transplant in cases of severe leukemia in order to devote our efforts to other aspects of hematological cancers.
Beyond transplant therapies
We are exploring Thymoglobulin's potential in uses beyond transplantation. Because of the great unmet need represented by Type 1 diabetes, we are investigating Thymoglobulin as an induction agent in this immune-mediated disease and hope to begin a clinical trial in late 2006. We also continue to collaborate with the Immune Tolerance Network regarding Thymoglobulin and Type 1 diabetes. Additionally, we are in the late preclinical phase of studying our proprietary molecule Genz-29155 for induction in solid organ transplant.
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