› THYMOGLOBULIN® / anti-thymocyte globulin (rabbit)
Our Transplant/Immune Diseases business is poised to begin benefiting from the anticipated launch in 2009 of Mozobil, a potential breakthrough stem cell mobilization agent for use in transplantation procedures, where having a sufficient quantity of stem cells is critical to success.
Data from phase 3 trials completed in 2007 for non-Hodgkin's lymphoma and multiple myeloma were extremely positive, showing that patients with these two types of cancer achieved more rapid and effective mobilization of stem cells in preparation for transplant than patients treated with current therapies alone. Because for these patients a transplant is sometimes their last hope for treatment, Mozobil could be a life-saving product.
We plan to file an NDA in the United States in the first half of 2008 and anticipate approval in 2009 for the first indication, stem cell mobilization for transplant. We are also planning to file in Europe with approval targeted for the second half of 2009. We intend to file in nearly 60 countries-we hope to have Mozobil approved in most of the world by 2010.
The economic benefits of Mozobil are compelling. A strong case can be made based on the significantly higher percentage of Mozobil patients who mobilize more stem cells for a transplant procedure compared with other methods. Faster and higher-volume stem-cell mobilization creates greater predictability and productivity that increases the number of patients who can proceed with the transplant and reduces costs to the system.
Early clinical and pre-clinical investigations are underway to study this important product's use in other settings- including Mozobil's ability to improve the effectiveness of chemotherapy in AML, and the role it could play in solid organ transplantation, cardiovascular disease and other major areas of medical need.
Thymoglobulin, Genzyme's standard-of-care therapy for treating and preventing acute organ rejection in renal transplant patients, saw growing demand in 2007, driven by strong medical need worldwide. With the FDA indicating satisfaction in late 2007 with our response to its warning letter earlier in the year regarding our Lyon, France, manufacturing processes, we are focused on building supply. Genzyme's new manufacturing facility in Lyon will break ground in 2008 with a plan to be delivering product by 2011. We're exploring Thymoglobulin's promise in other areas, supporting clinical studies for type-1 diabetes, myelodysplastic syndrome (MDS) and aplastic anemia in 2007.