Genzyme Files Mozobil in U.S., EU

Genzyme Corp. has submitted marketing applications in both the U.S. and the EU for Mozobil, a drug intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma. The company has requested priority review of its U.S. application and, if granted, Mozobil could be approved by the end of this year. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.

Mozobil is designed to mobilize stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for a patient with certain types of cancers to receive a successful transplant. Specifically, patients with non-Hodgkin’s and Hodgkin’s lymphomas and multiple myeloma often receive high-dose chemotherapy, a process that destroys bone marrow. A stem cell transplant is required to replenish blood-forming bone marrow cells destroyed by high-dose chemotherapy. Stem cells differentiate into the mature red blood cells, white blood cells, and platelets that a healthy person needs.

“There is a lot of excitement among treating physicians about Mozobil,” said Mark Goldberg, M.D., senior vice president of clinical research at Genzyme. “The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients.”

More than 900 patients have received Mozobil through a compassionate use program in the U.S., and similar compassionate use programs have recently begun in Europe.

Genzyme plans to launch Mozobil in the U.S. and Europe in 2009. Upon commercial launch, Mozobil will be marketed and sold by Genzyme’s existing Transplant sales force, which has a commercial presence in more than 55 countries worldwide. In addition, the company will leverage its Oncology business and clinical infrastructure.