Biotech, FDA, Genzyme

Genzyme Applies for Approval of Stem-Cell Harvesting Drug

Erik Mellgren 6/17/08

Cambridge, MA-based Genzyme (NASDAQ: GENZ) announced today that it has applied for approval in the United States and the European Union of a new drug, Mozobil, that would aid the treatment of lymphoma and other cancers. The company plans to launch the drug in 2009 and expects it to eventually bring in $400 million per year.

Patients with lymphoma and multiple myeloma are often treated with high-dose chemotherapy to kill off the malignant white blood cells, but the treatment also destroys their blood-producing bone marrow. To get the marrow working again, doctors use transplants of stem cells previously harvested from a patient’s own blood. Mozobil is designed to boost the effectiveness and speed of this harvesting step—which can take several hours over a number of days and, for some patients, fails to yield enough cells—by helping mobilize the stem cells to move from the marrow into the blood.

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