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Genzyme Files Applications for Approval of Mozobil in the United States and Europe
Date:6/17/2008

weight must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible.

Genzyme conducted two phase 3 studies that confirmed the potential of Mozobil to effectively and predictably prepare lymphoma and multiple myeloma patients for an autologous transplant. Both studies successfully met primary and secondary endpoints. Patients who received Mozobil in conjunction with a growth factor achieved more rapid and effective mobilization of stem cells in preparation for autologous transplant than patients treated with growth factor alone. In addition, more patients treated with Mozobil plus a growth factor achieved a composite endpoint of optimal stem cell collection and successful transplantation, compared to patients mobilized with placebo plus a growth factor. Mozobil was well tolerated in both trials, with the most common adverse events being gastrointestinal effects and injection site reactions.

"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 United States, and similar compassionate use programs have recently begun in Europe.

Commercialization Plans

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.

Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin's and n
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SOURCE Genzyme Corporation
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