Genzyme Receives Positive Opinion For European Approval Of Mozobil

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 02 Jun 2009 - 0:00 PDT

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Genzyme Corporation (Nasdaq: GENZ) announced that the European Medicines Agency's Committee for Human Medicinal Products (CHMP) has adopted a positive opinion on the marketing authorization application for Mozobil ® (plerixafor injection).

The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 66 calendar days to act on the CHMP's opinion.

In the EU, Mozobil would be indicated in combination with granulocyte-colony stimulating factor to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilize poorly.

"For many patients with lymphoma or multiple myeloma, moving on to a transplant is their only hope for remission or a cure," said Gerhard Ehninger, Professor of Medicine at Dresden Technology University and Chairman of the German Society of Hematology and Oncology. "Mozobil is an innovative treatment that, upon approval, can give these patients an opportunity to achieve a timely and successful transplant."

In order for a blood stem cell transplant to take place, a minimum number of such cells 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. Mozobil has been shown in clinical studies to rapidly and effectively increase the number of stem cells in circulation in the blood in patients with lymphoma and multiple myeloma.

In Europe, patients have received Mozobil through compassionate use and named patient programs.

In addition to its benefits for patients, Mozobil offers potential economic benefits to transplant centers by decreasing the number of days needed to collect stem cells, a procedure known as apheresis. This can provide transplant centers with a more predictable and efficient use of their apheresis centers. Mozobil may also reduce the number of patients who require a second mobilization procedure because of a failure to mobilize a sufficient number of cells.

Genzyme received FDA approval of Mozobil in December 2008. The company plans to submit additional applications in up to 60 countries.

About Mozobil

Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood in patients with non-Hodgkin's lymphoma and multiple myeloma. Once circulating in the blood, stem cells can be collected for use in an autologous stem cell transplant.

Source
Genzyme Corporation