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Genzyme gets US FDA approval for Mozobil

Cambridge, MarylandThursday, December 18, 2008, 08:00 Hrs  [IST]

Genzyme Corporation announced that the US Food and Drug Administration has granted marketing approval for Mozobil (plerixafor injection), a drug intended to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize haematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). The product has also been granted orphan drug designation. "Mozobil is an important advancement in the treatment of patients with certain types of cancer who require a stem cell transplant," said John F DiPersio, professor, Washington University, St Louis. "This product should become an integral part of the treatment regimen for transplantation because of the benefits it offers to patients, physicians and transplant centers." Mozobil is designed to mobilize haematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with certain types of cancers to proceed to transplant. Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs called growth factors to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are collected in preparation for a transplant. In order for the transplant to take place, a minimum number of approximately 2 million stem cells per kilogram of body 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. "For many cancer patients, moving on to a transplant is their only hope for remission or a cure," added Dr DiPersio. Genzyme will commercialize Mozobil in the United States through a blood and marrow transplant sales force that is part of the company's Transplant and Oncology business unit. This team of dedicated specialists will receive support from the business unit's oncology sales force to reach a targeted group of haematologists/oncologists and transplant specialists nationwide. This coordinated approach will support physicians and patients across the complementary customer base for these businesses. Genzyme also markets Clolar (clofarabine), a product indicated for the treatment of paediatric patients with relapsed or refractory acute lymphoblastic leukaemia after at least two prior regimens. The company recently filed a supplemental new drug application to expand the indication for Clolar to treat adult patients with acute myeloid leukaemia. Genzyme's drugs Campath (alemtuzumab) and Thymoglobulin (Anti-thymocyte Globulin [Rabbit]) are also used in the haematology/oncology setting. Genzyme has submitted an application in Europe for approval of Mozobil and expects approval of the product in the second half of 2009. Genzyme recently filed applications in Australia and Brazil, and additional global applications in up to 60 countries are planned. Mozobil has received orphan drug designation in Mexico which allows the product to be commercialized in the country upon US approval. Approximately 55,000 haematopoietic stem cell transplants are performed each year globally for multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma, and other conditions. Genzyme expects that over time and with further clinical development, Mozobil will be used in the majority of these procedures. Peak sales of the product in the transplant setting are projected to reach $400 million annually. Genzyme believes that Mozobil may have broad application outside the current indication. Early preclinical and clinical investigations are already underway to explore additional therapeutic indications for Mozobil, including mobilization of haematopoietic stem cells in allogeneic stem cell transplants and tumour sensitization in oncology/haematology treatments such as adult myeloid leukaemia. "Mozobil is an exciting and innovative new treatment that expands Genzyme's contribution to the field of Haematology and Oncology," said Joseph Lobacki, senior vice president and general manager, Genzyme Transplant and Oncology. "We look forward to strengthening our partnership with the blood marrow transplant community to make this product broadly available to patients who are facing transplantation procedures for non-Hodgkin's lymphoma or multiple myeloma."

 
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