Blood Cells

Genzyme, one of the world’s leading biotechnology companies, has acquired the worldwide marketing and distribution rights to fludarabine phosphate (Fludara?) and sargramostim (Leukine?), which significantly expands Genzyme?s global oncology commercial presence.

Genzyme now has full responsibility for developing, marketing and selling the acquired oncology products and will record sales revenue in the United States and more than 90 other countries where they are sold. During a transition period following the closing, Genzyme and Bayer HealthCare will continue to work together to ensure no interruption in product supply to patients or support services to providers.

A comprehensive set of treatment options
?With our broad portfolio of new and existing innovative therapies, combined with a large array of genetic testing services, Genzyme is positioned to offer patients and physicians a comprehensive set of treatment options across the continuum of care for hematologic malignancies,? said Mark Enyedy, president of Genzyme Oncology.

Oncology Expansion
The transaction leverages Genzyme?s international commercial infrastructure within the areas of transplantation and hematologic malignancies. Genzyme?s hematologic oncology sales force, which will expand in the United States and globally with the addition of fludarabine phosphate and sargramostim, will support a comprehensive portfolio of products covering acute and chronic leukemia, bone-marrow transplant and managing post-transplant complications.

Sargramostim is expected to see continued growth through the company?s specialized sales force and further clinical development. fludarabine phosphate, marketed broadly worldwide, are recognized therapeutic options for patients with B-cell chronic leukemia. sargramostim, marketed in the United States, reduces the incidence of severe and life-threatening infections in older adult patients with AML following chemotherapy and is also used to mobilize stem cells.

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This new and significant global market presence can also accelerate the adoption of clofarabine injection (Clolar?/Evoltra?) and plerixafor injection (Mozobil?). Genzyme is introducing these drugs throughout the world and continues to invest in their development. Peak sales for these products are expected to generate approximately $1 billion in revenue.

Clofarabine injection, marketed in the United States and Europe (where it is known under the trade name Evoltra?), has become the standard of care for the treatment of acute lymphoblastic leukemia in relapsed and refractory pediatric patients. Genzyme?s supplemental New Drug Application for clofarabine injection to treat older adults with newly diagnosed acute myeloid leukemia (AML) will be reviewed in September by the U.S. Food and Drug Administration?s Oncologic Drugs Advisory Committee.

Plerixafor injection, launched in the United States earlier this year, mobilizes hematopoietic stem cells in patients with non-Hodgkin?s lymphoma and multiple myeloma for subsequent autologous stem-cell transplants. The launch of plerixafor injection in the United States is proceeding well due to the clinical benefits it offers patients and the potential economic benefits to transplant centers. European Union approval of plerixafor injection is expected in the second half of 2009, and the company plans to submit additional applications in up to 60 countries.

Last editorial review: June 2, 2009.

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