Date: 2016-10-07
Type of information: Services contract
Compound: Leukine® (sargramostim)
Company: Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) (USA) Sanofi (France)
Therapeutic area: Hematological diseases
Type agreement: services contract
Action mechanism: protein. Leukine® (sargramostim) ) is a human recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) indicated :
Disease: acute radiation syndrome
Details: * On October 7, 2016, Sanofi Genzyme, the specialty care global business unit of Sanofi, announced that the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, has awarded Sanofi a $37.6 million contract to supply and manage inventory for Leukine®. Sanofi Genzyme is developing Leukine® for the treatment of acute radiation syndrome. Acute radiation syndrome is a serious illness that occurs in people exposed to high doses of radiation. The condition involves injuries to the body’s organs, including the bone marrow, gastrointestinal tract, and lungs, and can cause neutropenia, an abnormally low level of white blood cells that fight infection called neutrophils. In 2013, Sanofi was awarded a $36.5 million contract for late stage development and procurement of Leukine®. Since then Sanofi Genzyme has conducted studies regarding the potential use of Leukine in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). Sanofi Genzyme expects to submit a supplemental Biologics License Application (sBLA) to the FDA next year.
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