Sanofi Gets $37.6 Million US Gov’t Contract to Supply Radiation Drug TherapyBy
Sanofi Genzyme, the specialty care global business unit of Sanofi, has received a $37.6 million contract from the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, to supply and manage inventory for Leukine (sargramostim) for treating acute radiation syndrome, a condition involving injuries to the body’s organs, including the bone marrow, gastrointestinal tract, and lungs, and can cause neutropenia.
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 on the use of Leukine in patients acutely exposed to myelosuppressive doses of radiation. Sanofi Genzyme expects to submit a supplemental biologics license application to the US Food and Drug Administration next year.
Leukine is indicated in the US for the following uses: following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery; for mobilization and following transplantation of autologous peripheral blood progenitor cells; for myeloid reconstitution after autologous or allogeneic bone marrow transplantation; and for use in bone marrow transplantation failure or engraftment delay.
In addition to Leukine, BARDA also granted a $37.7 million contract to Amgen to supply Neulasta (pegfilgrastim) for treating adults and children exposed to high levels of radiation that damage bone marrow. Neulasta is indicated in the US for: the decrease of infection incidence, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and increase survival in patients acutely exposed to myelosuppressive doses of radiation.