Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today 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.
“According to the Centers for Disease Control and Prevention, the cause of death in most cases of acute radiation syndrome is the destruction of the person's bone marrow1,” said Richard Peters, Sanofi Genzyme’s Global Head of Rare Diseases. “We are pleased to be able to partner with BARDA to support public health.”
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 U.S. Food and Drug Administration next year.
BARDA provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public-health medical emergencies.
Leukine® (sargramostim) is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.
Important Safety Information for Leukine® (sargramostim)
Please see full prescribing information.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Leukine® is a registered trademark licensed to Genzyme Corporation. Genzyme® is a registered trademark of Genzyme Corporation. Sanofi® is a registered trademark of Sanofi. All rights reserved.
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1. CDC. 2016. Emergency Preparedness and Response - Radiation Emergencies. [ONLINE] Available at: http://emergency.cdc.gov/radiation/ars.asp. [Accessed 30 September 2016]
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Last updated on: 06/10/2016
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