BARDA awards $37.6m contract to Sanofi to supply Leukine (sargramostim) for potential public health emergency

Sanofi Genzyme, the specialty care global business unit of Sanofi, has announced that 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, has awarded Sanofi a $37.6 million contract to supply and manage inventory for Leucine.

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 marrow,' 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 US 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.