PBR Staff Writer Published 02 February 2018
Partner Therapeutics (PTx) has secured rights from Sanofi to develop, manufacture and commercialize Leukine (sargramostim).
Leukine is an immuno-stimulant that advances the growth and activation of a wide range of white blood cells, which activate the body’s immune response to battle infections.
PTx will involve in the development of Leukine for new indications. The firm plans to offer commercial and medical support to Leukine in the US, as well as explore chances for commercialization outside the US.
Leukine is claimed to be the only immune modulator secured approval from the US Food and Drug Administration (FDA) to treat acute myelogenous leukemia (AML) in older patients. It is also approved for use in both allogeneic and autologous bone marrow transplantation.
The deal also includes the acquisition of Sanofi’s biologics manufacturing facility in Lynnwood, Washington.
PTx will use the facility as core manufacturing and supply chain center to support its operations.
Said to be the only FDA-approved recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF), Leukine was showcased to enhance growth and activation of monocytes, macrophages, neutrophils and dendritic cells.
At present, Leukine is being studied tested in a Phase III trial in front-line melanoma in combination with ipilimumab and nivolumab. It is also being assessed to treat Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS).
In September 2017, a supplemental biologics licensing application (sBLA) was submitted to the FDA requesting approval of Leukine to treat H-ARS.
Partner Therapeutics CEO Robert Mulroy said: “The acquisition of Leukine provides us with an established commercial business, a product that has demonstrated a clear and substantial impact on outcomes, and a program with the potential to become a core component of immuno-oncology, the treatment of acute radiation syndrome and the treatment of infections.”