Sanofi has sold global rights to develop, manufacture, and commercialize Leukine (sargramostim), an immuno-stimulant drug, to Partner Therapeutics (PTx), a Boston, Massachusetts-based biopharmaceutical company focused on cancer, and sold a biomanufacturing facility in Lynnwood, Washington to PTx.

The facility is a biologics manufacturing plant that was certified for commercial production in 2012. The Lynnwood facility will serve as the core manufacturing and supply-chain center for PTx’s operations.

Leukine is an immune modulator approved by the US Food and Drug Administration (FDA) for treating acute myelogenous leukemia in older patients and for use in both allogeneic and autologous bone marrow transplantation. It is an immuno-stimulant designed to promote the growth and activation of a range of white blood cells important in activating the body’s immune response to fight infections.

PTx will support developing Leukine for new indications. The product is being tested in a set of clinical trials for its potential to improve survival and reduce adverse events in combination with immuno-oncology therapies. Sanofi filed a supplemental biologics licensing application (sBLA) in September 2017 with the FDA for treating hematopoietic syndrome of acute radiation syndrome. In December 2017, the FDA granted priority review to the sBLA with a Prescription Drug User Fee Act date of March 29, 2018.

PTx plans to provide commercial and medical support of Leukine in the US and explore commercialization opportunities outside the US.

Source: Partner Therapeutics