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Tanner Pharma Group: Expands Ex-US Access Program to Provide LEUKINE® for Use in Patients with Respiratory Illness Associated with COVID-19

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March 8, 2021

Tanner Pharma Group (Tanner) today announced the expansion of the LEUKINE Access Program (LeAP) as a channel for distribution of LEUKINE® (sargramostim) in international markets.

LEUKINE®, approved by the US FDA in 1991 and now manufactured by Partner Therapeutics (PTx), is a recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) that stimulates the immune system and has been used in leukemia patients to reduce the risk of infection.

PTx recently announced that a clinical trial of Leukine® conducted in Belgium of hospitalized COVID-19 patients suffering from acute hypoxic respiratory failure requiring supplemental oxygen met the primary endpoint of the significant improvement in lung function. Improvement in oxygenation of at least 33% or more from baseline was seen in 54% of patients on the LEUKINE® plus standard-of-care (SOC) arm versus 26% of patients on SOC (p=.0147).

Tanner provides a regulatory-compliant pathway to make LEUKINE® available in international markets. If a patient is in a country where LEUKINE® is not available commercially physicians may be able to have Leukine® imported for their patients through named patient supply via LeAP managed by Tanner.

“As demonstrated by these positive clinical trial results, LEUKINE® has the potential to help COVID-19 patients,” said Banks Bourne, CEO of Tanner Pharma Group. “Our team is incredibly honored to be trusted with this important role, and we are mobilized to help patients and clinicians around the world gain access.”

LEUKINE® is currently being assessed in a clinical trial in the United States (NCT04411680) to further measure impact on COVID-19 patients.

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