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Tanner Pharma Group has announced it is expanding its access program to provide to Leukine (sargramostim) in international markets. Leukine, now manufactured by Partner Therapeutics, 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. It is now being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) at University Hospital Ghent, Belgium to treat patients with respiratory illness associated with COVID-19.
“The collaboration we have had with Tanner Pharma Group has given us a regulatory-compliant pathway to make LEUKINE available in international markets,” said Bob Mulroy, CEO of Partner Therapeutics. “The expansion of this partnership makes Tanner our designated program manager and creates a shared objective to more effectively provide access to more patients in need.”
If a patient is located in a country where Leukine is not available commercially and has a life-threatening illness whereby survival could potentially be prolonged in a clinically meaningful way, physicians may be able to have Leukine imported for their patients through named patient supply via the LEUKINE EMERGENCY ACCESS PROGRAM (LEAP) managed by Tanner.
Banks Bourne, CEO of Tanner Pharma Group, commented: “Tanner has been managing this access program for Leukine since May of 2018 and we are ready for this new, very important phase. Our team is incredibly honored to be trusted with the expansion of this collaboration, and we are mobilized to help patients around the world to make a positive impact.”
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Tanner Pharma Group’s Banks Bourne speaks with Pharm Exec here.