Research & Development
Tanner Pharma Group Expands Leukine Emergency Access Programme
25 March 2020 - - US-based biopharmaceutical commercialisation solutions provider Tanner Pharma Group is expanding a program by which the company provides access to Leukine (sargramostim) in international markets, the company said.

Leukine, approved by the US FDA in 1991 and 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.

On March 23, 2020, Partner Therapeutics announced that Leukine is being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19 EudraCT #2020-001254-22) at University Hospital Ghent, Belgium to treat patients with respiratory illness associated with COVID-19.

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 Programme managed by Tanner.

Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF.

GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Tanner Pharma Group partners with biopharmaceutical companies to provide turn-key commercialisation solutions to increase patient access to medicines around the world.

With an unparalleled blend of local market knowledge, international supply chain expertise across more than 130 countries, and high regulatory compliance and quality standards, it provides tailored solutions to biopharmaceutical companies outside their core markets of focus.
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