08:25 uur 25-03-2020

Tanner Pharma Group kondigt LEUKINE EMERGENCY ACCESS PROGRAM (LEAP) aan om meer internationale toegang tot LEUKINE® te bieden (sargramostim)

CHARLOTTE, N.C. – (BUSINESS WIRE) – Tanner Pharma Group heeft vandaag aangekondigd dat ze hun programma uitbreiden waarmee het bedrijf toegang biedt tot LEUKINE® (sargramostim) op internationale markten. LEUKINE®, goedgekeurd door de Amerikaanse FDA in 1991 en nu geproduceerd door Partner Therapeutics, is een recombinante granulocyte macrophage colony-stimulating factor (GM-CSF) die het immuunsysteem stimuleert en is gebruikt bij leukemie-patiënten om het risico op infectie te verminderen.

Op 23 maart 2020 kondigde Partner Therapeutics aan dat Leukine® wordt beoordeeld in het SARPAC-onderzoek (sargramostim bij patiënten met acute hypoxische respiratoire insufficiëntie als gevolg van COVID-19 – EudraCT # 2020-001254-22) in het Universitair Ziekenhuis Gent, België voor de behandeling patiënten met luchtwegaandoeningen geassocieerd met COVID-19.

Tanner Pharma Group Announces LEUKINE EMERGENCY ACCESS PROGRAM (LEAP) to Provide Increased International Access to LEUKINE® (sargramostim)

CHARLOTTE, N.C.–(BUSINESS WIRE)– Tanner Pharma Group today announced they are expanding their program by which the company provides access to LEUKINE® (sargramostim) in international markets. 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.

“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.

“Leukine has been an important part of the treatment regimen for various diseases over the past thirty years; now, there is an even greater possible need as demonstrated by initiation of the clinical trial in Belgium,” said Banks Bourne, CEO of Tanner Pharma Group. “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.”

For more information about this program or to request access to LEUKINE®:

Telephone: +1 704 643 8989

Email: leukine@tannerpharma.com

About LEUKINE® (sargramostim)

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.

About Tanner Pharma Group

Tanner Pharma Group partners with biopharmaceutical companies to provide turn-key commercialization 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. For more information, visit www.tannerpharma.com.


Christine Quern

CBQ Communications


Check out our twitter: @NewsNovumpr