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LEUKINE ACCESS PROGRAM

                                                                                                                                             

Tanner Pharma Group Announces LEUKINE ACCESS PROGRAM to Provide Access to LEUKINE® (sargramostim)

 

Tanner Pharma Group is now the designated program manager for international Leukine access (only if approved in your location) .
Contact us for international access:
leukine@tannerpharma.com
+1 (704)-643-8989

Additional contact information:

Medical information:  MedComm | 1-888-479-5385| 1-857-347-5730​ | partnertx@medcomminc.com
Adverse event reporting​:  MedComm | 1-888-479-5385​ | 1-857-347-5730 | partnertx@medcomminc.com


Official Press Release via BusinessWire
:
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.

“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.”

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
+44 (0) 80 0088 5809

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.

Contacts:

Christine Quern
CBQ Communications
cq@christinequern.com
617.650.8497

 

About Leukineâ (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.

Important Safety Information for LEUKINE® (sargramostim) 

Contraindications

  • LEUKINE® is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE®.

 

Warnings and Precautions

  • Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE®. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE® therapy and institute medical management. Permanently discontinue LEUKINE® in patients with serious allergic reactions.
  • LEUKINE® can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
  • Do not administer LEUKINE® simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
  • Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE® LEUKINE® should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
  • Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE® administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE® with caution in patients with preexisting cardiac disease.
  • If ANC > 20,000 cells/mm3 or if WBC counts > 50,000/mm3, LEUKINE® administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
  • LEUKINE® therapy should be discontinued if disease progression is detected during treatment.
  • Treatment with LEUKINE® may induce neutralizing anti-drug antibodies. Use LEUKINE® for the shortest duration required.
  • Liquid solutions containing benzyl alcohol (including LEUKINE® Injection) or LEUKINE® for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
  • Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE® should be avoided.

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE® in controlled clinical trials and reported in a higher frequency than placebo are:

  • In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
  • In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increase creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
  • In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema

Please see full Prescribing Information for LEUKINE® at www.leukine.com

Indications and Usage

LEUKINE® (sargramostim) is a leukocyte growth factor indicated for the following uses:

  • LEUKINE® is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
  • LEUKINE® is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
  • LEUKINE® is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).
  • LEUKINE® is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
  • LEUKINE® is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
  • LEUKINE® is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])