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Tanner Pharma is increasing inventory of Leukine® in Europe to expand availability and improve response to potential radiation exposure due to the ongoing conflict in Ukraine

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Leukine is approved by the FDA for the treatment of acute radiation syndrome (ARS) and recommended in the EMEA/CPMP guidelines for the treatment of systemic exposure to mustard gas (HD).

LONDON, March 25, 2022–(BUSINESS WIRE)–Tanner Pharma Group, an international distributor of essential medicines, announced that it has significantly increased its inventory of Leukine (Sargramostim, yeast-derived rhuGM-CSF) for storage in Europe. This action is being taken in collaboration with Leukine’s owner, Partner Therapeutics (PTx), in response to the ongoing war in Ukraine and the potential escalation of incidents that may require rapid deployment of medical interventions to treat radiation or exposure. chemistry.

“In response to the ongoing conflict in Ukraine, Tanner is supporting preparedness and response in Europe by increasing local inventory of Leukine, which can be rapidly deployed in response to an emergency,” said Banks Bourne, CEO and founder of Tanner Pharma. . This potency, which has been shown to improve survival when given within 96 hours of radiation exposure and without whole blood transfusions, makes it a highly effective countermeasure with significant logistical advantages in the event of a nuclear detonation. Europe ensures that more Leukine is available when needed.”

Leukine is an FDA-approved immune system modulator to treat the hematopoietic effects of acute radiation syndrome and has been used by the US government as a medical countermeasure since 2013. Leukine is also listed in the Medical Management of Injury 2020 International Atomic Energy Association (IAEA) Radiation Test for H-ARS Treatment(1) recommended and was used in 1986 to successfully treat some victims of the Chernobyl nuclear power plant.(two) In addition to ARS, Leukine is recommended as a treatment for mustard gas (HD) exposure in the EMEA/CPMP guidance document on the use of medicinal products to treat patients exposed to terrorist attacks involving chemical agents.(3) It is currently in development, but is not currently approved by the FDA for use against mustard sulfide exposure.

High doses of radiation profoundly damage the body’s immune system. Damaged cells include monocytes, macrophages, platelets, neutrophils, dendritic cells, and red blood cells, in other words, pancytopenia. Leukine stimulates each of these cell types and has been shown to speed recovery from pancytopenia. Its broad-spectrum effect allows longer survival of ARS without the need for blood transfusions. This is a key benefit given the expectation that blood products will be limited or unavailable after a nuclear or radiological event. It is also the only ARS countermeasure that has been shown to be effective when administered more than 24 hours after exposure. In fact, studies have shown efficacy when administered up to 96 hours after exposure. (4.5) After a radiological or nuclear event, a treatment window of 48 to 96 hours is absolutely critical. (6.7) The logistical challenges of preparing supplies and medical professionals for response and treatment suggest that it will take 2 days to deliver any medicine at any scale. Leukine is also stable for 12 months at room temperature, eliminating the need for a refrigerated supply chain in the event of a crisis.

Below is a summary of Leukine use for Acute Radiation Syndrome (ARS) and Sulfur Mustard Gas (HD) exposure provided by Partner Therapeutics:

ON LEUCINS IN ACUTE RADIATION SYNDROME (ARS)

Leukine is FDA-approved to prolong survival in patients exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome, or H-ARS). Data from multiple U.S. Biomedical Advanced Research and Development Authority (BARDA)-funded studies of GLP-NHP show that Leukine increases survival by stimulating thrombopoiesis and significantly increasing platelet counts, as well as accelerating recovery of leukocytes and reticulocytes, thus addressing the three main components of hematopoietic damage from radiation exposure, collectively pancytopenia. NHP studies show that Leukine improves survival and speeds recovery from myelosuppression (including thrombocytopenia) when given up to 96 hours after radiation exposure. (4,5,8) Leukine is not approved by the EMA for H-ARS.

Leukine is a recombinant yeast-derived form of granulocyte-macrophage colony-stimulating factor (GM-CSF), a small pleiotropic protein that promotes the formation of megakaryocyte and erythroid progenitors and stimulates the formation of progenitor cells within granulocytes and erythroids. Macrophage Divide and Differentiate Pathways Leucine induces the production, maturation, and differentiation of the myeloid lineages of hematopoietic progenitor cells, including the granulocyte, macrophage, platelet, dendritic cell, and red blood cell lineages. It also activates mature granulocytes and monocytes, increasing their phagocytic and lytic properties. Leukine’s effect on platelets, monocytes, macrophages, and dendritic cells has been demonstrated in various disease states in addition to its known effects on neutrophils and supports its use in H-ARS.

The FDA label for Leukine in ARS states: “To prolong survival in adult and pediatric patients from birth to 17 years of age who are acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome) . [H-ARS]);” leucine® For injection: See www.leukine.com/pi for information on how to prescribe Leukine.

ABOUT LEUCINS IN EXPOSURE TO SULFUR MUSTARD GAS (HD)

Leukine is not approved by the FDA or EMA for the treatment of HD gas exposure. Leukine is recommended as a treatment for HD gas exposure in the EMEA/CPMP guidance document on the use of medicinal products to treat patients exposed to terrorist attacks involving chemical agents.

HD exposure suppresses bone marrow function, resulting in myelosuppression and pancytopenia. Leukopenia has been reported in patients requiring hospitalization after exposure during World War I, World War II, and the Iran-Iraq War, and mortality has been reported in all cases in which white blood cell counts fell below of 200/µL.6. While mortality is reported in less than 2.5% of all people exposed to HD, hematological damage is the main reason for hospitalizations and severe hematological damage is the main cause of death. (10)

Leukin speeds recovery of bone marrow function and recovery from pancytopenia and reduces deaths from infections in people with bone marrow failure in a variety of settings, including after intensive chemotherapy and after acute body radiation. whole in high doses associated with hematopoietic cell transplantation.(4,5,8) Clinical experience in people receiving Leukine after chemotherapy and therapeutic radiation, as well as data from the GLP-NHP-ARS studies supporting the approval of Leukine and its use in these indications, show that Leukine improves recovery from bone marrow suppression and accelerated pancytopenia. In addition, it reduces the rate of infection and sepsis and probably provides the same benefit after HD exposure. (4-5,9-11)

Tanner offers an approval-compliant way to make Leukine available in international markets. If you would like more information about this program or would like to access Leukine, please email [email protected]

ABOUT THE TANNER PHARMA GROUP

Tanner Pharma Group partners with biopharmaceutical companies to offer turnkey solutions that expand patient access to medicines around the world. Tanner is expanding into more than 130 countries, providing customized solutions to biopharmaceutical companies outside of their core markets. For more information, visit our website at www.tannerpharma.com.

To learn more about Partner Therapeutics, visit https://www.partnertx.com/.

(1) Medical Treatment of Radiation Injuries, Vienna, International Atomic Energy Agency, 2020; Security Reports Serial No. 101

(2) Dainiak N., Medical Management of Acute Radiation Syndrome and Associated Infections in a High Casualty Incident, Journal of Radiation Research, Vol. 59, No. S2, 2018, pgs. ii54-ii64. doi:10.1093/jrr/rry004

(3) EMEA/CPMP Guidance Document on the use of medicines to treat patients subjected to terrorist attacks with chemical agents; European Agency for the Evaluation of Medicines, Pre-authorisation evaluation of medicinal products for human use, London, April 25, 2003; EMEA/CPMP/1255/03

(4) Clayton N, et al. (2021): Sargramostim (rhu GM-CSF) improves survival in nonhuman primates with severe bone marrow suppression after high-dose acute body irradiation, Radiation Research 195:191-199. https://doi.org/10.1667/RADE-20-00131.1

(5) ZhongY, et al. (2020): Efficacy of delayed administration of sargramostim up to 120 hours after exposure in a nonhuman primate whole-body irradiation model, Int. Radiation J. Biol.; https://doi.org/10.1080/09553002.2019.1673499

(6) Yeddanapudi N, et. al., (2018): Briefing CONOPS and deployment strategies for medical countermeasures after detonation of an improvised nuclear device: the importance of delayed treatment efficacy; International Radiation J. Biol.

(7) Pray L, et al., (2019): Research on Public Health and Medical Preparedness for a Nuclear Incident: Workshop Proceedings; National Academies Press. http://doi.org/10.17226/25372

(8) Gale R, Armitage J, (2021): Use of molecularly cloned hematopoietic growth factors in individuals exposed to acute high-dose whole-body ionizing radiation; blood scores 45; https://doi.org/10.1016/j.blre.2020.100690

(9) Leukine leaflet

(10) Willems, JL, Clinical Management of Mustard Gas Accidents, Ann Med Milit Belg 1989; 3:S1-61.

(11) Sezigan S. et. Al., Myelosuppression and acute hematologic complications of sulfur mustard exposure in victims of chemical terrorism, Toxikologische Briefe 318 (2020) 92-98.

The source language in which the original text is published is the official and authorized version. Translations will be included for better understanding. Only the version in the language that was originally published is legally valid. Therefore, compare the translations with the original language version of the publication.

View the original version on businesswire.com: https://www.businesswire.com/news/home/20220324005309/en/

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