Business Wire

Tanner Pharma Increases Europe-Based Inventory of Leukine® to Expand Availability and Enhance Response to Potential Radiation Exposure Due to the Ongoing Conflict in Ukraine

Share

Tanner Pharma Group, an international distributor of essential medicines, announced that it has significantly increased its inventory of Leukine (sargramostim, yeast-derived rhuGM-CSF) to be held in Europe. This action is being taken in partnership with Leukine’s owner, Partner Therapeutics (PTx), in response to the ongoing war in Ukraine and escalating potential for incidents that could require rapid deployment of medical interventions to treat radiation or chemical exposure.

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

Leukine is an immune system modulator that is FDA approved to treat the hematopoietic effects of acute radiation syndrome and has been held for use by the U.S. Government as a medical countermeasure since 2013. Leukine is also recommended to treat H-ARS in the International Atomic Energy Association (IAEA) 2020 Medical Management of Radiation Injuries(1) and was used to successfully treat some victims of the Chernobyl Nuclear Power Plant in 1986.(2) Beyond ARS, Leukine is recommended in EMEA/CPMP Guidance Document on the Use of Medicinal Products for the Treatment of Patients Exposed to Terrorist Attacks with Chemical Agents as a treatment for exposure to sulfur mustard (HD) gas.(3) It is currently under development, but not currently FDA-approved for use against sulfur mustard 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 is shown to accelerate recovery from pancytopenia. Its broad impact enables increased survival from ARS without the need for blood transfusions. This is a critical advantage given the expectation that after a radiological or nuclear event, blood products will be limited or unavailable. It is also the only ARS countermeasure that has been shown to be effective when administered more than 24 hours after exposure. In fact, the studies have shown efficacy when administered up to 96 hours after exposure. (4,5) In the aftermath of radiological or nuclear event, a 48-96 hour treatment window is absolutely critical. (6,7) The logistical challenges of making supplies and health care professionals available for response and treatment suggest it will be 2 days before drugs can be administered at any scale. Leukine is also stable at room temperature for 12 months, eliminating the need for a refrigerated supply chain in a crisis.

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

ABOUT LEUKINE IN ACUTE RADIATION SYNDROME (ARS)

Leukine is FDA approved to increase survival in patients exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome or H-ARS). Data from multiple GLP NHP studies funded by the U.S. Biomedical Advanced Research and Development Authority (BARDA) demonstrate that Leukine increases survival by stimulating thrombopoiesis and significantly increasing platelet count in addition to accelerating the recovery of leukocytes and reticulocytes, thereby addressing all three primary components of hematopoietic damage from radiation exposure, collectively pancytopenia. NHP studies show that Leukine improves survival and accelerates recovery from myelosuppression (including thrombocytopenia) when given up to 96 hours post radiation exposure. (4,5,8) Leukine is not EMA approved for H-ARS.

Leukine is a yeast-derived recombinant form of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), a pleiotropic small protein that promotes the generation of megakaryocytic and erythroid progenitors and induces progenitor cells to divide and differentiate within the granulocyte and macrophage pathways. Leukine induces production, maturation and differentiation of the myeloid lineages of hematopoietic precursor cells, including granulocyte, macrophage, platelet, dendritic cell and red cell lineages. It also activates mature granulocytes and monocytes, increasing their phagocytic and lytic properties. Leukine’s impact on platelets, monocytes, macrophages, and dendritic cells, in addition to its known effects on neutrophils, has been shown across several disease states and supports its use in H-ARS.

Leukine’s FDA label in ARS reads: “To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome [H-ARS]);” Leukine® for Injection: see www.leukine.com/pi for Leukine prescribing information.

ABOUT LEUKINE IN SULFUR MUSTARD (HD) GAS EXPOSURE

Leukine is not FDA or EMA approved to treat HD gas exposure. Leukine is recommended in EMEA/CPMP Guidance Document on the Use of Medicinal Products for the Treatment of Patients Exposed to Terrorist Attacks with Chemical Agents as a treatment for exposure to HD gas.

HD exposure suppresses bone marrow function, leading to myelosuppression and pancytopenia. Leukopenia was reported in patients requiring hospitalization after exposure during WWI, WWII and the Iran-Iraq War, and mortality was reported in all cases where leukocyte counts dropped below 200/µl6. While mortality is reported in less than 2.5% of all exposed to HD, hematological damage is the primary driver of hospitalization and severe hematological damage is the primary cause of mortality. (10)

Leukine accelerates recovery of bone marrow function and recovery from pancytopenia and decreases deaths from infections in persons with bone marrow failure under diverse circumstances including following intensive chemotherapy and after acute high-dose whole body radiation in the context of hematopoietic cell transplants.(4,5,8) Both clinical experience in persons receiving Leukine after chemotherapy and therapeutic radiation and data from GLP NHP ARS studies supporting Leukine’s approval and use in those indications, demonstrate that Leukine accelerates recovery from bone marrow suppression and pancytopenia and reduces the rate of infection and septicemia, and is likely to provide the same benefit after HD exposure. (4-5,9-11)

Tanner provides a regulatory-compliant pathway to make Leukine available in international markets. For more information about this program or to request access to Leukine, please email leukine@tannerpharma.com.

ABOUT TANNER PHARMA GROUP

Tanner Pharma Group partners with biopharmaceutical companies to provide turn-key solutions that increase patient access to medicines around the world. Expanding across 130+ countries, Tanner provides tailored solutions to biopharmaceutical companies outside their core markets of focus. For more information, visit www.tannerpharma.com.

For more information about Partner Therapeutics, visit https://www.partnertx.com/.

(1) Medical management of radiation injuries, Vienna, International Atomic Energy Agency, 2020; Safety Reports Series 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, p. ii54-ii64. Doi:10.1093/jrr/rry004

(3) EMEA/CPMP Guidance Document on the Use of Medicinal Products for the Treatment of Patients Exposed to Terrorist Attacks with Chemical Agents; The European Agency for the Evaluation of Medicinal Products Pre-authorisation Evaluation of Medicines for Human Use, London, 25 April 2003; EMEA/CPMP/1255/03

(4) Clayton N, et al. (2021): Sargramostim (rhu GM-CSF) Improves Survival of Non-Human Primates with Severe Bone Marrow Suppression after Acute, High-Dose, Whole-Body Irradiation, Radiation Research 195:191-199. https://doi.org/10.1667/RADE-20-00131.1

(5) Zhong Y, et al. (2020): Efficacy of delayed administration of sargramostim up to 120 hours post exposure in a non-human primate total body irradiation model, Int. J. Radiat. Biol.; https://doi.org/10.1080/09553002.2019.1673499

(6) Yeddanapudi N, et. al., (2018): Informing CONOPS and medical countermeasure deployment strategies after an improvised nuclear device detonation: the importance of delayed treatment efficacy; Int. J. Radiat. Biol.

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

(8) Gale R, Armitage J, (2021): Use of molecularly cloned haematopoietic growth factors in persons exposed to acute high-dose, high-dose rate whole-body ionizing radiations; Blood Reviews 45; https://doi.org/10.1016/j.blre.2020.100690

(9) Leukine Package Insert

(10) Willems, JL, Clinical management of mustard gas casualties, Ann Med Milit Belg 1989; 3: S1-61.

(11) Sezigan S, et. al., Myelosuppression and acute hematological complications of sulfur mustard exposure in victims of chemical terrorism, Toxicology Letters 318 (2020) 92-98.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Christine Quern
CBQ Communications
cq@christinequern.com
617.650.8497

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Align Announces Additional Leadership for UK and EMEA to Support Continued Growth18.5.2022 17:11:00 CEST | Press release

Align, the premier global provider of technology infrastructure solutions celebrates significant growth throughout the UK and EMEA markets with management changes to support increasing demand. The appointment of Giulia Marcolina as Managing Director and Mike Konold as AV Solutions Director of Align’s UK-based headquarters, will enable the team to deliver innovative collaborative technology and state-of-the-art AV solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220518005833/en/ Giulia Marcolina, a 15 year veteran with Align, is named Managing Director of Align's UK-based headquarters. (Photo: Business Wire) Giulia brings over 25 years of IT experience, previously serving as Align’s Programme Manager, delivering corporate office relocation and consolidation projects for clients such as Blackrock, Total Gas and Power, and UBS. In her new role, she will lead Align’s team of project managers in building upon Align’s lon

RMS Advances Climate Risk Modeling and Moves More Models to High Definition18.5.2022 16:30:00 CEST | Press release

RMS®, a Moody’s Analytics company and world-leading risk modeling and solutions company, today announces it will be releasing four new High Definition™ (HD) models, including Europe Windstorm, North America Winterstorm (WT), North America Severe Convective Storm (SCS), and Terrorism. RMS HD Models represent the next generation of risk modeling, delivering deeper analysis and granularity from Moody’s. The HD probabilistic models incorporate a high-fidelity, simulation-based framework for modeling event frequency and severity, to provide a major step forward in the quality of catastrophe risk quantification. The framework allows for event footprints to be represented more realistically across larger event sets. The new RMS Europe Windstorm HD Model further enhances the current model and will cover 17 countries, adding Finland and Lichtenstein. The HD model includes a climate variability view and has expanded storm surge analytics to include the U.K., Ireland, France, and Belgium. Storm c

Suketu Upadhyay Elected to Vertex Board of Directors18.5.2022 16:30:00 CEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Suketu (“Suky”) Upadhyayhas been elected to its board of directors as an independent director. Mr. Upadhyay is a global business executive with more than 20 years of experience in the pharmaceutical and medical technology sectors, serving in financial and strategy roles covering multiple areas of the life sciences sector. He is currently the Executive Vice President and Chief Financial Officer of Zimmer Biomet, a leading global innovator and manufacturer of orthopedic solutions, a position he has held since July 2019. “We are delighted to have Suky join the Vertex Board. His extensive financial and strategic experience in health care, paired with his leadership and expertise across biopharma and medtech, make him a valuable addition to our board of directors,” said Reshma Kewalramani, M.D., Vertex’s Chief Executive Officer and President. “It’s an honor to join Vertex, a company focused on serial innovation with an

Armory Makes Continuous Deployment Achievable and Effortless, at any Scale, for all Developers18.5.2022 16:17:00 CEST | Press release

Armory, the Continuous Deployment company empowering development teams to easily, reliably, safely, and continuously deploy software at any scale, today announced public early access to their new Continuous Deployment-as-a-Service product. Armory Continuous Deployment-as-a-Service delivers declarative deployments, across multiple environments, that support advanced strategies, so developers can focus on building great code rather than deploying it. “We believe deploying software continuously, at any scale, should be achievable and effortless for all developers of the world, not just the likes of Google and Netflix,” said Jim Douglas, President and CEO, Armory. “It’s our vision and mission to unlock innovation through software to make software continuous, scalable, secure, and safe, so developers can improve and protect their customers’ experience with confidence and ease.” To effectively compete in a software-defined world, development teams must ensure a stellar customer experience. S

Sermo Survey Reveals New Lung & Breast Cancer Research Rated as Most Interesting by Oncologists Attending ASCO This Year18.5.2022 15:15:00 CEST | Press release

A new survey from Sermo, a physician-first online community and leader in global HCP insights, timed to the annual American Society of Clinical Oncology (ASCO) conference found that nearly half (47%) of attending oncologists are most interested in new data being presented about lung cancer. This is followed by a similarly high interest in new data about breast cancer, as reported by 44% of oncologists surveyed. Additionally, oncologists/hematologists reported they are most excited about learning about tumor targeting antibodies treatments as reported by 54% of those surveyed. Ahead of ASCO’s Annual Meeting, new cancer research and innovations are the driving reason surveyed oncologists/hematologists are attending the conference this year (59%). However, how they plan to attend looks different to many oncologists, as only 18% of oncologists/hematologists surveyed said they will attend ASCO in-person this year. A Look Into the Pandemic’s Negative Impacts on Cancer Care Globally Oncologis

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom