Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 168

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 4
Chunk 168
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id License Agreement with Ayrmid, pursuant to which we granted to Ayrmid an exclusive, transferable, royalty-bearing, sublicensable license with respect to the intellectual property rights and know-how associated with motixafortide, in order to commercialize motixafortide across all indications, except solid tumor indications, in all territories other than Asia. For additional information concerning the Ayrmid License Agreement, see “Item 4.B. Information on the Company — Business Overview — Recent Developments — Out Licensing of Motixafortide in All Territories Except Asia.”
 
The following is a summary of the motixafortide clinical trials.
 
Stem cell mobilization
 
Multiple Myeloma
 
High-dose chemotherapy followed by stem cell transplantation is an established treatment modality for a variety of hematologic malignancies, including multiple myeloma (MM), as well as various forms of lymphoma and leukemia. Stem cells are mobilized from the bone marrow of the patient (i.e., autologous transplant) or donor (i.e., allogeneic transplant) using granulocyte-colony stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after intensive myeloablation (chemo/radiotherapy).
 
In 2021, approximately 40,000 autologous transplants were conducted in the U.S. and EU. It is estimated that approximately two-thirds, i.e., 60-70% of patients undergoing autologous transplantation in the U.S. receive plerixafor on top of G-CSF.  Based on our internal assessment, we estimate the value of the U.S. stem cell mobilization market at approximately $300 million in 2023.
 
Multiple myeloma is the second most-common hematologic malignancy. Multiple myeloma is an incurable blood cancer that affects certain white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow. According to the American Cancer Society, in 2024, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma, and nearly 13,000 people will die from the disease in the U.S. While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems, or infections