BioLineRx Receives USPTO Approval for New Motixafortide Patent

BioLineRx Ltd., a biopharmaceutical firm known for its work in oncology and rare diseases, has recently announced a significant development in its intellectual property portfolio. The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent related to the composition of motixafortide, also known as APHEXDA® or BL-8040. This new patent ensures that BioLineRx's intellectual property rights for motixafortide in the United States will be extended until December 2041.

Philip Serlin, the company's Chief Executive Officer, expressed satisfaction over this achievement. He emphasized that this patent not only solidifies their intellectual property rights but also highlights the innovative nature of motixafortide. Serlin pointed out that the patent's approval underscores the drug's unique properties, which represent a significant advancement for mobilization agents used in autologous stem cell transplantation for multiple myeloma patients. In addition to multiple myeloma, motixafortide is being investigated for its potential applications in treating pancreatic cancer and sickle cell disease (SCD).

BioLineRx holds a comprehensive suite of patents for motixafortide, both in the United States and internationally. These patents cover various facets, including the composition of matter, methods of synthesis, usage methods, and combinations. The company has also been granted seven years of Orphan Drug market exclusivity in the U.S., starting from September 8, 2023, the day the FDA approved APHEXDA® in combination with G-CSF for multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide benefits from five years of data exclusivity across all indications as a New Chemical Entity (NCE), also beginning from September 8, 2023.

Motixafortide has received Orphan Drug Designation in both the U.S. and Europe for the treatment of pancreatic cancer. In the U.S., it has also been designated for the treatment of acute myeloid leukemia (AML).

BioLineRx Ltd. is a commercial stage biopharmaceutical company that focuses on developing therapies for oncology and rare diseases. Headquartered in Israel with operations in the U.S., the company aims to advance a pipeline of investigational medicines. Their first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization in autologous transplantation for multiple myeloma patients. Beyond multiple myeloma, BioLineRx is exploring treatments for conditions such as sickle cell disease, pancreatic cancer, and other solid tumors.

The company's mission is to push forward innovative therapeutics from research to commercialization, ensuring that groundbreaking discoveries reach patients effectively. BioLineRx is committed to leveraging its expertise to meet high medical needs and improve patient outcomes, particularly in areas where current treatment options are limited.

This latest development reflects BioLineRx's ongoing efforts to secure and expand its intellectual property rights, thereby reinforcing its position in the biopharmaceutical industry. The extended patent protection for motixafortide in the U.S. marks a critical step in the company's strategy to provide long-term solutions for patients suffering from severe medical conditions.