On October 16, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, titled, "COMPOSITION OF BL-8040," which covers the composition of motixafortide (APHEXDA/BL-8040) (Press release, BioLineRx, OCT 16, 2024, View Source [SID1234647227]). The patent strengthens BioLineRx’s robust intellectual property (IP) estate and extends its patent protection on motixafortide in the U.S. through December 2041.
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"We are very pleased to significantly strengthen our motixafortide IP with this key Composition of Matter patent that, among other things, extends our protection on this drug substance through December 2041," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We believe this allowance reflects the USPTO’s acknowledgment of the unique attributes of motixafortide that make it a significant advancement among mobilization agents for multiple myeloma patients undergoing autologous stem cell transplantation, as well as the other high-need indications in which it is being investigated, including pancreatic cancer and gene therapies for patients with sickle cell disease (SCD)."
In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of data exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.
Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).