TEL AVIV - BioLineRx Ltd. (NASDAQ:TASE: BLRX), a biopharmaceutical company focused on oncology and rare diseases, has been granted a Notice of Allowance by the U.S. Patent and Trademark Office for a manufacturing process of its drug motixafortide, which is suitable for large-scale production. This new intellectual property (IP) complements the U.S. market exclusivity previously awarded to the company's drug, APHEXDA® (motixafortide), which was approved by the FDA in early September for use in multiple myeloma patients.
The newly allowed patent, which will be valid until December 2041, adds to BioLineRx's existing portfolio of U.S. and international patents. It covers various aspects of motixafortide, including composition, synthesis methods, and combinations. BioLineRx CEO Philip Serlin emphasized the significance of this addition to their IP portfolio, as it supports the commercial demand for APHEXDA® and ongoing clinical trials for other indications, such as metastatic pancreatic cancer and gene therapies for sickle cell disease.
APHEXDA® received Orphan Drug market exclusivity for seven years starting from its FDA approval date, as well as five years of market exclusivity across all indications as a New Chemical Entity. These periods of exclusivity began concurrently on September 8, 2023. Orphan Drug Designation has also been granted to motixafortide in the U.S. and Europe for the treatment of pancreatic cancer and in the U.S. for acute myeloid leukemia (AML).
BioLineRx, headquartered in Israel with operations in the U.S., is driving the development and commercialization of innovative therapeutics. Its first approved product, APHEXDA®, is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients. The company is also advancing a pipeline of investigational medicines for patients with sickle cell disease, pancreatic cancer, and other solid tumors.
The information in this article is based on a press release statement from BioLineRx Ltd.
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