TEL AVIV – BioLineRx Ltd. (NASDAQ:TASE: BLRX), a biopharmaceutical company focused on oncology and rare diseases, has announced the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for a patent on the composition of its drug motixafortide. The new patent extends the company's intellectual property protection in the United States through December 2041.
The patent, titled "COMPOSITION OF BL-8040," covers the composition of motixafortide, which is known commercially as APHEXDA®/BL-8040. This development is seen as a significant enhancement of BioLineRx's intellectual property estate and is expected to support the drug's longevity in the market.
Philip Serlin, CEO of BioLineRx, expressed satisfaction with the USPTO's recognition of motixafortide's unique attributes, particularly its role as a mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation. Motixafortide is also being investigated for use in pancreatic cancer and gene therapies for patients with sickle cell disease.
In addition to this patent, motixafortide has been the subject of a broad range of U.S. and international patents, covering various aspects such as methods of synthesis and use. The drug was granted seven years of Orphan Drug market exclusivity, which began on September 8, 2023, following FDA approval for use in autologous stem cell transplantation for multiple myeloma patients. Furthermore, five years of data exclusivity as a New Chemical Entity commenced on the same date, covering all indications.
Motixafortide has also received Orphan Drug Designation 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. The company's first approved product is APHEXDA®, indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma patients. The company continues to advance its pipeline of investigational medicines for various conditions.
This announcement is based on a press release statement from BioLineRx. The company's forward-looking statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected or implied. These risks are discussed in greater detail in the company's most recent annual report filed with the Securities and Exchange Commission.
In other recent news, BioLineRx has demonstrated strong financial performance, surpassing its Q2 2024 goals, driven by robust demand for APHEXDA. The biopharmaceutical company reported total revenue of $5.4 million and a net income of $0.5 million. With a cash reserve of $40.1 million, BioLineRx is well-positioned to fund its operations into 2025. The company's primary product, APHEXDA, received FDA approval and is now being used for stem cell transplantation in patients with multiple myeloma. BioLineRx is also conducting studies for potential use of APHEXDA in sickle cell disease and pancreatic cancer. Furthermore, the company is exploring market opportunities in Asia through strategic partnerships. Coverage of BioLineRx shares was initiated with a Buy rating and a $2.00 target by Jones Trading, which highlighted the significant growth prospects for BioLineRx not yet reflected in their current financial projections.
InvestingPro Insights
BioLineRx's recent patent approval for motixafortide comes at a crucial time for the company, as reflected in its financial metrics and market performance. According to InvestingPro data, BioLineRx's market capitalization stands at a modest $40.56 million, indicating its current position as a small-cap biopharmaceutical player.
The company's financial health presents a mixed picture. An InvestingPro Tip highlights that BioLineRx holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues to develop and commercialize its pipeline. This is particularly important given another InvestingPro Tip that notes the company is quickly burning through cash, a common characteristic of biopharmaceutical firms in the development stage.
Despite the positive news on the patent front, BioLineRx's stock has faced significant headwinds. The company's share price has fallen dramatically over the past year, with a one-year price total return of -71.77% as of the latest data. This decline aligns with an InvestingPro Tip suggesting the stock has performed poorly over the last month.
On a more optimistic note, analysts anticipate sales growth in the current year, which could be partly attributed to the potential of motixafortide and the expanded patent protection. However, it's worth noting that analysts do not expect the company to be profitable this year, underscoring the ongoing challenges faced by early-stage biopharmaceutical companies.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights beyond those mentioned here. In fact, there are 5 more InvestingPro Tips available for BioLineRx, providing a deeper understanding of the company's financial position and market outlook.
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