Israeli commercial stage biopharmaceutical company BioLineRx Ltd. (Nasdaq: BLRX; TASE: BLRX) today announced that the US Food and Drug Administration (FDA) has approved APHEXDA (motixafortide) in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA is administered by injection, for subcutaneous use.
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BioLineRx’s share price is up 5.6% on Nasdaq at $2.20, giving a market cap of $135.4 million. The share price has risen 320% over the past six months.
BioLineRx CEO Philip Serlin told “Globes” that the product will be ready for marketing in a few weeks. It is produced by subcontractors in the US and Europe, who are already prepared to produce it in commercial quantities. The product is considered an orphan drug (that is, it targets a relatively small market), and in the past Serlin explained that relatively few salespeople are needed to cover the bulk of the market, about 80 hospitals in the US where most transplants are performed. The product itself is relatively simple to manufacture and use as a subcutaneous injection. In addition to the US market, where it plans to operate alone, BioLineRx has also signed an agreement to market the product in the Asian market.
Multiple myeloma is the second most-common hematologic malignancy. Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and delivers prolonged survival for patients with this cancer type. The success of ASCT depends on adequate mobilization of stem cells during the treatment process.
As of the end of June 2023, BioLineRx had $32.8 million in cash. The company estimated that the amount would be enough to support its current activities, including the marketing of the new product after approval, into the first half of 2024. This calculation does not take into account $29.5 million, which should come from the agreement it has signed to market the product in Asia.
Published by Globes, Israel business news – en.globes.co.il – on September 11, 2023.
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