Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 72

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 72
---
 Orphan Drug Designation to
motixafortide for the treatment of pancreatic cancer. In addition, in December 2023, the EMA granted Orphan Drug Designation to motixafortide
for treatment of patients undergoing hematopoietic stem cell transplantation. The EMA grants orphan medicinal product designation to investigational
drugs intended to treat, prevent or diagnose a life-threatening or chronically debilitating disease affecting fewer than five in 10,000
people in the EU and for which no satisfactory treatment is available or, if such treatment exists, the medicine must be of significant
benefit to those affected by the condition. Orphan medicinal product designation provides regulatory and financial incentives for companies
to develop and market therapies, including ten years of market exclusivity, protocol assistance, fee reductions and EU-funded research.

BL-5010

Our commercialized, legacy therapeutic product, BL-5010, is a customized,
proprietary pen-like applicator containing a novel, acidic, aqueous solution for the non-surgical removal of skin lesions. It offers an
alternative to painful, invasive and expensive removal treatments including cryotherapy, laser treatment and surgery. Since the treatment
is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia, antiseptic precautions and bandaging. The pre-filled
device controls and standardizes the volume of solution applied to a lesion, ensuring accurate administration directly on the lesion and
preventing both accidental exposure of the healthy surrounding tissue and unintentional dripping. It has an ergonomic design, making it
easy to handle, and has been designed with a childproof cap. BL-5010 is applied topically on a skin lesion in a treatment lasting a few
minutes with the pen-like applicator and causes the lesion to gradually dry out and fall off within one to four weeks.

In December 2014, we entered into an exclusive out-licensing arrangement
with Perrigo Company plc, or Perrigo, for the rights to BL-5010 for over-the-counter, or OTC, indications in Europe, Australia and additional
selected countries. In March 2016, Perrigo received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal
of warts. The commercial launch of products for treatment of this first OTC indication (warts/verrucas) commenced in Europe in the second
quarter of 2016. Since then, Perrigo has invested in improving the product and during 2019 launched an