Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 71

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 71
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 be initiated, if at all. There can be no assurance that Gloria will meet its obligations
under the Gloria License Agreement. See “ Item 4. B. Information on the Company - Business Overview - Our Product Pipeline - Out
licensing of Motixafortide in Asia”.

Other Studies

In addition to the above, from time to time a number of Company-sponsored
and investigator-initiated studies may be conducted in a variety of indications, to support the interest of the scientific and medical
communities in exploring additional uses for motixafortide. These studies serve to potentially further elucidate the mechanism of action
for motixafortide, generate data about motixafortide’s potential use in other indications, and inform the life-cycle management
process of motixafortide. The results of studies such as these are presented from time to time at relevant professional conferences.

39

Orphan Drug Designations

Motixafortide has been granted three Orphan Drug Designations by
the FDA: for use to mobilize HSCs from the bone marrow to peripheral blood for collection in autologous or allogeneic transplantation
(granted in July 2012); for the treatment of AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February
2019). Orphan Drug Designation is granted to therapeutics intended to treat rare diseases or conditions that affect not more than 200,000
people in the United States (or diseases or conditions that affect more than 200,000 people but where there is no reasonable expectation
that the product development cost will be recovered from product sales in the United States). If an Orphan Drug-Designated product subsequently
receives FDA approval for the disease or condition for which it was designated, the product is entitled to a seven-year marketing exclusivity
period, which means that the FDA may not approve any other applications to market the same drug for the same indication, except in very
limited circumstances (such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness,
greater safety or providing a major contribution to patient care or in instances of drug supply issues), for seven years. In addition,
Orphan Drug Designation enables sponsors to apply for certain federal grants and tax credits for clinical trials and provides an exemption
from the Prescription Drug User Fee so long, as the sponsor’s annual revenue is below $50,000,000.

In January 2020, the EMA granted an